source_file stringlengths 9 26 | drug_name stringlengths 4 87 | last_updated stringdate 2014-02-16 00:00:00 2025-04-25 00:00:00 | introduction stringlengths 120 6.31k ⌀ | background stringlengths 419 9.32k ⌀ | hepatotoxicity stringlengths 209 9.23k ⌀ | mechanism_of_injury stringlengths 54 1.77k ⌀ | outcome_and_management stringlengths 36 2.91k ⌀ | trade_names stringlengths 6 99 ⌀ | drug_class stringclasses 171
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|---|---|---|---|---|---|---|---|---|---|---|
Procarbazine.nxml | Procarbazine | 2020-09-12 | Procarbazine is an orally administered alkylating agent used in combination with other antineoplastic agents in the therapy of Hodgkin’s disease and malignant melanoma. Procarbazine therapy has been associated with serum enzyme elevations during therapy and with rare cases of idiosyncratic, clinically apparent acute li... | Procarbazine (proe kar' ba zeen) is a methylhydrazine derivative which is activated in the liver to highly reactive alkylating intermediates. These intermediates methylate DNA which causes inhibition of DNA, RNA and protein synthesis and cell death. Procarbazine was approved for use in the United States in 1969 and it ... | Mild and transient elevations in serum aminotransferase levels are not uncommon during courses of systemic combination chemotherapy and the role of procarbazine in these abnormalities is often not clear. Aminotransferase elevations arise in more than half of patients and rise above 5 times ULN in 10 to 20% of patients.... | The mechanism of hepatotoxicity from procarbazine is not known, but may be due to hypersensitivity. | The severity of liver injury from procarbazine is usually mild and self-limiting. Procarbazine therapy has not been associated with cases of acute liver failure, chronic liver injury or vanishing bile duct syndrome. The product label for procarbazine recommends obtaining routine liver and kidney tests before starting a... | Procarbazine – Matulane® | Antineoplastic Agents, Alkylating Agents | null |
Liraglutide.nxml | Liraglutide | 2019-04-10 | Liraglutide is a recombinant DNA produced polypeptide analogue of human glucagon-like peptide-1 (GLP-1) which is used in combination with diet and exercise in the therapy of type 2 diabetes, either alone or in combination with other antidiabetic agents. There have been no published reports of hepatotoxicity attributed ... | Liraglutide (lir" a gloo' tide) is a glucagon-like peptide-1 (GLP-1) analogue that acts like the native gastrointestinal hormone (incretin) to increase insulin secretion. Liraglutide reproduces the activity of GLP-1, binding to specific receptors on pancreatic beta cells and increasing insulin secretion, which can lead... | In large clinical trials, serum enzyme elevations were no more common with liraglutide therapy than with placebo or comparator agents, and no instances of clinically apparent liver injury were reported. Since licensure, there has been a single case report of autoimmune hepatitis arising in a patient taking liraglutide.... | Liraglutide is a polypeptide and is metabolized to amino acids by serum and tissue proteases, and is unlikely to have any direct hepatotoxic potential. Liraglutide acts through the incretin pathway to affect glucose metabolism and, thus, is often grouped with other incretin-based antidiabetic mediations such as the DPP... | null | Liraglutide – Victoza® | Antidiabetic Agents | null |
Clemastine.nxml | Clemastine | 2017-01-16 | Clemastine is a first generation antihistamine that is used for symptoms of allergic rhinitis and the common cold. Clemastine has not been linked to instances of clinically apparent acute liver injury. | Clemastine (kle mas' teen) is a first generation antihistamine that is used for alleviation of symptoms of allergic rhinitis, the common cold and allergic urticaria, including sneezing, cough, runny note, watery eyes and itching. Clemastine belongs to the ethanolamine class of antihistamines (with diphenhydramine and d... | Despite widespread use, the first generation antihistamines such as clemastine have rarely been linked to liver test abnormalities or to clinically apparent liver injury. The reason for their safety may relate to low daily dose and limited duration of use.\n\nLikelihood score: E (unlikely to be a cause of clinically ap... | null | null | Clemastine – Generic, Dayhist Allergy®, Tavist Allergy® | Antihistamines | null |
Tinidazole.nxml | Tinidazole | 2020-02-20 | Tinidazole is an orally available, broad spectrum antimicrobial agent used in the treatment of bacterial, protozoal and parasitic infections. Tinidazole is a nitroimidazole similar to metronidazole and is likely to have a similar spectrum and frequency of side effects, including a low rate of serum enzyme elevations du... | Tinidazole (tye nid' a zole) is an oral, broad spectrum antimicrobial that has activity against bacteria as well as several parasites such as Entamoeba histolytica, Giardia duodenalis and Trichomonas vaginalis. Tinidazole is a nitroimidazole similar to metronidazole and is activated intracellularly by bacterial or para... | Tinidazole is typically given for a few days only, but serum enzyme elevations have been reported with its use, and serum enzyme elevations during therapy is listed as a possible adverse event in the product label. Tinidazole is also capable of causing anaphylactic and allergic reactions including urticaria, angioedema... | The cause of rare instances of serum enzyme elevations with tinidazole therapy is unknown, but is likely to be immunologically mediated. Tinidazole is extensively metabolized in the liver largely via CYP 3A4 and can lead to significant drug-drug interactions. | The severity of the liver injury linked to tinidazole therapy has been invariably mild and self-limited, usually with transient, asymptomatic serum enzyme elevations accompanying hypersensitivity reactions. However, the use of tinidazole has been limited and it is typically given for 1 to 5 days only. In instances of a... | Tinidazole – Generic, Tindamax® | Antiinfective Agents | null |
Repotrectinib.nxml | Repotrectinib | 2025-04-07 | Repotrectinib is a small molecule inhibitor of the proto-oncogene tyrosine-protein kinase ROS1 and of tropomyosin receptor tyrosine kinases (TRK-A, -B and -C) and is used to treat adults with non-small cell lung cancer. Repotrectinib is associated with a moderate rate of mild transient elevations in serum aminotransfer... | Repotrectinib (re poe trek’ ti nib) is a small molecule inhibitor of the proto-oncogene tyrosine-protein kinase ROS1 and of tropomyosin receptor tyrosine kinases (TRKA, B and C) and is used to treat adults with non-small cell lung cancer (NSCLC). Lung cancer is the leading cause of cancer deaths in the United States an... | In the prelicensure trials of repotrectinib as therapy of ROS1-positive NSCLC, liver test abnormalities were frequent but usually mild-to-moderate in severity and self-limited in duration. ALT elevations arose in 34% and AST in 40% and were above 5 times the ULN in 3.1% and 1.9% of the 264 patients treated in the major... | The causes of serum enzyme elevations or liver injury from repotrectinib therapy are possibly due to direct toxicity of the ROS1 pathway inhibition, but some are likely related to hepatic metastases from the underlying advanced lung cancer. Repotrectinib is metabolized in the liver largely via CYP 3A4 and is susceptibl... | The product label for repotrectinib recommends monitoring of liver tests before therapy, every 2 weeks during the first month, and every month thereafter and as clinically indicated. Serum aminotransferase elevations above 5 times the upper limit of normal (if confirmed) or any elevations accompanied by jaundice or sym... | Repotrectinib – Augtyro® | Antineoplastic Agents | null |
Lubiprostone.nxml | Lubiprostone | 2019-04-25 | Lubiprostone is an activator of chloride channels (ClC-2) in the intestine and is used for treatment of chronic constipation and irritable bowel syndrome. Lubiprostone has not been linked to serum enzyme elevations during treatment or to episodes of clinically apparent liver injury. | Lubiprostone (loo” bi pros’ tone) is a fatty acid metabolite of prostaglandin E1 that activates the chloride channel protein 2 in the intestine, which increase fluid secretion into the lumen and thus promote intestinal transport. Short term use of lubiprostone increases the number of spontaneous bowel movements and can... | In clinical trials, lubiprostone therapy was not associated with significant changes in serum enzyme levels or episodes of clinically apparent liver injury. Since its approval and marketing, isolated case reports of serum aminotransferase elevations have been reported to the sponsor, but there have been no published re... | Lubiprostone is largely active on the epithelial cells in the intestinal tract and has minimal absorption. The lack of systemic absorption of lubiprostone and the low daily doses used (in micrograms rather than milligrams) probably account for its lack of causing liver injury.\n\nDrug Class: Gastrointestinal Agents, Dr... | null | Lubiprostone – Amitiza® | Gastrointestinal Agents | null |
Apomorphine.nxml | Apomorphine | 2017-07-20 | Apomorphine is a subcutaneously administered dopamine receptor agonist used predominantly in the therapy of hypomobility of advanced Parkinson disease. The use of apomorphine has been limited, but it has not been associated with serum enzyme elevations during treatment nor has it been implicated in cases of acute liver... | Apomorphine (a" poe mor' feen) is a subcutaneously administered dopamine receptor agonist which has moderate affinity for the D2, D3, and D5 class of dopamine receptors in the central nervous system and little activity against the D1 class. It also has some alpha adrenergic activity. Apomorphine was shown to improve mo... | Apomorphine has not been reported to cause serum aminotransferase elevations or clinically apparent acute liver injury, but its use has been limited and is typically given in low doses for a limited period of time. Thus, if apomorphine causes liver injury it must be rare.\n\nLikelihood score: E (unlikely cause of clini... | The metabolism of apomorphine has not been well defined; it appears to be minimally metabolized in the liver.\n\nDrug Class: Antiparkinson Agents\n\nOther Drugs in the Subclass, Dopamine Receptor Agonists: Bromocriptine, Pergolide, Pramipexole, Ropinirole, Rotigotine | null | Apomorphine – Apokyn® | Antiparkinson Agents | null |
Quinidine.nxml | Quinidine | 2018-05-10 | Quinidine is a natural cinchona alkaloid which has potent antiarrhythmic activity and has been used for decades in the treatment of atrial and ventricular arrhythmias. Quinidine has been associated with fever, mild jaundice and clinically apparent liver injury in up to 2% of treated patients. | Quinidine (kwin' i deen) and its stereoisomer quinine (kwye' nine) are natural cinchona alkaloids found in the powdered bark of the American cinchona tree. The bark powder was used for centuries in the prevention and therapy of malaria, but was also known to decrease heart palpitations. Quinidine was found to be the mo... | Chronic therapy with quinidine is associated with a low rate of serum enzyme elevations, which are usually mild, asymptomatic and self limited even without alteration in dose. In addition, there have been many reports of acute hypersensitivity reactions to quinidine that include hepatic involvement. The reactions usual... | The hepatotoxicity of quinidine is clearly due to a hypersensitivity reaction and there is no evidence for a direct hepatotoxic effect of the drug. There is likely to be a genetic predisposition to this hypersensitivity. | The hepatotoxicity of quinidine is clearly a part of a hypersensitivity reaction and is usually mild, resolving within 1 to 4 weeks of stopping. In many instances, jaundice and liver test abnormalities may worsen for a few days after stopping, but fatalities have not been reported and recovery is usually rapid. Because... | Quinidine – Generic | Antiarrhythmic Agents | null |
Quizartinib.nxml | Quizartinib | 2024-07-21 | Quizartinib is an orally administered receptor tyrosine kinase FLT3 inhibitor that is used in combination with other cancer chemotherapeutic agents to treat adults with acute myelogenous leukemia who are positive for FLT3 internal tandem duplication. Quizartinib is associated with a high rate of liver enzyme elevations... | Quizartinib (kwiz ar’ ti nib) is an orally available small molecule inhibitor of the receptor tyrosine kinase FLT3 that is used in combination with other chemotherapeutic agents to treat patients with acute myelogenous leukemia (AML) who have mutations in FLT3. AML is the most common cause of acute leukemia in adults, ... | In the prelicensure clinical trials of quizartinib in patients with AML, ALT elevations were arose in 10% to 16% of patients and were above 5 times the upper limit of normal (ULN) in 1% to 3%. However, similar rates were reported in subjects receiving chemotherapy without quizartinib and in most instances the elevation... | The cause of serum aminotransferase elevations from quizartinib is unknown. Quizartinib is metabolized by the cytochrome P450 system, predominantly by CYP 3A4 and is susceptible to drug-drug interactions with inducers or inhibitors of the drug metabolizing enzyme which are best avoided during chemotherapy with its use. | The product label for quizartinib does not recommend routine monitoring of liver laboratory tests during therapy. Serum aminotransferase elevations above 5 times the upper limit of normal (if detected) should lead a search for alternative causes of liver enzyme elevations and, if none are found, to dose reduction or te... | Quizartinib – Vanflyta® | Antineoplastic Agents | null |
Minocycline.nxml | Minocycline | 2019-01-23 | Minocycline is a tetracycline antibiotic with excellent absorption and tissue penetration that is used for several bacterial infections as well as treatment of acne. Minocycline can cause both an acute hepatitis-like syndrome occurring within 1 to 3 months of starting therapy or a more insidious chronic hepatitis with ... | Minocycline (min" oh sye' kleen) is a semisynthetic derivative of tetracycline that has excellent oral absorption and wide tissue penetration. Like other tetracyclines, minocycline is believed to act by binding to bacterial ribosomes and inhibiting protein synthesis. Minocycline has a broad spectrum of activity against... | Minocycline therapy is associated with two forms of clinically apparent liver injury, an acute hepatitis-like syndrome that arises within 1 to 3 months of starting therapy and a chronic hepatitis-like syndrome typically with autoimmune features that occurs with long term therapy, sometimes after several years of use. T... | The cause of the liver injury associated with minocycline use is probably immunological, mediated by autoimmune reactions against liver cells or minocycline adducts present in the liver. Patients with minocycline induced liver injury have been reported to have an increased frequency of the rare HLA alelle B*35:02, but ... | The acute liver injury attributed to minocycline is usually self-limited in course, although fatal examples have been reported. In addition, the autoimmune hepatitis like syndrome caused by minocycline can be severe, and fatal outcomes have been described. Most cases, however, resolve slowly with withdrawal of the agen... | Minocycline – Generic, Dynacin®, Minocin® | Antiinfective Agents | [
{
"cas_registry_number": "13614-98-7",
"molecular_formula": "C23-H27-N3-O7.Cl-H",
"name": "Minocycline Hydrochloride"
},
{
"cas_registry_number": "17086-28-1",
"molecular_formula": "C22-H24-N2-O8.H2-O",
"name": "Doxycycline Monohydrate"
}
] |
Rotigotine.nxml | Rotigotine | 2017-07-21 | Rotigotine is a non-ergot dopamine receptor agonist used in the therapy of Parkinson disease and restless leg syndrome. Administered as a once daily transdermal patch, rotigotine has not been associated with serum enzyme elevations during treatment or with episodes of clinically apparent liver injury. | Rotigotine (roe tig' oh teen) is a synthetic dopamine agonist that is used to treat Parkinson disease and restless leg syndrome. Rotigotine is a nonselective agonist of dopamine receptors with highest affinity for the D3 class of receptors. It is structurally unrelated to ergot derivatives. Rotigotine is formulated as ... | In multiple, controlled trials in Parkinson disease and restless leg syndrome, rotigotine transdermal patches were not associated with serum enzyme elevations, liver related severe adverse events or instances of clinically apparent liver injury. Since the approval and more wide scale use of rotigotine, there have been ... | null | null | Rotigotine – Neupro® | Antiparkinson Agents | null |
Lixisenatide.nxml | Lixisenatide | 2019-04-10 | Lixisenatide is a recombinant DNA produced polypeptide analogue of human glucagon-like peptide-1 (GLP-1) which is used in combination with diet and exercise in the therapy of type 2 diabetes, either alone or in combination with other antidiabetic agents. Therapy with lixisenatide has not been associated with serum enzy... | Lixisenatide (lix" i sen' a tide) is a glucagon-like peptide-1 (GLP-1) analogue (also called a GLP-1 receptor agonist) that acts like the native gastrointestinal hormone (incretin) to increase insulin secretion. Lixisenatide, like other GLP-1 analogues, also suppress glucagon production and slows gastric emptying, feat... | In large clinical trials, serum enzyme elevations were no more common with lixisenatide therapy than with placebo or comparator agents. In pooled safety analyses of more than 5000 patients, ALT elevations above 3 times the upper limit of normal occurred in 0.6% of both lixisenatide and placebo groups and no instances o... | Lixisenatide is a polypeptide and is metabolized to amino acids by serum and tissue proteases, and is unlikely to have any direct hepatotoxic potential. Lixisenatide acts through the incretin pathway to affect glucose metabolism and, thus, is often grouped with other incretin based antidiabetic mediations such as the D... | null | Lixisenatide – Adlyxin® | Antidiabetic Agents | null |
CovidVaccines.nxml | Covid-19 Vaccines | 2021-10-28 | The Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2) is the cause of the pandemic of coronavirus disease (COVID-19) that was first detected in December 2019 in Wuhan, China and subsequently spread globally. By March 2020, COVID-19 was declared a global pandemic and within a year it accounted for more t... | In December 2019, a cluster of cases of severe pneumonia of unknown cause was reported from Wuhan, China that was rapidly shown to be due to a novel coronavirus – the Severe Acute Respiratory Syndrome Corona Virus type 2 (SARS-CoV-2), a virus distantly related to the SARS-CoV [1] agent that caused an epidemic of severe... | null | The mechanism(s) by which COVID-19 vaccines might cause serum enzyme elevations or clinically apparent liver injury is not known. The breakdown of mRNA and recombinant proteins occurs intracellularly and results in the release of polypeptides, amino acids and nucleic acids none of which should cause hepatic injury. In ... | Patients who receive COVID-19 vaccines should be encouraged to report any new major symptoms or signs that arise within a month after vaccination. Patients who receive adenoviral vectored vaccines should be informed of the possibility of thrombotic events arising 5 to 16 days after administration (usually with the firs... | BNT162b2 – Comirnaty® | Antiviral Vaccines | null |
Cyclophosphamide.nxml | Cyclophosphamide | 2017-11-05 | Cyclophosphamide is an alkylating agent used in the treatment of several forms of cancer including leukemias, lymphomas and breast cancer. Cyclophosphamide therapy is associated with minor transient serum enzyme elevations and has been linked to rare cases of acute liver injury. In addition, when given in high doses as... | Cyclophosphamide (sye" kloe fos' fa mide) is a synthetic, nitrogen mustard-like alkylating agent that is widely used in the therapy of cancer and in severe forms of autoimmune disease. It requires activation in the liver to form its active intermediaries which act by modifying and cross linking purine bases in DNA, thu... | Mild and transient elevations in serum aminotransferase levels are found in up to 43% of patients with cancer who are treated with cyclophosphamide. The abnormalities are generally asymptomatic and transient and do not require dose modification. Enzyme elevations are more common with higher doses and with intravenous t... | The cause of idiosyncratic hepatotoxicity from cyclophosphamide is not known. The sinusoidal obstruction syndrome induced by cyclophosphamide is probably related to the direct toxic effect of cyclophosphamide on sinusoidal cells in the liver, causing their necrosis and release into the sinusoids, obstruction and oblite... | The severity of liver injury attributed to cyclophosphamide ranges from mild elevations in liver enzymes to acute liver injury or to massive, fatal hepatic necrosis due to sinusoidal obstruction syndrome. There is currently no specific therapy for the idiosyncratic liver injury due to cyclophosphamide or for veno-occlu... | Cyclophosphamide – Cytoxan® | Antineoplastic Agents, Alkylating Agents | null |
StingingNettle.nxml | Stinging Nettle | 2023-03-03 | Stinging Nettle is an extract of either the leaves and flowering parts or the roots of Urtica dioica, a tall herbaceous plant found throughout the world in temperate and humid areas. Extracts of the leaves of stinging nettle are use in foods and animal feed and are purported to be beneficial for many conditions. Extrac... | Stinging nettle (also simply called nettle or stinger) is derived from the plant Urtica dioica, a tall herbaceous weed found in temperate and humid areas throughout the world. Stinging nettle is so named because contact with fresh leaves can cause a transient stinging skin rash, the result of histamine, acetyl choline ... | In multiple short- and long-term clinical trials of different preparations of stinging nettle extracts, adverse side effects were described as uncommon and minimal with no mention of either hepatotoxicity or ALT elevations. Few prospective studies included monitoring of liver tests, but those that did reported no chang... | The mechanism by which stinging nettle might cause liver injury is unknown. | Hepatotoxicity from extracts of stinging nettle roots, leaves and flowering parts has not been reported.\n\nDrug Class: Herbal and Dietary Supplements\n\nOther names: Nettle, Common Nettle, Stinger, Bichu, Ortie, Urtica. | Stinging Nettle – Generic | Herbal and Dietary Supplements | null |
Ripretinib.nxml | Ripretinib | 2023-10-12 | Ripretinib is a multikinase inhibitor that is used to treat refractory forms of advanced gastrointestinal stromal tumors. Serum aminotransferase elevations occur in a small proportion of patients treated with ripretinib, but episodes of clinically apparent liver injury with jaundice have not been reported with its use. | Ripretinib (rip re’ tin ib) is an orally available multikinase inhibitor that targets the proto-oncogene KIT and platelet derived growth factor receptor alpha (PDGFRA) and is used to treat patients with advanced and refractory gastrointestinal stromal tumors (GIST) after failure of other therapies. GIST is a rare mesen... | In the prelicensure placebo-controlled clinical trial in patients with refractory and extensively treated GIST, ALT elevations arose in 13% of ripretinib- vs 5% of placebo-treated subjects. ALT elevations were generally transient and mild, and were above 5 times the ULN in only 1% of treated patients and did not requir... | The possible cause of liver injury from ripretinib therapy is unknown. While serum bilirubin elevations occurred in more than 20% of patients in preregistration trials, the timing, duration and degree of elevations and whether conjugated or unconjugated were not described. Ripretinib is metabolized in the liver via the... | The product label for ripretinib does not recommend routine monitoring of liver laboratory tests during therapy. Serum aminotransferase elevations above 5 times the upper limit of normal (if detected) should lead to dose reduction or temporary cessation of treatment with careful monitoring if restarted after resolution... | Ripretinib – Qinlock® | Antineoplastic Agents | null |
Ibuprofen.nxml | Ibuprofen | 2018-04-16 | Ibuprofen is a commonly used nonsteroidal antiinflammatory (NSAID) drug which is available both by prescription and over-the-counter. Ibuprofen is considered to be among the safest NSAIDs and is generally well tolerated but can, nevertheless, rarely cause clinically apparent and serious acute liver injury. | Ibuprofen (eye" bue proe' fen) is a propionic acid NSAID similar to ketoprofen and naproxen. Like other NSAIDs, ibuprofen is a potent inhibitor of cellular cyclooxygenases (Cox-1 and Cox-2) which blocks the formation of prostaglandin, prostacyclin and thromboxane products, important mediators of inflammation and pain. ... | Rates of serum aminotransferase elevations during low dose, chronic ibuprofen therapy are comparable to those that occur with placebo controls (0.4%). However, higher rates of ALT elevations occur with high, full doses of 2,400 to 3,200 mg daily (up to 16%). Generally, ALT elevations are mild and rarely above 100 U/L. ... | The mechanism of ibuprofen induced liver injury is not completely known, but may be multi-factorial. The rapid onset suggests a toxic metabolic byproduct, while the hypersensitivity responses that accompany the liver injury point to an immuno-allergic reaction. | The severity of the liver injury from ibuprofen ranges from asymptomatic elevations in serum aminotransferase levels to acute cholestatic hepatitis to acute liver failure and the need for transplantation. Several instances of chronic vanishing bile duct syndrome have been attributed to ibuprofen use. In most instances,... | Ibuprofen – Generic, Motrin® | Nonsteroidal Antiinflammatory Drugs | null |
Benztropine.nxml | Benztropine | 2017-07-20 | Benztropine is an anticholinergic agent used predominantly in the symptomatic therapy of Parkinson disease and movement disorders. Benztropine has not been associated with serum enzyme elevations during treatment and has not been linked to cases of clinically apparent acute liver injury. | Benztropine (benz' troe peen) is an anticholinergic agent that blocks the central cholinergic receptors helping to balance cholinergic transmission in the basal ganglia. Benztropine may also block dopamine reuptake and storage in central sites thus increasing dopaminergic activity. The exact mechanism(s) by which the a... | Benztropine has not been reported to cause serum aminotransferase elevations, but it has not been evaluated for effects on serum enzyme levels in a prospective manner. Despite its use for more than 50 years, there have been no reports of benztropine liver injury in the literature and it must be a very rare cause of liv... | null | null | Benztropine – Generic, Cogentin® | Antiparkinson Agents | null |
Phenytoin.nxml | Phenytoin | 2020-07-30 | Phenytoin, formerly known as diphenylhydantoin, is a potent anticonvulsant used to treat and prevent generalized grand mal seizures, complex partial seizures and status epilepticus. Phenytoin was formerly the most commonly used anticonvulsant agent but is now declining in use, having been replaced by more modern, bette... | Phenytoin (fen' i toyn) is a hydantoin derivative that has potent anti-seizure activity that is believed to be based upon stabilization of neuronal membranes caused by an increase in the efflux and decrease in the influx of sodium ions across GABA regulated sodium channels. A similar action in cardiac muscle may accoun... | Prospective studies indicate that a fairly high proportion of patients taking phenytoin have transient serum aminotransferase elevations. These elevations are usually benign, not associated with liver histological abnormalities and usually resolve even with drug continuation. In addition, a higher proportion of patient... | The liver injury caused by phenytoin appears to be due to a hypersensitivity reaction and resembles typical cases of immunoallergic hepatotoxicity. This syndrome is more common in blacks than whites, but few other risk factors have been established. In some populations, the risk of injury correlates with the presence o... | Acute phenytoin hepatitis with jaundice has a fatality rate of greater than 10%. For this reason, phenytoin should be stopped promptly if symptoms of liver disease or jaundice arise early during therapy. Monitoring of ALT levels during introduction of phenytoin is recommended by some expert groups, but minor ALT elevat... | Phenytoin – Generic, Dilantin® | Anticonvulsants | null |
Fezolinetant.nxml | Fezolinetant | 2024-10-10 | Fezolinetant is an orally available neurokinin 3 receptor antagonist that is used to treat women with vasomotor symptoms (such as hot flashes) due to menopause. Fezolinetant is associated with a low rate of serum aminotransferase elevations during therapy and has been linked to rare instances of clinically apparent liv... | Fezolinetant (fez oh’ lin eh tant) is a neurokinin 3 (NK3) receptor antagonist that is used to treat moderate-to-severe vasomotor symptoms due to menopause. The neurokinin 3 receptor is found on neurons in the thermoregulatory center of the brain, is activated by binding to neurokinin B, and is inhibited by circulating... | In preregistration clinical trials, serum ALT or AST elevations above 3 times the upper limit of normal (ULN) occurred in 2.3% of patients taking fezolinetant vs 0.9% of placebo recipients. The elevations were largely asymptomatic and transient, resolving promptly after stopping therapy and sometimes despite drug conti... | null | The product label for fezolinetant has a warning about drug induced liver injury and recommends assessing symptoms and laboratory features of liver disease before starting therapy and monitoring routine liver tests thereafter monthly for 3 months, again at 6 and 9 months, thereafter if signs of symptoms of liver injury... | Fezolinetant – Veozah® | Obstetrical and Gynecological Agents | null |
Clobazam.nxml | Clobazam | 2017-01-25 | Clobazam is a benzodiazepine that is used as an anticonvulsant in the therapy of severe childhood epilepsy. Therapy with clobazam has not been associated with serum aminotransferase elevations, and clinically apparent liver injury from clobazam has yet to be reported and must be rare, if it occurs at all. | Clobazam (kloe' ba zam) is a unique 1,5 benzodiazepine which is used in the United States as an anticonvulsant, but is available in other countries for therapy of anxiety as well as epilepsy. The anticonvulsant activity of clobazam appears to be mediated by its ability to enhance gamma-aminobutyric acid (GABA) medicate... | Limited data are available on the hepatotoxicity of clobazam. In clinical trials, clobazam was not associated with an increased frequency of serum aminotransferase elevations as compared to placebo treatment, and there were no instances of clinically apparent liver injury. No individual case reports of clobazam hepatot... | Clobazam is extensively metabolized by the liver, largely by glucuronidation and acetylation. Its metabolism is independent of the microsomal P450 system, and it has little or no effect on P450 activity and lacks significant drug-drug interactions. | There is no information on the possible cross sensitivity to hepatotoxicity among the various benzodiazepines used as anticonvulsants such as diazepam, clonazepam, clorazepate or clobazam. Nevertheless, switching from one to another after clinically apparent liver injury should be done with caution and with appropriate... | Clobazam – Onfi® | Anticonvulsants | [
{
"cas_registry_number": "22316-47-8",
"molecular_formula": "C16-H13-Cl-N2-O2",
"name": "Clobazam"
},
{
"cas_registry_number": "1622-61-3",
"molecular_formula": "C15-H10-Cl-N3-O3",
"name": "Clonazepam"
},
{
"cas_registry_number": "57109-90-7",
"molecular_formula": "C16-H10-Cl... |
Fulvestrant.nxml | Fulvestrant | 2018-02-06 | Fulvestrant is a steroidal antiestrogen that is used in the treatment of hormone-receptor positive metastatic breast cancer. Fulvestrant therapy can be associated with serum enzyme elevations, but has yet to be linked to instances of clinically apparent acute liver injury in the published literature. | Fulvestrant (ful ves' trant) is a steroidal antiestrogen that is potent and direct antagonist or "down regulator" of the estrogen receptor. Fulvestrant is a synthetic derivative of estradiol and binds to the estrogen receptor with 100 times more potency than tamoxifen. It not only blocks the effects of estrogen, but al... | Fulvestrant therapy is said to be associated with serum enzyme elevations in up to 15% of patients, but the elevations are generally asymptomatic, transient and mild, rarely requiring dose adjustment or discontinuation. ALT elevations above 5 times the upper limit of normal occurred in only 1% to 2% of patients. Howeve... | Fulvestrant is extensively metabolized in the liver, largely via the cytochrome P450 enzyme CYP 3A4, but has not been found to have significant drug-drug interactions. Nevertheless, hepatotoxicity might be caused by a toxic or immunogenic metabolic product of fulvestrant. | While fulvestrant has been reported to cause serum enzyme elevations during therapy, it has not been convincing linked to cases of clinically apparent liver injury, acute liver failure, chronic hepatitis, fatty liver or vanishing bile duct syndrome. There is no reason to suspect that there is cross sensitivity to liver... | Fulvestrant – Generic, Faslode® | Antineoplastic Agents | [
{
"cas_registry_number": "129453-61-8",
"molecular_formula": "C32-H47-F5-O3-S",
"name": "Fulvestrant"
},
{
"cas_registry_number": "50-28-2",
"molecular_formula": "C18-H24-O2",
"name": "Estradiol(17-β)"
}
] |
Mobocertinib.nxml | Mobocertinib | 2023-10-30 | Mobocertinib is an oral tyrosine kinase receptor inhibitor that targets the epidermal growth factor receptor (EGFR) and was given accelerated approved for use in refractory, advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations in 2021, but was subsequently withdrawn from use in Octobe... | Mobocertinib (moe” boe cer’ ti nib) is an orally available tyrosine kinase inhibitor that targets both wild type and mutant forms of the epidermal growth factor receptor (EGFR), which are found in patients with highly treated, resistant forms of advanced or metastatic cancer such as non-small cell lung cancer (NSCLC). ... | In the prelicensure clinical trials of mobocertinib in patients with NSCLC harboring the exon 20 insertion mutation in EGRF, ALT elevations arose in 22% of patients but were usually self-limited and mild. ALT elevations above 5 times the upper limit of normal (ULN) were uncommon, being found in 2% to 3% of treated pati... | The cause of serum aminotransferase elevations from mobocertinib is unknown, but the pattern of abnormalities suggests some degree of direct toxicity. Mobocertinib is metabolized in the liver via the cytochrome P450 system, largely CYP 3A4, and is susceptible to drug-drug interactions with agents that inhibit or induce... | The product label for mobocertinib does not recommend regular monitoring of liver tests, but if serum aminotransferase levels above 5 times the ULN are identified, therapy should be held until levels fall into the normal or near normal range, at which point therapy can be resumed at the same or a reduced dose as clinic... | Mobocertinib – Exkivity® | Antineoplastic Agents | null |
Clomipramine.nxml | Clomipramine | 2017-10-15 | Clomipramine is a tricyclic antidepressant used in the therapy of obsessive-compulsive disorder. Clomipramine can cause mild and transient serum enzyme elevations and is rare cause of clinically apparent acute liver injury. | Clomipramine (kloe mip' ra meen) is a dibenzazepine derived tricyclic antidepressant which acts by inhibition of serotonin reuptake within synaptic clefts in the central nervous system, thus increasing brain serotonin levels. Clomipramine also has some blocking activity at postsynaptic dopamine receptors. Clomipramine ... | Liver test abnormalities have been reported to occur in up to 16% of patients being treated with tricyclic antidepressants, but elevations are uncommonly above 3 times the upper limit of normal. Serum aminotransferase elevations during clomipramine therapy are reported in 1% to 3% of patients and the abnormalities were... | The mechanism by which clomipramine causes serum aminotransferase elevation is not known. It undergoes extensive hepatic metabolism and a possible cause of liver injury is production of a toxic intermediate of metabolism that may be directly toxic or may induce a hypersensitivity reaction. | The serum aminotransferase elevations that occur on clomipramine therapy are usually self-limited and do not require dose modification or discontinuation of therapy. The acute liver injury caused by clomipramine is typically self-limited and benign. Results of rechallenge after acute liver injury from clomipramine has ... | Clomipramine – Anafranil® | Antidepressant Agents | null |
Phenotypes_auto.nxml | Autoimmune Hepatitis | 2019-05-04 | null | null | null | null | null | null | null | null |
Tacrolimus.nxml | Tacrolimus | 2020-02-17 | Tacrolimus is a calcineurin inhibitor and potent immunosuppressive agent used largely as a means of prophylaxis against cellular rejection after transplantation. Tacrolimus therapy can be associated with mild serum enzyme elevations, and it has been linked to rare instances of clinically apparent cholestatic liver inju... | Tacrolimus (ta kroe' li mas), also previously known as FK506, is a macrolide antibiotic which also has profound immunosuppressive properties, particularly affecting T cells and the cellular immune response. Tacrolimus acts as a calcineurin inhibitor which is responsible for activating an important signal transduction m... | Tacrolimus therapy is associated with mild to moderate elevations in serum aminotransferase levels in 5% to 10% of patients. These elevations are usually mild, asymptomatic and self-limited, but are occasionally persistent and may require dose modification. Tacrolimus has also been implicated in instances of cholestati... | Tacrolimus undergoes extensive hepatic metabolism largely via the cytochrome P450 system (CYP 3A4) and is susceptible to many drug-drug interactions. Liver test abnormalities during therapy may be due to direct hepatotoxicity, its effects on levels of other medications, or its effects on the immune system. | The liver injury due to tacrolimus is usually mild and self-limiting and responses rapidly to dose adjustment or drug discontinuation. Other calcineurin inhibitors and immunosuppressants are generally tolerated, but rare instances of cross sensitivity to hepatic injury by cyclosporine and tacrolimus have been reported.... | Tacrolimus – Generic, Prograf® | Transplant Agents | null |
Indinavir.nxml | Indinavir | 2017-09-01 | Indinavir is an antiretroviral protease inhibitor used in the therapy and prevention of human immunodeficiency virus (HIV) infection and the acquired immunodeficiency syndrome (AIDS). Indinavir can cause transient and usually asymptomatic elevations in serum aminotransferase levels and mild elevations in indirect bilir... | Indinavir (in din' a vir) is an antiretroviral protease inhibitor that acts by binding to the catalytic site of the HIV protease, thereby preventing the cleavage of viral polyprotein precursors into mature, functional proteins that are necessary for viral replication. Indinavir was approved for use in the United States... | Some degree of serum aminotransferase elevations occur in a high proportion of patients taking indinavir containing antiretroviral regimens. Moderate-to severe elevations in serum aminotransferase levels (>5 times the upper limit of normal) are found in 3% to 10% of patients, although rates may be higher in patients wi... | The cause of the clinical hepatotoxicity from indinavir is only partially known. The indirect hyperbilirubinemia associated with indinavir use is caused by inhibition of hepatic conjugation of bilirubin, similar to what occurs in Gilbert syndrome and is not indicative of liver injury. Indinavir is extensively metaboliz... | The severity of the liver injury from indinavir ranges from mild and transient enzyme elevations to more marked and symptomatic liver test abnormalities and, rarely, to acute hepatitis. Hepatic injury from indinavir is usually self-limited, but instances of acute liver failure and death have been reported. In the typic... | Indinavir – Crixivan® | Antiviral Agents | null |
Rimantadine.nxml | Rimantadine | 2020-06-10 | Rimantadine is an antiviral agent used as therapy for influenza A. Rimantadine has not been associated with clinically apparent liver injury. | Rimantadine (ri man' ta deen) is a cyclic primary amine that has antiviral and anti-Parkinsonian activities. The antiviral activity of rimantadine is attributed to inhibition of virion uncoating and release of viral RNA in the initial stages of viral replication. Rimantadine is active only against influenza A virus and... | Despite widespread use, there is little evidence that rimantadine when given orally causes liver injury, either in the form of serum enzyme elevations or clinically apparent liver disease.\n\nLikelihood score: E (unlikely cause of clinically apparent liver injury). | Rimantadine has minimal hepatic metabolism and is excreted largely unchanged in the urine, factors which perhaps explain the absence of significant hepatotoxicity.\n\nDrug Class: Antiviral Agents\n\nOther Drugs in the Class for Influenza: Amantadine, Baloxavir, Oseltamivir, Peramivir, Zanamivir | null | Rimantadine – Generic, Flumadine® | Antiviral Agents | null |
Niacin.nxml | Niacin | 2020-07-09 | Niacin, also known as nicotinic acid and vitamin B3, is a water soluble, essential B vitamin that, when given in high doses, is effective in lowering low density lipoprotein (LDL) cholesterol and raising high density lipoprotein (HDL) cholesterol, which makes this agent of unique value in the therapy of dyslipidemia. N... | Niacin (nye" a sin) is a soluble B vitamin and pyridine derivative and an essential dietary element, deficiency of which causes pellagra. The recommended dietary allowance (RDA) of this vitamin is 14 to 16 mg daily in adults, and slightly more for pregnant women (18 mg) and less for children (2 to 12 mg). Niacin given ... | Niacin in doses above 500 mg daily causes transient, asymptomatic elevations in serum aminotransferase levels in up to 20% of people. The elevations are rarely greater than 3 times the upper limit of the normal range and usually resolve spontaneously even with continuation of the drug. The effect is partially dose rela... | The mechanism of hepatotoxicity is assumed to be an intrinsic toxic reaction related to high serum levels of niacin that overwhelm the high affinity, low concentration nicotinic acid receptors (that are responsible for the flushing response). The finding that niacin can be restarted at lower doses after an episode of c... | Niacin hepatotoxicity appears to be dose dependent and more common with the sustained release form of the drug. Hepatotoxicity is less common with regular, crystalline niacin or extended release niacin. Most cases are mild and resolve rapidly upon stopping the medication, although in some instances, the injury is acute... | Niacin – Generic, Niacor®, Niaspan® | Antilipemic Agents; Vitamins | null |
Letermovir.nxml | Letermovir | 2019-04-10 | Letermovir is an antiviral agent which targets the DNA terminal transferase complex of the cytomegalovirus (CMV) and which is used to prevent CMV reactivation in immunocompromised patients. Letermovir has been associated with mild-to-moderate serum aminotransferase elevations during therapy but has not been linked to c... | Letermovir (le term' oh vir) is a potent inhibitor of the cytomegalovirus (CMV) DNA terminal transferase complex which is needed for the processing and packaging of the viral DNA and formation of mature virions. Letermovir is unique in targeting the DNA terminal transferase complex, whereas other antivirals used in the... | In large preregistration clinical trials, ALT elevations occurred in 18.5% of letermovir vs 21.9% of placebo recipients after hematopoietic cell transplantation, and levels rose to above 5 times ULN in 3.5% vs 1.6%. The ALT elevations were generally transient, mild and asymptomatic. Recurrence of serum ALT elevations o... | The absence of hepatotoxicity from letermovir is probably related to the fact that it has minimal hepatic metabolism. Letermovir is taken up by the liver via OATP1B1/3, a major hepatic plasma membrane organic anion transporter and its major route of excretion is biliary. Letermovir appears to have only mild effects on ... | The minor aminotransferase elevations associated with letermovir therapy are usually self-limited and rarely require dose modification or discontinuation of therapy. In patients who develop ALT or AST elevations above 5 times ULN during therapy, letermovir should be at least temporarily discontinued and restarted only ... | Letermovir – Prevymis® | Antiviral Agents | null |
Cytarabine.nxml | Cytarabine | 2017-11-03 | Cytarabine is a cytosine analogue and antineoplastic agent used largely in the therapy of acute leukemia. Cytarabine is associated with a low rate of transient serum enzyme and bilirubin elevations during therapy, but has only rarely been implicated in cases of clinically apparent acute liver injury with jaundice. | Cytarabine (sye tar' a been) is an nucleoside analogue (cytosine arabinoside: ara-C) which is converted intracellularly to a triphosphate, which competes with cytosine triphosphate for incorporation into RNA and DNA and acts as an inhibitor of RNA and DNA polymerase, thus blocking DNA synthesis and cell division. Cytar... | Serum aminotransferase elevations occur in 5% to 10% of patients on conventional doses of cytarabine and a greater proportion (9% to 75%) at higher doses. However, the serum enzyme elevations are rarely associated with symptoms and are generally self-limited and resolve rapidly, rarely requiring dose modification. Case... | While hepatotoxicity from cytarabine may be rare, it is likely due to direct toxicity to hepatocytes. Cytarabine is metabolized in the liver via the cytochrome P450 system and production of a toxic or immunogenic intermediate may trigger liver injury. | The severity of the liver injury linked to cytarabine therapy is usually mild and self-limited. Cytarabine has been linked to cases of acute liver failure but the relationship to cytarabine has not always been clear. Cytarabine has not been linked chronic hepatitis or vanishing bile duct syndrome. The product label for... | Cytarabine – Generic, Cytosar-U®, DepoCyt® | Antineoplastic Agents | null |
Ocrelizumab.nxml | Ocrelizumab | 2019-12-16 | Ocrelizumab is a humanized monoclonal antibody to CD20 which is used as therapy of multiple sclerosis. Ocrelizumab has not been associated with serum enzyme elevations during therapy nor with instances of idiosyncratic liver injury, but has been linked to cases of reactivation of hepatitis B in susceptible patients. | Ocrelizumab (ok" re liz' ue mab) is a humanized IgG1 monoclonal antibody to CD20, a cell surface antigen found on pre-B cells, mature B cells and memory B cells. Engagement of CD20 causes cell lysis resulting in B cell depletion which may be beneficial in autoimmune conditions mediated by autoantibodies. Ocrelizumab li... | Mild-to-moderate serum aminotransferase elevations were reported to occur in 1% to 2% of patients during ocrelizumab therapy. The elevations, however, were self-limited and resolved even with continuing cyclic therapy and were no more frequent than occurred with placebo. Neither during premarketing evaluation nor subse... | null | Guidelines for management of patients who are to receive ocrelizumab recommend routine screening for hepatitis B before starting treatment. Screening should include tests for HBsAg and anti-HBc (and perhaps also anti-HBs as this may help in management). Prophylaxis with a potent oral, antiviral agent effective against ... | Ocrelizumab – Ocrevus® | Multiple Sclerosis Agents | null |
Semaglutide.nxml | Semaglutide | 2019-04-10 | Semaglutide is a recombinant DNA produced polypeptide analogue of human glucagon-like peptide-1 (GLP-1) which is used in combination with diet and exercise in the therapy of type 2 diabetes, either alone or in combination with other antidiabetic agents. There have been no published reports of hepatotoxicity attributed ... | Semaglutide (sem" a gloo' tide) is a glucagon-like peptide-1 (GLP-1) analogue (also called a GLP-1 receptor agonist) that acts like the native gastrointestinal hormone (incretin) to increase insulin secretion. Semaglutide reproduces the activity of GLP-1, binding to specific receptors on pancreatic beta cells and incre... | In large clinical trials, serum enzyme elevations were no more common with semaglutide therapy than with placebo or comparator agents, and no instances of clinically apparent liver injury were reported. Indeed, treatment with semaglutide and other GLP-1 analogues is often associated with improvements in serum aminotran... | Semaglutide is a polypeptide and is metabolized to amino acids by serum and tissue proteases and is unlikely to have any direct hepatotoxic potential. Semaglutide acts through the incretin pathway to affect glucose metabolism and, thus, is often grouped with other incretin-based antidiabetic mediations such as the DPP-... | null | Semaglutide – Ozempic® | Antidiabetic Agents | null |
Oseltamivir.nxml | Oseltamivir | 2020-06-22 | Oseltamivir is an inhibitor of the influenza neuraminidase enzyme and is used as therapy and prophylaxis against influenza A and B. Oseltamivir has not been associated with clinically apparent liver injury. | Oseltamivir (oh" sel tam' i vir) phosphate is an ester prodrug of an antiviral enzyme inhibitor which, after absorption, is converted in the liver to oseltamivir carboxylase, the active intermediate. Oseltamivir carboxylase is a potent inhibitor of the enzyme neuraminidase of the influenza virus particle. Inhibition of... | In clinical trials of oseltamivir, serum aminotransferase elevations occurred in 2% of treated subjects, but were asymptomatic and transient in all and there were no reports of clinically apparent liver injury with jaundice. The rates of ALT elevations with oseltamivir were generally similar to those treated with place... | Oseltamivir is metabolized by the liver to the active intermediate oseltamivir carboxylate, but has little further hepatic metabolism and is excreted largely in the urine. The rapid onset of liver injury attributed to oseltamivir in case reports and the occurrence of hypersensitivity reactions such as Stevens Johnson s... | null | Oseltamivir – Generic, Tamiflu® | Antiviral Agents | null |
Tofersen.nxml | Tofersen | 2025-03-12 | Tofersen is an antisense oligonucleoside directed against mutated forms of SOD1 used in the treatment of adults with amyotrophic lateral sclerosis with mutations in the SOD1 gene. Tofersen has been associated with minor liver test abnormalities during therapy but has not been linked instances of clinically apparent liv... | Tofersen (toe fer’ sin) is an antisense oligonucleoside that is directed against the mRNA of the mutated superoxide dismutase 1 (SOD1) gene and is used in the treatment of adults with amyotrophic lateral sclerosis with mutated SOD1. Amyotrophic lateral sclerosis (ALS) is a rare, but invariably fatal neuromuscular disea... | In the initial registration trial of tofersen in ALS, serum aminotransferase elevations above 3 times the upper limit of normal (ULN) occurred in 4% of treated patients, but the elevations were generally transient, mild, and no more frequent than in a placebo-treated patients (3%). With longer term, open label studies,... | The mechanism by which tofersen might cause liver injury is not clear. Tofersen is a short (20 mer) oligonucleotide and is metabolized to short sequences or individual nucleotides by tissue and plasma exonucleases. Tofersen is administered intrathecally, but low levels are found in serum. It is not metabolized by P450 ... | The serum aminotransferase elevations that occur on tofersen therapy are unlikely to be due to the drug therapy and rarely require dose modification or discontinuation. Persistent ALT or AST elevations arising during therapy should lead to evaluation of their possible causes. There is no information on cross sensitivit... | Tofersen – Qalsody® | Neurological Disease Agents | null |
Paclitaxel.nxml | Paclitaxel | 2020-09-07 | Paclitaxel is an antineoplastic agent which acts by inhibitor of cellular mitosis and which currently plays a central role in the therapy of ovarian, breast, and lung cancer. Therapy with paclitaxel has been associated with a low rate of serum enzyme elevations, but has not been clearly linked to cases of clinically ap... | Paclitaxel (pak" li tax' el) is a complex diterpenoid molecule that contains a central 8-member taxane ring. Paclitaxel was initially isolated from the bark of the Western Yew tree (Taxus breviflora) and found to have antitumor activity in high throughput assays. It is a potent antineoplastic agent and its mechanism of... | Paclitaxel has been associated with serum aminotransferase elevations in 7% to 26% of patients, but values greater than 5 times the upper limit of normal (ULN) in only 2% of those receiving the highest doses. Similar rates of alkaline phosphatase elevations and occasional mild bilirubin elevations also occur. The abnor... | The mild liver injury that arises during therapy is probably due to a direct effect of paclitaxel in inhibiting microtubular function. Paclitaxel is metabolized by the cytochrome P450 system, largely CYP 2C8 and to a lesser extent 3A4. The severe liver injury that accompanies infusion reactions to paclitaxel is likely ... | The serum aminotransferase elevations that occur on paclitaxel therapy are usually self-limited and do not require dose modification or discontinuation of therapy. Patients with an acute hypersensitivity reaction to paclitaxel should have the infusion stopped and not be reexposed to paclitaxel or to docetaxel, a closel... | Paclitaxel – Generic, Onxol®, Taxol® | Antineoplastic Agents | null |
Trihexyphenidyl.nxml | Trihexyphenidyl | 2017-07-20 | Trihexyphenidyl is an oral anticholinergic agent used predominantly in the symptomatic therapy of Parkinson disease and movement disorders. Trihexyphenidyl has not been associated with serum enzyme elevations during treatment, but has been implicated in rare cases of acute liver injury. | Trihexyphenidyl is an anticholinergic agent that blocks the central cholinergic receptors, helping to balance cholinergic transmission in the basal ganglia. Trihexyphenidyl may also block dopamine reuptake and storage in central sites thus increasing dopaminergic activity. The exact mechanism(s) by which the anticholin... | Trihexyphenidyl has not been reported to cause serum aminotransferase elevations, but it has not been evaluated for effects on serum enzyme levels in a prospective manner. Trihexyphenidyl was cited as the cause of two cases of acute liver injury resulting in death in the Japanese literature, but few details were given ... | The metabolism of trihexyphenidyl has not been well defined; it appears to be metabolized in the liver to a small extent.\n\nDrug Class: Antiparkinson Agents\n\nOther Drugs in the Subclass, Anticholinergic Agents: Benztropine, Biperiden | null | Trihexyphenidyl – Generic, Artane® | Antiparkinson Agents | null |
Bicalutamide.nxml | Bicalutamide | 2023-03-15 | Bicalutamide is a second generation, oral nonsteroidal antiandrogen similar in structure to flutamide that has been used widely in the therapy of prostate cancer. Bicalutamide is associated with a low rate of serum enzyme elevations during therapy and has been linked to rare instances of liver injury. | Bicalutamide (bye" ka loo' ta mide) is an orally available nonsteroidal antiandrogen that is similar in structure to flutamide and nilutamide used in the treatment of prostate cancer. Bicalutamide acts by binding to intracellular androgen receptors and competitively inhibiting the action of endogenous androgens on sens... | Bicalutamide therapy is associated with mild, asymptomatic and transient elevations in serum aminotransferase levels in approximately 6% of patients. The frequency and height of the ALT elevations appears to be less with bicalutamide than flutamide. Similarly, there have been rare case reports of clinically apparent li... | The mechanism of bicalutamide hepatotoxicity is unknown. It is metabolized by the liver via the cytochrome P450 system, largely via CYP 3A4 which it can inhibit and thus cause drug-drug interactions. Thus, liver injury from bicalutamide may be caused by toxic or immunogenic metabolites of the agent. The lower frequency... | The mild ALT elevations during bicalutamide therapy are usually self-limiting even with continuation of the medication. The rare instances of clinically apparent liver injury have ranged in severity from mild self-limiting cases to fatal acute liver failure. Monitoring of liver tests during therapy is recommended. Ther... | Bicalutamide – Generic, Casodex® | Antineoplastic Agents | null |
Anakinra.nxml | Anakinra | 2020-04-20 | Anakinra is a recombinant interleukin-1 (IL-1) receptor antagonist that has antiinflammatory and immunomodulatory actions and is used in the therapy of rheumatoid arthritis and other inflammatory arthritides. Anakinra is associated with a low rate of serum enzyme elevations during therapy and with rare instances of cli... | Anakinra (an a kin’ ra) is used to treat serious inflammatory conditions such as rheumatoid arthritis and cryopyrin-associated periodic syndromes (CAPS). IL-1 like tumor necrosis factor alpha (TNF) is a proinflammatory cytokine that plays a major role in the immune responses underlying local and systemic inflammation. ... | In large registration trials, ALT elevations occurred in <1% of patients taking anakinra, a rate not different from that in placebo recipients, and no cases of clinically apparent liver injury with jaundice were reported. Since its approval and more wide scale use, however, anakinra has been linked to several instances... | Anakinra binds to circulating IL-1 and is metabolized peripherally, probably largely in macrophages. It is a polypeptide and has minimal hepatic metabolism. The mechanism by which it causes liver injury is unknown, but may be the result of its effects on the immune system. | The hepatic injury caused by anakinra is usually self-limited and resolves within a few weeks of stopping the medication, although some cases have been severe and protracted. Cases of fatal, acute liver failure, chronic hepatitis and vanishing bile duct syndrome have not been reported with its use. There is no reason t... | Anakinra – Kineret® | Antirheumatic Agents | null |
Tositumomab.nxml | Tositumomab | 2020-04-15 | Tositumomab is the combination of a monoclonal antibody to CD20 and iodine-131 which is used to treat refractory, advanced non-Hodgkin lymphoma. Tositumomab has not been associated with significant serum enzyme elevations during therapy or to cases of idiosyncratic, clinically apparent liver injury. However, tositumoma... | Tositumomab (toe si tue’ moe mab) is a monoclonal antibody to the cell surface antigen CD20 (also known as human B lymphocyte restricted differentiation antigen: Bp35) which is found on mature B cells as well as 90% of neoplastic B cell such as occur in non-Hodgkin lymphoma. Engagement of tositumomab with CD20 leads to... | Serum aminotransferase elevations are uncommon during tositumomab therapy and rarely mentioned in large clinical trials of its use in non-Hodgkin lymphoma. Clinically apparent liver injury has not been reported with tositumomab therapy either in prelicensure clinical trials or subsequent to its general clinical use.\n\... | The mechanism of liver injury in reactivation of hepatitis B appears to be a brisk immunological response to newly expressed viral antigens on hepatocytes. Injury generally arises after immunosuppressive or cancer chemotherapy has stopped or between courses of treatment. | Guidelines for management of patients who are to receive tositumomab recommend routine screening for hepatitis B before starting treatment. Screening should include tests for HBsAg and anti-HBc (and perhaps also anti-HBs as this may help in management). Prophylaxis with a potent oral, antiviral agent effective against ... | Tositumomab – Bexxar® | Antineoplastic Agents | null |
Bortezomib.nxml | Bortezomib | 2017-09-30 | Bortezomib is a proteasome inhibitor and antineoplastic agent that is used in treatment of refractory multiple myeloma and certain lymphomas. Bortezomib is associated with a low rate of serum enzyme elevations during treatment and to rare instances of clinically apparent, acute liver injury. | Bortezomib (bor tez’ oh mib) is an orally available, small molecule inhibitor of the 26S proteasome, the intracellular complex that degrades proteins involved in cell signaling and cell cycle regulation. Blocking proteasome activity prevents activation of factors involved in cell growth and resistance to chemotherapy i... | In large clinical trials of bortezomib, elevations in serum aminotransferase levels were common, occurring in ~10% of patients. However, values greater than 5 times the upper limit of normal (ULN) were rare, occurring in <1% of recipients. Cases of clinically apparent liver injury including acute liver failure have bee... | The mechanisms of liver injury accounting for serum enzyme elevations and hepatic toxicity during bortezomib therapy are not known. Bortezomib is metabolized in the liver largely through the CYP 3A4 pathway and liver injury may be related to production of a toxic intermediate. Bortezomib is susceptible to drug-drug int... | Serum aminotransferase elevations above 5 times the upper limit of normal (if confirmed) should lead to dose reduction or temporary cessation. Clinically apparent liver injury should prompt immediate interruption of bortezomib therapy. Cases of hepatic failure attributed to bortezomib have been described, but no instan... | Bortezomib – Velcade® | Antineoplastic Agents | null |
Lenalidomide.nxml | Lenalidomide | 2022-08-30 | Lenalidomide is an immunomodulatory and antineoplastic agent that is used in the therapy of multiple myeloma. Lenalidomide is associated with a low rate of serum aminotransferase elevations during therapy and has been implicated in causing rare instances of clinically apparent liver injury which can be severe. | Lenalidomide (len" a lid' oh mide) is a thalidomide derivative that has similar but more potent activity as an antineoplastic agent. Thalidomide and its derivatives have immunomodulatory, antiinflammatory antiangiogenic and antineoplastic activities. The mechanism of action of these agents in the treatment of multiple ... | Serum enzyme elevations occur in 8% to 15% of patients taking lenalidomide and are more frequent with higher doses. The enzyme abnormalities are usually mild and self-limited, and only rarely require drug discontinuation. In addition, lenalidomide has been implicated in rare instances of clinically apparent, acute live... | The mechanism of lenalidomide hepatotoxicity is not clear, but it may be related to its activity in reducing TNF-α production, a potent inflammatory cytokine that activates T cells and promotes inflammation, but is also necessary for normal liver regeneration. Several of the reported cases of hepatotoxicity have occurr... | The severity of lenalidomide induced liver injury ranges from transient, asymptomatic elevations in serum enzymes to acute liver injury with jaundice to severe acute liver failure and death. The liver injury usually starts to resolve within a week of stopping the medication, but prolonged jaundice with bile duct injury... | null | Antineoplastic Agents | [
{
"cas_registry_number": "50-35-1",
"molecular_formula": "C13-H10-N2-O4",
"name": "Thalidomide"
},
{
"cas_registry_number": "191732-72-6",
"molecular_formula": "C13-H13-N3-O3",
"name": "Lenalidomide"
},
{
"cas_registry_number": "19171-19-8",
"molecular_formula": "C13-H11-N3-O... |
Metoclopramide.nxml | Metoclopramide | 2020-02-03 | Metoclopramide is an oral prokinetic and antiemetic agent used in the therapy of gastroesophageal reflux disease, gastroparesis and severe or chemotherapy induced nausea. Metoclopramide has been linked to rare instances of clinically apparent liver injury that are typically cholestatic and can be associated with bile d... | Metoclopramide is a benzamide (a para-aminobenzoic acid derivative) which acts as a prokinetic agent on the gastrointestinal tract and an antiemetic, particularly in persons with gastrointestinal dysmotility. Its mechanism of action is uncertain; it is a serotonin type 4 (5-HT4) receptor agonist, but also has antagonis... | Serum aminotransferase elevations during metoclopramide therapy are uncommon and rates of such elevations were not reported in the large clinical trials demonstrating its efficacy in motility disorders. Metoclopramide has been listed as a cause of clinically apparent liver injury in several large series of drug induced... | Metoclopramide has little active hepatic metabolism and is excreted largely unchanged in the urine. The clinically apparent liver disease attributed to metoclopramide is probably immune mediated. | Most instances of liver injury due to metoclopramide have been self-limiting and resolve upon withdrawal of the agent. A single instance of vanishing bile duct syndrome has been described. Little is known about cross sensitivity with other prokinetic medications.\n\nDrug Class: Gastrointestinal Agents, Antiemetics | Metoclopramide – Generic, Reglan® | Gastrointestinal Agents | null |
Tesamorelin.nxml | Tesamorelin | 2018-10-20 | Tesamorelin is a synthetic growth hormone releasing hormone analogue used in the treatment of visceral adiposity in human immunodeficiency virus (HIV) infected patients with lipodystrophy. Tesamorelin is given subcutaneously and has major effects on glucose and lipid metabolism, but has not been linked to serum aminotr... | Tesamorelin (tes" a moe rel' in) is a synthetic 44 amino acid polypeptide analogue of growth hormone releasing hormone (GHRH). The N terminal portion of the molecule has been modified to improve its stability and pharmacokinetics in comparison to native GHRH. Tesamorelin activates GHRH receptors in the pituitary which ... | In clinical trials in patients with HIV-associated lipodystrophy, tesamorelin therapy was not associated with de novo elevations in serum enzymes and, in some studies, was associated with decreases in preexisting ALT elevations, possibly mediated by improvements in nonalcoholic fatty liver. Instances of clinically appa... | Tesamorelin is a synthetic polypeptide that acts upon growth hormone producing cells in the pituitary and is generally metabolized locally by the receptor bearing cells. As a polypeptide, tesamorelin is unlikely to have direct cytotoxicity. Allergic responses to its administration have not caused hepatic or systemic hy... | null | Tesamorelin – Egrifta Depot® | Hormonal Agents | null |
Tiagabine.nxml | Tiagabine | 2018-02-19 | Tiagabine is a unique anticonvulsant used largely as an adjunctive agent in therapy of partial seizures in adults or children. Therapy with tiagabine is not associated with serum aminotransferase elevations, and clinically apparent liver injury from tiagabine has not been reported and must be rare if it occurs at all. | Tiagabine (tye ag' a been) is a selective gamma aminobutyric acid (GABA) reuptake inhibitor that increases synactive concentrations of this major neuroinhibitory transmitter, thus decreasing spread of abnormal neuronal impulses that contribute to seizures. Tiagabine has been shown to be effective both as monotherapy an... | Limited data are available on the hepatotoxicity of tiagabine. In clinical trials, therapy with tiagabine was not associated with an increased frequency of serum aminotransferase elevations or liver toxicity. No individual case reports of liver injury from tiagabine have been published and its use has not been associat... | The apparent absence of significant hepatotoxicity from tiagabine is despite the fact that it is metabolized by the liver and interacts with the CYP 450 system.\n\nDrug Class: Anticonvulsants | null | Tiagabine – Generic, Gabitril® | Anticonvulsants | null |
Tepotinib.nxml | Tepotinib | 2023-09-08 | Tepotinib is an orally available, small molecule inhibitor of the mesenchymal-epithelial transition (MET) factor tyrosine kinase receptor that is used to treat selected cases of non-small cell lung cancer (NSCLC). Serum aminotransferase elevations are common during therapy with tepotinib, but it has not been linked to ... | Tepotinib (tep oh’ ti nib) is an orally available, small molecule inhibitor of the mesenchymal-epithelial transition (MET) factor tyrosine kinase receptor that blocks the binding of its ligand, hepatocyte growth factor (HGF), which normally activates signaling pathways involved in cell proliferation, motility, and inva... | In the prelicensure clinical trials of tepotinib in patients with solid tumors harboring MET mutations, liver test abnormalities were frequent although usually self-limited and mild. Some degree of ALT elevations arose in 44% of tepotinib treated patients and were above 5 times the upper limit of normal (ULN) in 4%. In... | The cause of serum aminotransferase elevations from tepotinib is unknown, but the pattern of abnormalities suggests direct liver injury. Tepotinib is metabolized in the liver via the cytochrome P450 system, largely CYP 3A4 and 2C8, and is susceptible to drug-drug interactions with agents that inhibit or induce these CY... | The product label for tepotinib recommends monitoring for routine liver tests before starting treatment, at 2 week intervals during the first 3 months of treatment and monthly thereafter as clinically indicated. Serum aminotransferase elevations above 5 times the upper limit of normal should lead to dose reduction or t... | Tepotinib – Tepmetko® | Antineoplastic Agents | null |
Dipyridamole.nxml | Dipyridamole | 2018-01-04 | Dipyridamole is a vasodilator and inhibitor of platelet aggregation that is used to decrease the risk of thromboembolic complications and recurrence of stroke in patients known to have atherosclerotic cerebrovascular disease. Dipyridamole is associated with a low rate of serum enzyme elevations during treatment, but ha... | Dipyridamole (dye' pir id' a mole) is a pyrimidine analogue that is used as an antiplatelet agent to decrease the risk of thromboembolic complications in patients at high risk, such as with a prosthetic heart value, with hypercoagulable states and with a history of arterial thromboses (heart attack, stroke). Dipyridamo... | Dipyridamole has been associated with a low rate of serum enzyme elevations during therapy, but in large clinical trials the frequency of liver enzyme abnormalities was similar with dipyridamole therapy as with placebo. Cases of clinically apparent acute liver injury from dipyridamole have not been published although h... | null | null | Dipyridamole – Generic, Persantine® | Antithrombotic Agents | null |
AmideLocalAnesthetic.nxml | Amide Local Anesthetics | 2017-07-05 | The amide local anesthetics including lidocaine, bupivacaine and ropivacaine are commonly used for pain control during minor surgery or invasive procedures such as biopsies, small excisions or dental work. These local anesthetics have not been linked to serum enzyme elevations, but when given as constant infusions or r... | Lidocaine (lye' do kane), bupivacaine (bue piv' a kane) and ropivacaine (roe piv' a kane) are commonly used local anesthetics that are chemically referred to as aminoethylamides or amide local anesthetics. Their mechanism of anesthetic action is believed to be based upon inhibition of voltage-gated sodium channels, whi... | In clinical trials with the amide local anesthetics, serum aminotransferase and alkaline phosphatase elevations were rarely reported and were generally no more common than with placebo or comparator injections. Despite widespread use for many decades, the local amide anesthetics, when given as single or limited injecti... | The mechanism by which bupivacaine might cause liver injury is unknown, but is most likely due to an idiosyncratic hypersensitivity reaction. The amide local anesthetics are metabolized locally and do not affect the activity of cytochrome P450 enzymes. | null | Bupivacaine – Generic, Marcaine®, Exparel® | Anesthetics, Local | [
{
"cas_registry_number": "137-58-6",
"molecular_formula": "C14-H22-N2-O",
"name": "Lidocaine"
},
{
"cas_registry_number": "23964-58-1",
"molecular_formula": "C13-H20-N2-O3-S",
"name": "Articaine"
},
{
"cas_registry_number": "38396-39-3",
"molecular_formula": "C18-H28-N2-O",
... |
Tovorafenib.nxml | Tovorafenib | 2025-04-08 | Tovorafenib is a small molecule inhibitor of RAF kinase and is used to treat children with relapsed or refractory low-grade glioma harboring a BRAF fusion or rearrangement. Tovorafenib is associated with a high rate of mild-to-moderate elevations in serum aminotransferase and bilirubin levels during therapy but has not... | Tovorafenib (toh voh ra feh’ nib) is a small molecule inhibitor of type II BRAF kinase and is used to treat children with relapsed or refractory low-grade glioma harboring a BRAF fusion or rearrangement. Low grade glioma is the most common cause of brain tumors in children. While they are often referred to as “benign” ... | In the prelicensure trials of tovorafenib, a safety cohort of 172 participants, at least half of whom were treated for more than 1 year, was used to evaluate rates of adverse events. Severe adverse events arose in 45% of patients, most frequently rash (12%), viral infections (7%), fatigue (4%), fever (4%), and hemorrha... | The causes of serum enzyme elevations or liver injury from tovorafenib therapy are possibly due to direct toxicity of the BRAF and MAPK pathway inhibition. Tovorafenib is metabolized in the liver largely via CYP 2C8 and partially by CYP 3A4 and is susceptible to drug-drug interactions with inducers or inhibitors of CYP... | The product label for tovorafenib recommends monitoring of liver tests before therapy, one month after starting and every three months thereafter and as clinically indicated. Serum aminotransferase elevations above 5 times the upper limit of normal or any elevations accompanied by jaundice or symptoms should lead to di... | Tovorafenib – Ojemda® | Antineoplastic Agents | null |
Floxuridine.nxml | Floxuridine | 2018-02-02 | Floxuridine (FUDR) is a pyrimidine analogue used as an antineoplastic agent, usually as a continuous hepatic arterial infusion to treat hepatic metastases from colon cancer. Intraarterial floxuridine is associated with a very high rate of serum enzyme and bilirubin elevations during therapy, and with frequent biliary d... | Floxuridine (flox ure' i deen) is a fluoropyrimidine (fluorodeoxyuridine; FUDR) that has antineoplastic action against several solid tumors including liver, gastrointestinal adenocarcinoma and colorectal cancers. Floxuridine, like fluorouracil, requires conversion to monophosphate and possibly the triphosphate. It appe... | Serum aminotransferase elevations occur in a high proportion of patients given floxuridine by infusion into the hepatic artery, the reported rates ranging from 25% to 100%. These elevations are generally mild to moderate in severity and resolve with stopping therapy. "Chemical hepatitis," however, not infrequently is a... | FUDR can cause both hepatocellular (chemical hepatitis) and cholestatic (biliary strictures, cholangitis) injury. Both appear to be the direct, intrinsic toxicity of FUDR. In a dog animal model, the biliary injury can be reproduced with hepatic artery infusions and the hepatocellular injury (without bile duct damage) b... | The severity of the liver injury linked to floxuridine therapy ranges from minimal and transient serum enzyme elevations to severe cholestatic liver injury due to severe biliary strictures. Hepatic injury arising during FUDR therapy is a frequent reason for dose modification or delay in cycles of therapy. Appearance of... | Floxuridine – Generic | Antineoplastic Agents | null |
Clarithromycin.nxml | Clarithromycin | 2017-08-10 | Clarithromycin is a semisynthetic macrolide antibiotic used for a wide variety of mild-to-moderate bacterial infections. Clarithromycin has been linked to rare instances of acute liver injury that can be severe and even fatal. | Clarithromycin (kla rith" roe mye' sin) is a semisynthetic macrolide antibiotic used widely to treat mild-to-moderate bacterial infections caused by sensitive agents. Clarithromycin, like other macrolide antibiotics such such as eythromycin and azithromycin, is bacteriostatic against many gram positive bacteria includi... | Clarithromycin, like other macrolide antibiotics, has been linked to a low rate of acute, transient and usually asymptomatic elevations in serum aminotransferase levels which occur in 1% to 2% of patients treated for short periods and a somewhat higher proportion of patients given clarithromycin long term. Asymptomatic... | null | The minor serum aminotransferase elevations that appear during therapy with clarithromycin are usually benign, asymptomatic and resolve rapidly whether or not clarithromycin is stopped. The acute hepatic injury with jaundice, however, can be prolonged and troublesome and lead to loss of intrahepatic bile ducts and vani... | Clarithromycin — Generic, Biaxin® | Antiinfective Agents | null |
Pomalidomide.nxml | Pomalidomide | 2022-08-30 | Pomalidomide is an immunomodulatory and antineoplastic agent that is used in the therapy of multiple myeloma. Pomalidomide, like the structurally related agents thalidomide and lenalidomide, is associated with a low rate of serum aminotransferase elevations during therapy and has been implicated in causing rare instanc... | Pomalidomide (pom" a lid' oh mide) is a thalidomide derivative (3-amino-thalidomide) similar to lenalidomide that has potent immunomodulatory and antiangiogenic activity and is used as an antineoplastic agent. The mechanism of action of these agents in the treatment of multiple myeloma is not well defined but may relat... | Serum enzyme elevations occur in 1% to 2% of patients taking pomalidomide and are more frequent with higher doses. The enzyme abnormalities are usually mild and self-limited and rarely require drug discontinuation. In addition pomalidomide has been implicated in rare instances of clinically apparent, acute liver injury... | The mechanism of pomalidomide hepatotoxicity is not clear, but it may be related to its activity in reducing TNF-α production, a potent inflammatory cytokine that activates T cells and promotes inflammation, but is also necessary for normal liver regeneration. Alternatively, the injury may be triggered by an intermedia... | The severity of pomalidomide induced liver injury ranges from transient, asymptomatic elevations in serum enzymes to acute liver injury with jaundice to severe acute liver failure and death. Vanishing bile duct syndrome has been reported with use of thalidomide and lenalidomide but not specifically with pomalidomide. R... | Pomalidomide – Pomalyst® | Antineoplastic Agents | null |
Metaxalone.nxml | Metaxalone | 2021-09-13 | Metaxalone is a centrally acting skeletal muscle relaxant that has been in use for more than 40 years. Metaxalone has not been associated with serum aminotransferase elevations during therapy or with clinically apparent hepatic injury. | Metaxalone (me tax' a lone) acts centrally as a skeletal muscle relaxant, but its efficacy and precise mechanism of action are not well documented. Metaxalone was approved for use in the United States in 1962 and has been a widely used muscle relaxant, but its use recently has declined. Current indications include the ... | According to the product brochure, metaxalone may cause jaundice, although there are no specific case reports of hepatotoxicity from metaxalone in the literature and no prospective trials with routine monitoring of aminotransferase levels. Given its long history, metaxalone appears to be without significant hepatotoxic... | null | null | Metaxalone – Generic, Skelaxin® | Muscle Relaxants | null |
Suvorexant.nxml | Suvorexant | 2025-02-05 | Suvorexant is an orexin receptor antagonist used for the treatment of insomnia and sleep disorders. Suvorexant therapy is associated with rare occurrence of transient serum enzyme elevations but has not been implicated in cases of clinically apparent liver injury. | Suvorexant (soo" voe rex' ant) is an orexin receptor antagonist which is used to treat insomnia. Central nervous system neurons with orexin receptors are involved in wakefulness and are inactive during sleep. Engagement of the orexin receptor results in wakefulness, and loss of the receptor can result in excessive dayt... | In several clinical trials, suvorexant was found to be well tolerated, with serum ALT elevations in 0 to 5% of patients, usually with higher doses, and resolving spontaneously without dose modification. In the registration trials of suvorexant, there were no reports of clinically apparent liver injury. Suvorexant has b... | The mechanism by which suvorexant might cause liver injury is unknown. Suvorexant is metabolized by the cytochrome P450 system (predominantly CYP3A4), and the dose may need to be altered in patients taking strong inhibitors (decreasing dose) or inducers (increasing dose) of the enzymes. The relative lack of serious liv... | null | Suvorexant – Belsomra® | Sedatives and Hypnotics | null |
Aliskiren.nxml | Aliskiren | 2016-02-23 | Aliskiren is a unique antihypertensive agent that acts by direct inhibition of renin and has only recently been introduced into clinical practice. Aliskiren has been linked to rare instances of serum aminotransferase elevations during therapy and rare cases of idiosyncratic, clinically apparent liver injury. | Aliskiren (al' is key' ren) is a direct inhibitor of renin and acts to inhibit its ability to convert angiotensinogen to angiotensin 1, an early step in the renin-angiotensin system pathway. By inhibiting renin and the subsequent production of angiotensin II and aldosterone release, aliskiren results in a decrease in p... | Serum aminotransferase elevations during aliskiren therapy are uncommon and rates of such elevations have not been reported in the large clinical trials that demonstrated its efficacy in hypertension. An instance of serum aminotransferase elevation with jaundice was reported in the registration trials of aliskiren and ... | The mechanism of liver injury due to aliskiren is not known. Aliskiren is metabolized in the liver by the cytochrome P450 (CYP 3A4) system, but has little effect on drug metabolizing activity. Concurrent use of CYP 3A4 inhibitors such as cyclosporin or itraconazole can cause an increase in aliskiren levels. | Severity ranges from asymptomatic elevations in serum aminotransferase levels to mildly symptomatic cholestatic hepatitis with or without jaundice. There are no convincing cases of fulminant hepatic failure, chronic hepatitis or vanishing bile duct syndrome attributable to aliskerin use in the published literature. Pat... | Aliskiren – Tekturna® | Antihypertensive Agents | null |
SERMS.nxml | Selective Estrogen Receptor Modulators | 2017-09-21 | The selective estrogen receptor modulators (SERMs) are a group of nonsteroidal compounds that have estrogen-like effects (agonism) on some tissues (such as bone, skin, heart or vaginal epithelium), but antiestrogen effects (antagonism) on other tissues (such as breast or uterus). Depending on the tissue specificity and... | null | null | null | null | Raloxifene – Generic, Evista® | (Raloxifene) Antineoplastic Agents; Osteoporosis Agents | [
{
"cas_registry_number": "84449-90-1",
"molecular_formula": "C28-H27-N-O4-S",
"name": "Raloxifene"
},
{
"cas_registry_number": "198481-32-2",
"molecular_formula": "C6-H13-N-O5",
"name": "Bazedoxifene"
},
{
"cas_registry_number": "128607-22-7",
"molecular_formula": "Unspecifie... |
Naldemedine.nxml | Naldemedine | 2019-04-15 | Naldemedine is a peripherally acting opioid antagonist which is used to treat constipation caused by chronic opioid use. Naldemedine has not been linked to serum enzyme elevations during therapy or to clinically apparent liver injury. | Naldemedine (nal dem' e deen) is a semisynthetic opiate receptor antagonist which is similar structurally to naltrexone and blocks mu receptors in the enteric nervous system of the gastrointestinal tract resulting in an inhibition of opioid induced slowing of peristalsis. Naldemedine has a large polar side chain that d... | Therapy with naldemedine has not been linked to serum enzyme elevations or to clinically apparent liver injury. In preregistration studies, liver test abnormalities arose in less than 1% of treated patients but were transient, mild and not associated with symptoms. There were no reported cases of liver injury with jaun... | The mechanism by which naldemedine might cause liver injury is not known. Naldemedine is extensively metabolized in the liver, largely by CYP 3A4 and is a substrate for P-glycoprotein. It is susceptible to drug-drug interactions with agents that induce or inhibition CYP 3A or P-glycoprotein activity. Most opioid antago... | null | Naldemedine – Symproic® | Gastrointestinal Agents; Opioid Antagonists | null |
Basiliximab.nxml | Basiliximab | 2017-09-21 | Basiliximab is a chimeric mouse-human monoclonal antibody to CD25, the alpha subunit of the IL-2 receptor, which is found on the surface of T cells. Basiliximab has potent immunosuppressive activity and is used for prevention of organ transplant rejection. Basiliximab has not been linked to serum enzyme elevations duri... | Basiliximab (ba” si lix’ i mab) is a recombinant humanized monoclonal IgG1 kappa antibody to the alpha subunit of the IL2 receptor (CD25). The IL2 receptor is found on T cells and its engagement results in activation of T cells and generation of pro-inflammatory cytokines. Inhibition of the receptor with antibody resul... | Because basiliximab is typically given at the time of renal or liver transplantation, its role in causing serum aminotransferase or alkaline phosphatase elevations is usually difficult to define. In general, side effects including liver test abnormalities have been no more frequent after basiliximab therapy as with pla... | null | null | Basiliximab – Simulect® | Transplant Agents | null |
Esmolol.nxml | Esmolol | 2017-01-15 | Esmolol is a cardioselective beta-blocker used in parenteral forms in the treatment of arrhythmias and severe hypertension. Esmolol has not been linked to instances of clinically apparent drug induced liver injury. | Esmolol (es' moe lol) is considered a “selective” beta-adrenergic receptor blocker in that it has potent activity against beta-1 adrenergic receptors which are found in cardiac muscle, but has little or no activity against beta-2 adrenergic receptors found on bronchial and vascular smooth muscle. Esmolol has a rapid ti... | Esmolol therapy has not been clearly associated with serum aminotransferase elevations or with clinically apparent, acute liver injury. It is often used in critically patients and generally for a short period only. Thus, hepatotoxicity due to esmolol must be very rare, if it occurs at all. Most commonly used beta-block... | The mechanism of drug induced liver injury from beta-blockers such as esmolol is not known. Esmolol undergoes rapid hydrolysis by plasma esterases and is rapidly excreted by the kidneys as inactive metabolites. The rare case of liver injury from beta-blockers is likely to be due to an idiosyncratic reaction. | The severity of liver injury due to beta-blockers ranges from mild serum aminotransferase elevations to acute hepatitis with jaundice. In large case series of drug induced liver injury and acute liver failure due to medications, esmolol has not been listed as a potential cause. There is little information about cross r... | Esmolol – Generic, Brevibloc® | Beta-Adrenergic Receptor Antagonists | null |
Benralizumab.nxml | Benralizumab | 2018-07-05 | Benralizumab is a humanized monoclonal antibody to the interleukin-5 (IL-5) receptor alpha which leads to a decrease in production and maturation of eosinophils and is used therapeutically to reduce allergic symptoms in patients with eosinophilic asthma. Benralizumab has not been associated with serum enzyme elevations... | Benralizumab (ben" ra liz' ue mab) is a recombinant, humanized IgG1 monoclonal antibody to the IL-5 receptor alpha which blocks the cytokine from inducing maturation and proliferation of eosinophils [3,12]. IL-5 is a cytokine growth and stimulating factor which has a selective role in recruiting eosinophils from the bo... | In large clinical trials, rates of serum aminotransferase and alkaline phosphatase elevations were similar in patients receiving benralizumab as in those on placebo [6-11]. Indeed, rates of most adverse reactions were similar in patients who received placebo injections or standard care. In prelicensure trials in more t... | null | null | Benralizumab – Fasenra® | Antiasthmatic Agents | null |
Asciminib.nxml | Asciminib | 2023-10-08 | Asciminib is a tyrosine kinase inhibitor that specifically targets myristoyl pocket of ABL1 and is used to treat refractory forms of Philadelphia chromosome positive chronic myelocytic leukemia. Serum aminotransferase elevations occur in a proportion of patients treated with asciminib, but episodes of clinically appare... | Asciminib (as kim’ in ib) is an orally available, tyrosine kinase inhibitor that targets the myristoyl pocket of ABL1 resulting in inhibition of the abnormal fusion kinase BCR-ABL1 that drives cellular proliferation in chronic myelocytic leukemia (CML) associated with the Philadelphia chromosome (Ph+). The Philadelphia... | In the prelicensure clinical trials of asciminib in patients with refractory and extensively treated CML, ALT elevations arose in 13% of patients but were usually self-limited and mild. ALT elevations above 5 times the upper limit of normal (ULN) were uncommon, being found in 3% of treated patients. The ALT elevations ... | The cause of serum aminotransferase elevations from asciminib is unknown, but the pattern of abnormalities suggests a mild degree of direct hepatotoxicity. Asciminib is metabolized in the liver via the cytochrome P450 system, largely CYP 3A4 and 2C9 and is susceptible to drug-drug interactions with agents that inhibit ... | The product label for asciminib does not recommend routine monitoring of liver laboratory tests during therapy. Serum aminotransferase elevations above 5 times ULN (if detected) should lead to dose reduction or temporary cessation of treatment with careful monitoring if restarted after resolution of the abnormalities. ... | Asciminib – Scemblix® | Antineoplastic Agents | null |
Anticonvulsants.nxml | Anticonvulsants | 2019-04-18 | null | null | null | null | null | null | null | null |
Cabotegravir.nxml | Cabotegravir | 2023-06-17 | Cabotegravir is an antiviral agent that inhibits the human immunodeficiency virus (HIV) integrase and is used in combination with rilpivirine, a non-nucleoside HIV reverse transcription inhibitor, in the treatment of HIV infection and the acquired immunodeficiency syndrome (AIDS). The fixed combination of cabotegravir ... | Cabotegravir (ka” boe teg’ ra vir) is an antiretroviral drug that targets the HIV integrase, one of the three critical viral enzymes involved in HIV replication. Cabotegravir binds to the catalytic site of the HIV integrase, preventing the strand transfer activity and integration of the provirus into the host genome. C... | In large clinical trials, switching antiretroviral therapy of HIV infection to the combination of parenteral injections of long acting cabotegravir and rilpivirine was associated with alanine aminotransferase (ALT) elevations in up to 7% of patients, but levels above 5 times the upper limit of normal (ULN) arose in onl... | Cabotegravir is metabolized by the liver and undergoes glucuronidation as a part of its metabolic clearance. It does not have an effect on the CYP 450 system. Concomitant use of potent inducers of UGT1A can result in lower plasma levels which can predispose to virologic failure and development of antiviral resistance. | Serum enzyme elevations during combination therapy with cabotegravir and rilpivirine are not uncommon but are generally transient, mild-to-moderate in severity, and often attributable to other causes. Nevertheless, aminotransferase elevations above 5 times the ULN, if confirmed, warrant dose interruption and evaluation... | Cabotegravir – Cabenuva®, Apretude®, Vocabria® | Antiviral Agents | [
{
"cas_registry_number": "1051375-10-0",
"molecular_formula": "C19-H17-F2-N3-O5",
"name": "Cabotegravir"
},
{
"cas_registry_number": "500287-72-9",
"molecular_formula": "C22-H18-N6",
"name": "Rilpivirine"
}
] |
Vericiguat.nxml | Vericiguat | 2023-06-16 | Vericiguat is an orally available stimulator of soluble guanylate cyclase (sGC), a critical enzyme in the action of nitric oxide in inducing vascular relaxation, which is used in patients with chronic heart failure to reduce the risk of death and hospitalization. Vericiguat is associated with a low rate of serum aminot... | Vericiguat (ver" i sig' ue at) is an orally available, small molecule stimulator of soluble guanylate cyclase which is used in patients with chronic heart failure to reduce the risk of death and hospitalizations for heart failure. Soluble guanylate cyclase (sGC) is responsible for the relaxation of smooth muscle cells ... | In preregistration trials, serum aminotransferase elevations with mild bilirubin elevations were reported to occur in 2% of patients on vericiguat, but similar rates were reported with placebo therapy and the abnormalities resolved without dose modification or discontinuation of therapy. These abnormalities were consid... | The mechanism by which vericiguat might cause serum ALT elevations or liver injury is not known. Hepatic metabolism of vericiguat is via glucuronidation by UGT1A9 with minor involvement of the cytochrome P450 system. Vericiguat has not been associated with clinically significant drug-drug interactions. | The serum aminotransferase elevations that occur on vericiguat therapy are usually self-limited and rarely require dose modification or discontinuation. No instances of clinically apparent acute hepatitis, acute liver failure, chronic hepatitis or vanishing bile duct syndrome have been attributed to vericiguat. Cross s... | Vericiguat – Verquvo® | Cardiovascular Agents | null |
Mercaptopurine.nxml | Mercaptopurine | 2017-08-17 | Mercaptopurine (also referred to as 6-mercaptopurine or 6-MP) is a purine analogue that is effective both as an anticancer and an immunosuppressive agent, and is used to treat leukemia and autoimmune diseases as a corticosteroid-sparing agent. Mercaptopurine therapy is associated with a high rate of serum aminotransfer... | Mercaptopurine (mer kap" toe pure' een) is a purine analogue that acts as an antimetabolite by antagonism of purine metabolism which results in a general inhibition of DNA, RNA and subsequent protein synthesis. Mercaptopurine also has antiinflammatory and immunosuppressive activity, inhibiting the maturation of T cells... | Mercaptopurine has been associated with several forms of hepatotoxicity. Patients receiving mercaptopurine for leukemia often have transient and asymptomatic rises in serum aminotransferase or alkaline phosphatase levels and a proportion of these patients develop jaundice, particularly when it is given in high doses. I... | Mercaptopurine is believed to have a direct, dose related hepatotoxic effect and similar types of injury can be reproduced in animal models. The toxic effects of mercaptopurine, and particularly the myelotoxicity, have been linked to higher levels of methyl-mercaptopurine, a product of one of the metabolic pathways of ... | The acute liver injury caused by mercaptopurine usually begins to improve rapidly upon stopping the medication, but instances of progression to hepatic failure despite discontinuation of mercaptopurine have been reported. There are no known specific treatments for mercaptopurine hepatotoxicity. Rechallenge with mercapt... | Mercaptopurine – Generic, Purinethol® | Antineoplastic Agents | null |
Yohimbine.nxml | Yohimbine | 2020-04-05 | Yohimbine is an indole alkaloid derived from the bark of the Central African yohimbe tree (Pausinystalia yohimbe) that is widely used as therapy for erectile dysfunction. Yohimbine use has been associated with occasional severe adverse events, but has not been linked to serum enzyme elevations or clinically apparent ac... | Yohimbine (yoe him' been) is a popular and widely used herbal which was traditionally used in Africa for multiple conditions including cough, fever, leprosy, heart disease and as an anesthetic, hallucinogen and aphrodisiac. In the West, yohimbe became popular as a sexual stimulant and used to treat erectile dysfunction... | In small clinical trials and case series, yohimbine therapy has not been linked to serum enzyme elevations or clinical liver disease. Although yohimbine is often found in weight loss and muscle building herbal combinations, it has not been associated with cases of clinically apparent acute liver injury.\n\nLikelihood s... | null | null | Yohimbine – Generic | Herbal and Dietary Supplements | null |
Phenotypes_cirrhosis.nxml | Cirrhosis | 2019-11-20 | null | null | null | null | null | null | null | null |
Diphenoxylate.nxml | Diphenoxylate | 2019-04-25 | Diphenoxylate is synthetic opioid that primarily affects opiate receptors in the intestine and is used to treat diarrhea. Diphenoxylate has not been linked to serum enzyme elevations during therapy or to clinically apparent liver injury. | Diphenoxylate (dye” fen ox’ i late) is a synthetic piperidine derivative that acts as a mild opiate receptor agonist (predominant µ type receptors), but is used largely for the treatment of diarrhea rather than pain. Diphenoxylate is similar to loperamide and is not structurally related to morphine or codeine, and has ... | As with most opiates in current use, therapy with diphenoxylate with atropine has not been linked to serum enzyme elevations. There have been no convincing cases of idiosyncratic acute, clinically apparent liver injury attributed to diphenoxylate. The reason for its lack of hepatotoxicity may relate partially to the lo... | null | null | Diphenoxylate (with Atropine) – Generic, Lomotil® | Gastrointestinal Agents; Opioids | null |
causalityassess.nxml | Causality Assessment Tools | 2019-05-04 | null | null | null | null | null | null | null | null |
VitaminD.nxml | Vitamin D | 2021-05-27 | Vitamin D is a fat soluble vitamin important in the regulation of calcium metabolism and bone health and deficiency of which cause rickets, a disease marked by lack of mineralization of bone. Conventional doses of vitamin D are well tolerated without appreciable adverse effects. High doses of vitamin D can be toxic, le... | Vitamin D is typically referred to as a fat soluble vitamin, but actually represents two related fat soluble substances cholecalciferol (koe" le kal sif' er ol: vitamin D3) and ergocalciferol (er" goe kal sif’ er ol: vitamin D2), both of which can be used to cure or prevent rickets. These molecules are made from 7-dehy... | Neither normal nor excessively high intakes of vitamin D are associated with liver injury or liver test abnormalities. Hypervitaminosis D and vitamin D intoxication generally arise with intakes above 50,000 IU daily, but lower doses may induce toxicity in susceptible individuals such as patients with renal osteodystrop... | Vitamin D in high doses increases absorption of dietary calcium, but also mobilizes calcium from bone. The symptoms of vitamin D intoxication are largely those of hypercalcemia. While hepatocytes, cholangiocytes, stellate cells and resident immune cells in the liver have vitamin D receptors, there is no evidence that v... | null | Vitamin D – Generic, Rocaltrol® (Calcitriol, Vitamin D3) | Vitamins | [
{
"cas_registry_number": "67-97-0",
"molecular_formula": "C27-H44-O",
"name": "Cholecalciferol"
},
{
"cas_registry_number": "50-14-6",
"molecular_formula": "C28-H44-O",
"name": "Ergocalciferol"
}
] |
Tivozanib.nxml | Tivozanib | 2023-12-26 | Tivozanib is a small molecule multi-kinase inhibitor that is used in the treatment of relapsed or refractory renal cell carcinoma. Tivozanib is associated with transient and usually mild elevations in serum aminotransferase during therapy and but has not been linked instances of clinically apparent acute liver injury. | Tivozanib (tye voe’ za nib) is an orally available, small molecule multi-kinase inhibitor which is used as a third line treatment of relapsed or refractory renal cell carcinoma. Tivozanib inhibits multiple tyrosine kinases, including vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, VEGFR-3, c-kit, and pl... | In the published preregistration clinical trials of tivozanib, rates of serum ALT or AST elevations ranged from 10% to 29%, with 1% to 4% of treated patients having elevations above 5 times the upper limit of normal (ULN). Instances of clinically apparent liver injury including deaths with hepatic failure were reported... | Tivozanib therapy has been clearly linked to serum enzyme elevations the cause of which is unknown, but similar rates and patterns of liver test abnormalities have been reported with many kinase inhibitors and particularly with multi-kinase inhibitors such as tivozanib. Tivozanib is metabolized in the liver largely by ... | Tivozanib has been clearly linked to serum aminotransferase elevations but has not been clearly linked to clinically apparent liver injury. The product label for tivozanib does not recommend routine monitoring of liver tests. But if found, serum aminotransferase elevations above 5 times ULN should lead to dose reductio... | Tivozanib – Fotivda® | Antineoplastic Agents | null |
Trimethobenzamide.nxml | Trimethobenzamide | 2020-09-03 | Trimethobenzamide is an orally available, antiemetic agent used in the therapy of nausea and vomiting associated with medications and gastrointestinal, viral and other illnesses. Trimethobenzamide has not been linked convincingly to elevations in serum enzymes during therapy and despite widescale use for almost 50 year... | Trimethobenzamide (trye meth” oh ben’ za mide) is a benzamide used to prevent nausea and vomiting. Its mechanism of action is uncertain, but it is believed to act directly on the central chemoreceptor nausea trigger zone of the medulla oblongata of the brain. It has weak antihistaminic activity, but does not appear to ... | Serum aminotransferase elevations during trimethobenzamide therapy are uncommon and rates of such elevations have not been reported in large clinical trials. A single case report of hepatitis and jaundice attributed to trimethobenzamide was published in 1967 that predated availability of tests for hepatitis A, B and C ... | Trimethobenzamide is metabolized in the liver but appears to have few drug-drug interactions. The mechanism by which it might cause liver injury is unknown. | The hepatic injury caused by trimethobenzamide is usually mild and reversible with stopping the medication. Trimethobenzamide has not been linked to cases of acute liver failure, chronic hepatitis or vanishing bile duct syndrome. There is no information about possible cross sensitivity to liver injury with other antiem... | Trimethobenzamide – Generic, Tigan® | Gastrointestinal Agents | null |
editorsandreviewers.nxml | LiverTox – Editors and External Expert Review Committee | 2025-04-02 | null | null | null | null | null | null | null | null |
Imipramine.nxml | Imipramine | 2018-04-25 | Imipramine is a tricyclic antidepressant that continues to be widely used in the therapy of depression. Imipramine can cause mild and transient serum enzyme elevations and is rare cause of clinically apparent acute cholestatic liver injury. | Imipramine (im ip' ra meen) is a dibenzazepine derived tricyclic antidepressant which acts by inhibition of serotonin and norepinephrine reuptake within synaptic clefts in the central nervous system, thus increasing brain levels of these neurotransmitters. Imipramine is indicated for therapy of depression and was appro... | Liver test abnormalities have been reported to occur in up to 20% of patients on long term therapy with imipramine, but elevations are uncommonly above 3 times the upper limit of normal. The aminotransferase abnormalities are usually mild, asymptomatic and transient, reversing even with continuation of medication. Rare... | The mechanism by which imipramine causes serum aminotransferase elevation is not known. It undergoes extensive hepatic metabolism and a possible cause of liver injury is production of an intermediate of metabolism that triggers a hypersensitivity reaction. | The serum aminotransferase elevations that occur on imipramine therapy are usually self-limited and do not require dose modification or discontinuation of therapy. The acute hepatitis caused by imipramine is typically self-limited and benign, but can be severe and even fatal. Instances of prolonged jaundice compatible ... | Imipramine – Tofranil® | Antidepressant Agents | null |
Bilberry.nxml | Bilberry | 2019-02-20 | Bilberry is a popular herb used alone or as a component of multiingredient herbal products that has several purported uses including improving stamina, weight control, mental concentration and vision as well as various gastrointestinal, kidney, rheumatologic and vascular conditions. Neither fresh bilberries nor fruit o... | Bilberry is a popular herbal product derived from the berries and leaves of the bilberry plant (Vaccinium myrtillus), a deciduous, perennial shrub native to Europe and North America which produces dark purple berries resembling blueberries. Typically, bilberry is prepared from the berries or leaves and contains anthocy... | Despite widespread use, bilberry has not been specifically linked to liver injury, either in the form of transient serum enzyme elevations or clinically apparent acute liver injury. Bilberry demonstrates minimal effect on drug metabolism but may affect platelet aggregation and predispose to excessive bleeding in patien... | null | null | Bilberry – Generic | Herbal and Dietary Supplements | null |
Perindopril.nxml | Perindopril | 2018-02-11 | Perindopril is an angiotensin-converting enzyme (ACE) inhibitor used in the therapy of hypertension and stable coronary artery disease. Perindopril is associated with a low rate of transient serum aminotransferase elevations and has been linked to rare instances of acute liver injury. | Perindopril (per in' doe pril) is an ACE inhibitor which is approved for use alone and in combination with other agents in the therapy of hypertension. Like other ACE inhibitors, perindopril inhibits the conversion of angiotensin I, a relatively inactive molecule, to angiotensin II which is the major mediator of vasoco... | Perindopril, like other ACE inhibitors, has been associated with a low rate of serum aminotransferase elevations (<2%) that, in controlled trials, was similar to the rate with placebo therapy. These elevations were transient and rarely required dose modification. Instances of jaundice and hepatic injury are listed as p... | The cause of the minor serum aminotransferase elevations associated ACE inhibitors including perindopril is not known. Perindopril is hydrolyzed in the liver to the active metabolite perindoprilat, but undergoes minimal further hepatic metabolism. Idiosyncratic liver injury due to the ACE inhibitors is likely due to a ... | There have been too few instances of perindopril associated liver injury described to provide an overall description of its course and outcome. Most instances of acute liver injury reported with ACE inhibitors have been self limited, but there have been rare reports of acute liver failure due to captopril, enalapril, l... | Perindopril – Generic, Aceon® | Angiotensin-Converting Enzyme Inhibitors | null |
Butterbur.nxml | Butterbur | 2019-02-18 | Butterbur is a popular herbal preparation that is used to treat migraine headaches, allergic rhinitis and respiratory illnesses. Butterbur is an extract of the roots of the butterbur bush and the extract has to be processed carefully to eliminate harmful pyrrolizidine alkaloids that occur naturally in the plant. Butter... | Butterbur is a popular herbal product derived from the rhizomes and stems of the perennial butterbur bush (Petasites hybridus), a plant native to Europe. Butterbur is so named because its large leaves were used to wrap butter for storage. Butterbur extracts have been used for centuries in traditional medicine and purpo... | Despite widespread use, butterbur extracts that are free of pyrrolizidine alkaloids have not been specifically linked to liver injury, either in the form of transient serum enzyme elevations or clinically apparent acute liver injury. However, because the processing of butterbur is critical to the safety of the herbal p... | The mechanism by which some preparations of butterbur might cause liver injury is not known but is likely due to a contaminant or mislabeling of the product. Butterbur-drug interactions have not been defined. While pyrrolizidine alkaloids are mentioned as the possible cause of liver injury associated with butterbur use... | Patients on butterbur who develop unexplained symptoms such as fatigue, nausea, abdominal pain or dark urine should have routine liver tests drawn and discontinue the use of the herb if there are any abnormalities.\n\nOther Names: Petasites Extract, Purple Butterbur\n\nDrug Class: Herbal and Dietary Supplements | Butterbur – Generic | Herbal and Dietary Supplements | null |
Gemfibrozil.nxml | Gemfibrozil | 2017-01-24 | Gemfibrozil is a fibric acid derivative used in the therapy of hypertriglyceridemia and dyslipidemia. Gemfibrozil therapy is associated with mild and transient serum aminotransferase elevations and with rare instances of acute liver injury. | Gemfibrozil (jem fye' broe zil) is a fibric acid derivative and lipid lowering agent. The lipid lowering activity of gemfibrozil is probably mediated by its interactions with the peroxisome proliferator activated receptor alpha (PPARα), which regulates gene expression of enzymes involved in fatty acid oxidation. Gemfib... | Mild, transient serum aminotransferase elevations develop in approximately 20% of patients receiving gemfibrozil, but values above 3 times normal in 5% or less. These abnormalities are usually asymptomatic and transient, resolving even with continuation. However, there have also been rare reports of clinically apparent... | The mechanism of hepatotoxicity of the gemfibrozil is not known, but is likely due to an immunologic response to an intermediate of its metabolism. | The few published instances of clinically apparent hepatotoxicity due to gemfibrozil have been mild and self-limited. There have been no published reports of acute liver failure, chronic hepatitis or vanishing bile duct syndrome related to gemfibrozil. It is unclear whether liver injury is a class effect of the fibrate... | Gemfibrozil – Generic, Lopid® | Antilipemic Agents | null |
Melatonin.nxml | Melatonin | 2020-01-10 | Melatonin is a hormone produced by the pineal gland that has multiple effects including somnolence, and is believed to play a role in regulation of the sleep-wake cycle. Melatonin is available over-the-counter and is reported to have beneficial effects on wellbeing and sleep. Melatonin has not been implicated in causin... | Melatonin is a small molecular weight amine (N-actyl-5-methoxytryptamine) synthesized in the pineal gland from serotonin (5-HT). Melatonin is released into the circulation in a circadian pattern, the plasma levels being low during the day and high at night. In persons with normal sleep-wake patterns, peak melatonin val... | In several clinical trials, melatonin was found to be well tolerated and not associated with serum enzyme elevations or evidence of liver injury. Despite wide scale use, melatonin has not been convincingly linked to instances of clinically apparent liver injury.\n\nLikelihood score: E (unlikely cause of clinically appa... | null | null | Melatonin – Generic, In Combination | Herbals and Dietary Supplements | null |
DiazepamOral.nxml | Diazepam (Oral) | 2023-06-22 | Diazepam is a benzodiazepine that is widely used orally as an anxiolytic agent and muscle relaxant. Intravenous forms of diazepam are used for acute severe agitation, as a premediation for anesthesia, a sedative for minor surgery or invasive procedures, and for treatment of status epilepticus or severe recurrent seizur... | Diazepam (dye az' e pam) is a benzodiazepine that in oral formulations is used for the therapy of anxiety, alcohol withdrawal symptoms and muscle spasms. Parenteral forms of diazepam are used for control of seizures and status epilepticus and as an adjunct to anesthesia or sedation for minor surgical procedures. The se... | Like other benzodiazepines, diazepam is rarely associated with serum ALT or alkaline phosphatase elevations during therapy. Furthermore, clinically apparent liver injury from diazepam is exceedingly rare. A small number of cases of hepatic injury have been described in patients on oral diazepam, but the clinical patter... | The liver injury from benzodiazepines is probably due to a rarely produced intermediate metabolite. Diazepam is metabolized in the liver to its active metabolite which is excreted in the urine. | The case reports of hepatic injury due to oral diazepam were followed by complete recovery, without evidence of residual or chronic injury. No cases of acute liver failure or chronic liver injury due to diazepam have been described. There is no information about cross reactivity with other benzodiazepines (clobazam, cl... | Diazepam – Generic, Valium® (Trade name discontinued) | Benzodiazepines, Antianxiety Agents | null |
Mexiletine.nxml | Mexiletine | 2020-02-06 | Mexiletine is an oral antiarrhythmic agent that is used for suppression of ventricular arrhythmias. Long term mexiletine therapy is associated with a low rate of serum enzyme elevations and is a rare cause of clinically apparent acute liver injury. | Mexiletine (mex il' e teen) is an analogue of the local anesthetic lidocaine and has electrophysiological effects that resemble quinidine (antiarrhythmic Class IB). Mexiletine appears to act by blocking open sodium channels and outward potassium channels. As a consequence, it decreases cardiac automaticity, increases r... | In clinical trials, mexiletine was associated with a low rate of serum aminotransferase and alkaline phosphatase elevations (~0.5%). Despite wide scale use, mexiletine has only rarely been linked to cases of clinically apparent liver injury. Most cases are associated with a hypersensitivity reaction. Typically, patient... | The liver injury from mexiletine appears to be mediated by a hypersensitivity reaction. Mexiletine is metabolized in the liver by the cytochrome P450 system and an immunoallergic metabolite may be produced. The hypersensitivity reaction to mexiletine may be more common in Asian than other populations. | The liver injury due to mexiletine is usually overshadowed by the signs and symptoms of hypersensitivity. No cases of acute liver failure, chronic hepatitis or vanishing bile duct syndrome due to mexiletine have been reported. The signs and symptoms of hypersensitivity typically respond rapidly to corticosteroid therap... | Mexiletine – Generic, Mexitil® | Antiarrhythmic Agents | null |
Pegcetacoplan.nxml | Pegcetacoplan | 2024-07-20 | Pegcetacoplan is a small peptide inhibitor of complement that is used to treat adults with paroxysmal nocturnal hemoglobinuria. Serum aminotransferase elevations occur in a proportion of patients treated pegcetacoplan, but episodes of clinically apparent liver injury with jaundice have not been reported with its use. | Pegcetacoplan (peg set’ a koe’ plan) is a subcutaneously administered small peptide inhibitor of complement C3 and its activation fragment C3b that blocks the cleavage of C3 and the downsteam effectors of completement activation. Pegcetacoplan is used in conditions marked by excessive activation of complement including... | In the prelicensure clinical trials of pegcetacoplan in patients with PNH, ALT elevations were rarely described, and there were no reports of hepatic adverse events or discontinuations because of abnormal liver tests. Serum ALT and AST elevations are not uncommon in patients with untreated PNH, usually due to hemolysis... | The cause of serum aminotransferase elevations from pegcetacoplan is unknown but suspected to be due to the underlying hemolysis or thromboses and unrelated to therapy. Pegcetacoplan is comprised of two identical 15-aminoacid peptides covalently joined by a molecule of polyethylene glycol (PEG). It is metabolized by ce... | The product label for pegcetacoplan does not recommend routine monitoring of liver laboratory tests during therapy. Serum aminotransferase elevations above 5 times the upper limit of normal (if detected) should lead to dose reduction or temporary cessation of treatment with careful monitoring if restarted after resolut... | Pegcetacoplan – Empaveli® | Hematologic Agents | null |
Phenotypes_sinus.nxml | Sinusoidal Obstruction Syndrome (Veno-occlusive Disease) | 2019-05-04 | null | null | null | null | null | null | null | null |
Iloperidone.nxml | Iloperidone | 2023-06-05 | Iloperidone is a second generation (atypical) antipsychotic agent that is used for treatment of schizophrenia. Iloperidone is associated with a low rate of serum aminotransferase elevations during therapy and has not been linked to instances of clinically apparent acute liver injury. | Iloperidone (eye" loe per' i done) is a second-generation antipsychotic agent which appears to act as a dopamine type 2 (D2) and serotonin (5-HT)-2A receptor antagonist whose structure and mechanism of action are similar to risperidone. Several randomized controlled trials have shown that iloperidone improves symptoms ... | Liver test abnormalities occur in 1% to 3% of patients on long term therapy with iloperidone, but similar rates are reported with placebo therapy and with comparator agents. The ALT elevations are usually mild, transient and usually resolve even without dose modification or drug discontinuation. There have been no publ... | The mechanism by which iloperidone might cause serum ALT elevations or liver injury is not known. Iloperidone is extensively metabolized by the cytochrome P450 system (CYP 2D6 and 3A4) to its active metabolite and is susceptible to drug-drug interactions with agents that inhibit or induce these microsomal enzymes. | The serum aminotransferase elevations that occur on iloperidone therapy are usually self-limited and usually do not require dose modification or discontinuation. No instances of acute liver failure, chronic hepatitis or vanishing bile duct syndrome have been attributed to iloperidone. Cross sensitivity to liver related... | Iloperidone – Generic, Fanapt® | Antipsychotic Agents | [
{
"cas_registry_number": "133454-47-4",
"molecular_formula": "C24-H27-F-N2-O4",
"name": "Iloperidone"
},
{
"cas_registry_number": "106266-06-2",
"molecular_formula": "C23-H27-F-N4-O2",
"name": "Risperidone"
}
] |
Pitolisant.nxml | Pitolisant | 2021-08-18 | Pitolisant is a histamine type 3 receptor (H3) antagonist and inverse agonist that is used in the therapy of excessive daytime sleepiness and cataplexy in patients with narcolepsy. Pitolisant has not been associated with serum enzyme elevations during therapy or to instances of idiosyncratic acute liver injury. | Pitolisant (pi tol’ i sant) is an orally available, small molecule histamine 3 (H3) receptor antagonist and inverse agonist that is used to treat excessive daytime sleepiness in adults with narcolepsy and for cataplexy associated with narcolepsy. Narcolepsy is associated with a deficiency of hypothalamic cells producin... | In placebo-controlled trials of pitolisant in patients with narcolepsy, minor serum aminotransferase elevations occurred in a small proportion of patients during therapy, but rates of enzyme elevations were similar to those in placebo recipients. In preregistration trials, there were no instances of clinically apparent... | The mechanism by which pitolisant might cause liver injury is not known but may be due to a toxic or immunogenic intermediate product of its metabolism. Pitolisant is metabolized in the liver largely by CYP 2D6 and 3A4 and is susceptible to drug-drug interactions with inhibitors or inducers of these enzymes.\n\nDrug Cl... | null | Pitolisant – Wakix® | CNS Drugs | null |
Guanfacine.nxml | Guanfacine | 2021-08-25 | Guanfacine is a selective alpha-adrenergic receptor agonist used for the treatment of hypertension and attention deficit hyperactivity disorder (ADHD) in adults and children. Guanfacine has not been linked to serum enzyme elevations during treatment or to cases of acute, clinically apparent liver injury. | Guanfacine (gwahn' fa seen) is a selective alpha-2A-adrenergic receptor agonist initially approved as therapy of hypertension and subsequently for management of attention deficit hyperactivity disorder (ADHD). It is currently used mostly as therapy of ADHD, both in children and adults. Therapy with extended release for... | In the multiple clinical trials of guanfacine in adolescents and children with ADHD there were no reports of serum enzyme elevations or in instances of clinically apparent liver injury. Furthermore, despite widescale use of the agent for both hypertension and ADHD, there have been no reports of clinically apparent live... | The mechanism by which guanfacine might cause liver injury is unknown. Guanfacine is metabolized in the liver by the cytochrome P450 system, predominantly CYP 3A4 and production of a toxic intermediate or immunogenic byproduct are reasonable explanations. Guanfacine is susceptible to drug-drug interactions with agents ... | null | Guanfacine – Generic, Tenex®, Intuniv® | Antihypertensive Agents | null |
Revefenacin.nxml | Revefenacin | 2019-04-12 | Revefenacin is a synthetic anticholinergic agent that is used as a once daily, nebulized inhalant for maintenance treatment of patients with chronic obstructive pulmonary disease. Revefenacin has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury. | Revefenacin (rev" e fen' a sin) is a synthetic anticholinergic which inhibits the muscarinic actions of acetylcholine on autonomic nerve endings, which decreases bronchial smooth muscle contractions and can alleviate bronchospasm in patients with chronic obstructive pulmonary disease (COPD). Revefenacin has potent acti... | Like other anticholinergic agents, revefenacin has not been linked to episodes of liver enzyme elevations or clinically apparent liver injury. Another reason for its hepatic safety may relate to its low systemic absorption when administered by inhaler.\n\nLikelihood score: E (unlikely cause of clinically apparent liver... | null | null | Revefenacin – Yupelri® | Anticholinergic Agents | null |
MultipleSclerosisAge.nxml | Multiple Sclerosis Agents | 2022-09-07 | null | null | null | null | null | null | null | null |
Etravirine.nxml | Etravirine | 2018-02-20 | Etravirine is a nonnucleoside reverse transcriptase inhibitor used in combination with other agents in the therapy of human immunodeficiency virus (HIV) infection and the acquired immunodeficiency syndrome (AIDS). Etravirine has been associated with transient serum aminotransferase elevations and with hypersensitivity ... | Etravirine (e" tra vir' een) is a “second generation” nonnucleoside reverse transcriptase inhibitor that acts by noncompetitive binding to the HIV reverse transcriptase and indirectly inactivating its catalytic site. Etravirine is similar to nevirapine and efavirenz in its mechanism of action, but shares minimal struct... | Serum aminotransferase elevations occur in a high proportion of patients on etravirine therapy, but increases above 5 times the upper limit of normal occur in only 2% to 3% of patients; this rate may be higher in patients who have hepatitis C coinfection. In most studies, the rate of liver enzyme elevations was no diff... | Etravirine is extensively metabolized in the liver via the P450 system (CYP 2C19, 3A4, and 2C9) and hepatotoxicity from etravirine is likely due to a hypersensitivity reaction to an immunogenic intermediate of its metabolism. | The severity of the liver injury reported with etravirine has ranged from mild and transient enzyme elevations to clinically apparent liver injury and acute liver failure. Chronic hepatitis and vanishing bile duct syndrome have not been reported. If hypersensitivity hepatic injury does occur, rechallenge should be avoi... | Etravirine – Intelence® | Antiviral Agents | null |
Ziprasidone.nxml | Ziprasidone | 2023-06-10 | Ziprasidone is an atypical antipsychotic used in the treatment of adults with schizophrenia and bipolar disorder. Use of ziprasidone has not been consistently associated with serum enzyme elevations but has been linked to rare instances of hypersensitivity reactions accompanied by mild-to-moderate acute liver injury. | Ziprasidone (zi pras' i done) is a benzisothiazolyl piperazine-type atypical antipsychotic that appears to act as both a dopamine type 2 (D2) and a serotonin (5-HT2) receptor antagonist. It also has moderate activity against α-adrenergic and histamine receptors. Ziprasidone is indicated for the therapy of schizophrenia... | Liver test abnormalities have been reported in patients taking ziprasidone, but they have not been well characterized in the literature and the frequency of elevations appears to be similar to placebo therapy. Several instances of hypersensitivity reactions have been reported in patients taking ziprasidone, arising wit... | Ziprasidone is largely excreted unchanged in the urine and its hepatic metabolism is minimal, perhaps accounting for why hepatotoxicity is rare. The liver injury caused by ziprasidone is likely due to hypersensitivity and is idiosyncratic in nature. Ziprasidone is less likely to cause weight gain than other atypical an... | The hypersensitivity reactions to ziprasidone are likely to recur with reexposure and rechallenge should be avoided. Ziprasidone has not been reported to cause acute liver failure, chronic hepatitis or vanishing bile duct syndrome in the published literature. Persons with hypersensitivity to ziprasidone are likely to t... | Ziprasidone – Generic, Geodon® | Antipsychotic Agents | null |
HorseChestnut.nxml | Horse Chestnut | 2018-03-30 | Horse chestnut is an herb prepared from the leaves or seeds of the Horse chestnut tree (Aesculus hippocastanum), and is used primarily for complications of venous insufficiency including varicose veins, ankle swelling, and leg cramps. Horse chestnut has been implicated in rare instances of clinically apparent liver inj... | The horse chestnut tree is native to Persia and Eastern Asia, but has been introduced worldwide and is widely planted for its handsome shape and attractive leaves, nuts and flowers. The horse chestnut should not be confused with the California or Ohio chestnuts (Aesculus california and glabra), which are different spec... | Despite wide scale use, there have been few published instances of liver injury due to horse chestnut. In isolated cases of liver toxicity attributed to horse chestnut extracts, injury became apparent between 4 and 8 weeks after starting the herbal and were associated with either hepatocellular or mixed patterns of ser... | The cause of liver injury attributed to horse chestnut extracts is unknown, but is likely to be idiosyncratic. | Liver injury attributed to horse chestnut use has been relatively mild and self-limited. There have been no instances of acute liver failure, death, chronic hepatitis, cirrhosis or vanishing bile duct syndrome attributed to its use.\n\nOther Names: Aescin, escine, venastat\n\nDrug Class: Herbal and Dietary Supplements | Horse Chestnut – Generic | Herbal and Dietary Supplements | null |
Centella.nxml | Centella asiatica | 2024-04-24 | Centella asiatica, commonly known as gotu kola or Asian pennywort, is a herbaceous, flowering, perennial plant native to tropical areas of Southeast Asia and Australia and used as a food as well as in traditional medicine. While generally regarded as safe, Centella has been linked to rare instances of clinically appare... | Centella also known as gotu kola, tiger grass or Indian pennywort is made from fresh or dried leaves of Centella asiatica a creeping herbaceous, flowering plant native to tropical swampy areas of Southeast Asia and Australia but now found in many tropical and subtropical areas of the world. It is eaten as a vegetable a... | Centella extracts have not been linked to serum enzyme elevations during therapy, although there have been few prospective studies in humans that have reported on laboratory test results during treatment. Nevertheless, rare instances of acute and symptomatic liver injury have been published, including a case series in ... | null | Gotu kola hepatotoxicity is generally self-limited and only mild-to-moderate in severity. Appearance of clinically evident liver injury developing during therapy should lead to prompt withdrawal of the herbal product. Rechallenge should be avoided. | Centella asiatica – Generic | Herbal and Dietary Supplements | null |
Cobimetinib.nxml | Cobimetinib | 2017-06-01 | Cobimetinib is a tyrosine kinase receptor inhibitor that is used in combination with vemurafenib as therapy for selected forms of advanced malignant melanoma. The combination of cobimetinib and vemurafenib is commonly associated with serum enzyme elevations during therapy and to rare instances of clinically apparent ac... | Cobimetinib (koe" bi me' ti nib) is a small molecule tyrosine kinase receptor inhibitor with potent activity against the mitogen-activated extracellular regulated kinase (MEK), which is an important component of the kinase cascade in the mitogen activated protein kinase (MAPK) pathway (RAS-RAF-MEK-ERK). Components of t... | Elevations in serum aminotransferase and alkaline phosphatase levels are common during vemurafenib therapy and are even more common when it is combined with cobimetinib, abnormal liver tests occurring in 26% to 70% of treated patients and ALT values rising above 5 times the upper limit of the normal range (ULN) in 6% t... | The cause of liver injury that occurs during therapy with MAPK pathway inhibitors is not well understood, but may relate to the direct effects of inhibition of these enzymes on hepatocytes. Cobimetinibb is metabolized in the liver via the cytochrome P450 system, predominantly CYP 3A and is susceptible to drug-drug inte... | Liver injury due to cobimetinib varies in severity from minor, transient serum enzyme elevations to acute symptomatic hepatitis. The product label for cobimetinib recommends monitoring of routine liver tests during treatment. Serum aminotransferase elevations above 5 times the upper limit of normal (if confirmed) shoul... | Cobimetinib – Cotellic® | Antineoplastic Agents | null |
Trilaciclib.nxml | Trilaciclib | 2023-10-17 | Trilaciclib is an intravenously administered, small molecule inhibitor of cyclin-dependent kinases 4 and 6, that is used to decrease chemotherapy-induced myelosuppression. Serum aminotransferase elevations arise in a small proportion of patients treated with the highest doses of trilaciclib, but episodes of clinically ... | Trilaciclib (trye” la sye’ klib) is a first-in-class, short acting inhibitor of cyclin-dependent kinases 4 and 6, that is used to prevent bone marrow suppression by anticancer therapies. Trilaciclib causes transient G1 cell cycle arrest in hematopoietic cells protecting them against the myelosuppression caused by cytot... | In the prelicensure clinical trials of trilaciclib in patients with advanced cancer receiving cytotoxic chemotherapy, serum AST elevations arose in 17% of trilaciclib vs 14% of placebo recipients. The AST elevations were usually self-limited and mild and elevations above 5 times the upper limit of normal (ULN) were unc... | The cause of serum aminotransferase elevations from trilaciclib is unknown, but the pattern of abnormalities suggests a minor degree of direct toxicity. Trilaciclib is metabolized in the liver via the cytochrome P450 system, largely by CYP 3A4 and to a lesser extent by CYP 2C8. Trilaciclib is susceptible to drug-drug i... | The product label for trilaciclib does not recommend regular monitoring of liver tests, but if serum aminotransferase levels above 5 times the ULN are identified, therapy should be held until levels fall into the normal or near normal range, at which point it can be started at the same or a reduced dose as clinically i... | Trilaciclib – Cosela® | Antineoplastic Agents | null |
Isavuconazonium.nxml | Isavuconazonium | 2018-04-27 | Isavuconazonium is a triazole antifungal agent used primarily in the treatment of invasive aspergillosis and mucormycosis infections. Isavuconazonium is associated with a low rate of transient and asymptomatic serum aminotransferase elevations during therapy, but has not been linked to instances of clinically apparent ... | Isavuconazonium (eye" sa vue koe" na zoe' nee um) is a synthetic triazole and prodrug of isavuconazole, the active moiety. Similar to other triazoles, such as voriconazole and itraconazole, isavuconazole is believed to act through inhibition of the fungal 14α-ergosterol demethylase that is responsible for converting la... | Transient elevations in serum aminotransferase levels occur in 1% to 5% of patients on isavuconazonium. These elevations are usually asymptomatic and self-limited, but occasional patients require discontinuation of isavuconazonium because of ALT elevations. Clinically apparent hepatotoxicity has not been reported with ... | The cause of clinically apparent hepatotoxicity from isavuconazonium is unknown; however, it may have some correlation with its ability to alter human sterol synthesis. Because isavuconazonium is a substrate for several P450 enzymes (CYP 3A4 and 3A5), it has the potential to cause significant drug-drug interactions, in... | The serum enzyme elevations attributed to isavuconazonium therapy are usually mild and transient and rarely require dose adjustment or discontinuation. Cases of clinically apparent liver injury have not been reported with isavuconazonium, but have been observed with other structurally similar antifungal triazoles. Ther... | Isavuconazonium – Cresemba® | Antifungal Agents | null |
Foscarnet.nxml | Foscarnet | 2018-02-06 | Foscarnet a simple pyrophosphate molecule which has antiviral activity against many viruses and is used intravenously in therapy of serious cytomegalovirus infections, largely in immunocompromised patients. Foscarnet has been associated with mild-to-moderate serum aminotransferase elevations during intravenous therapy,... | Foscarnet (fos kar' net) is a pyrophosphate (phosphonoformate) that has antiviral activity against several DNA viruses, including cytomegalovirus (CMV) and hepatitis B virus. Foscarnet appears to act by inhibition of the pyrophosphate binding sites of viral DNA polymerases. Foscarnet is poorly absorbed orally and must ... | Intravenous foscarnet therapy is associated with mild-to-moderate serum ALT elevations in a proportion of patients, but the drug is usually given to patients with multiorgan disease and conditions that may be associated with some degree of hepatic injury. The ALT elevations are usually asymptomatic and resolve even wit... | Foscarnet is rapidly excreted in the urine and has little hepatic metabolism, which may account for its relative lack of hepatotoxicity. Acute liver injury during foscarnet therapy might be a result of a hypersensitivity reaction to the drug or of a complication of the condition for which foscarnet was used. | The serum aminotransferase elevations during foscarnet therapy are usually self-limited and do not require dose adjustment. Foscarnet is usually given to severely immunocompromised patients who are frequently on multiple other medications, many of which may be hepatotoxic and attribution of hepatic injury in such indiv... | Foscarnet – Generic, Foscavir® | Antiviral Agents | null |
Nilutamide.nxml | Nilutamide | 2023-03-15 | Nilutamide is a first generation, oral nonsteroidal antiandrogen similar in structure to flutamide that is used in the therapy of prostate cancer. Nilutamide is associated with a low rate of serum aminotransferase elevations during therapy and with rare instances of clinically apparent, acute liver injury. | Nilutamide (nye loo' ta mide) is an anilide nonsteroidal antiandrogen that blocks the binding of endogenous androgens to intracellular androgen receptors blocking their effects. Nilutamide has been shown to be effective in reducing pain and disease progression in metastatic prostate cancer when administered in conjunct... | In large registration clinical trials, ALT elevations occurred in 8% (range 2% to 33%) of patients during nilutamide therapy. The elevations were usually mild, asymptomatic and transient, requiring drug discontinuation in only 1% of treated patients. In rare instances, clinically apparent acute liver injury has occurre... | The mechanism of nilutamide hepatotoxicity is unknown, but toxic metabolites of the agent may induce oxidative stress or interfere with mitochondrial function. | The mild ALT elevations during nilutamide therapy are usually self-limiting even with continuation of the medication. The rare instances of clinically apparent liver injury are usually self-limiting, but several fatal instances have been reported. Monitoring of liver tests is recommended before starting treatment and a... | Nilutamide – Generic, Nilandron® | Antineoplastic Agents | null |
Tizanidine.nxml | Tizanidine | 2017-01-30 | Tizanidine is a commonly used muscle relaxant that has been linked to rare instances of acute liver injury, a few of which have been fatal. | Tizanidine (tye zan' i deen) is an imidazoline derivative and is a centrally acting muscle relaxant used for therapy of acute muscle spasms and chronic spasticity. The mechanism by which tizanidine causes skeletal muscle relaxation is not well known; it appears to act at the level of spinal cord pain reflexes, most lik... | Transient and asymptomatic elevations in serum ALT greater than 3 times the upper limit of normal occur in ~5% of patients taking tizanidine compared to 0.4% of subjects on placebo. Reports of severe hepatotoxicity, acute liver failure and death have been mentioned in review articles on tizanidine, but few case reports... | The cause of acute hepatic injury from tizanidine is unknown, but is probably idiosyncratic due to hypersensitivity. | The idiosyncratic liver injury due to tizanidine ranges from hepatitis with jaundice to acute liver failure leading to death. Chronic injury and vanishing bile duct syndrome have not been reported after tizanidine therapy. Recurrence on re-exposure has been reported and rechallenge should be avoided. No cross reactivit... | Tizanidine – Generic, Zanaflex® | Autonomic Agents: Muscle Relaxants, Central | null |
FolicAcid.nxml | Folic Acid | 2018-02-06 | Folic acid is a water soluble vitamin found in many foods and particularly in leafy green vegetables that is essential for the critical biosynthetic pathways involving transfer of methyl groups to organic compounds. There is no evidence that folic acid, in physiologic or even super-physiologic, high doses, causes liver... | Folic acid (fo' lik a' cid) is the critical water soluble vitamin that plays an essential role in many biosynthetic pathways largely as a major donor of one-carbon molecules such as methyl groups. Folic acid is a pteroylglutamic acid, but it exists in several related congeners such as tetrahydrofolic acid (the activate... | Neither normal nor excessively high intakes of folate are associated with liver injury or liver test abnormalities. In long term clinical trials, serum enzyme and bilirubin elevations were no more frequent with folic acid therapy than with placebo. Use of high doses of folic acid (up to 15 mg daily) has not been associ... | It is not clear how folate might cause liver injury. Folate is stored in the liver, but it is metabolized in many tissues and has no effects on the hepatic microsomal enzyme systems.\n\nDrug Class: Vitamins\n\nOther Drugs in the Class: Vitamin A, Vitamin B, Vitamin C, Vitamin D, Vitamin E, Vitamin K, Niacin | null | Folic Acid – Generic, Combination Products (some include leucovorin) | Vitamins | [
{
"cas_registry_number": "59-30-3",
"molecular_formula": "C19-H19-N7-O6",
"name": "Folic Acid"
},
{
"cas_registry_number": "58-05-9",
"molecular_formula": "C20-H23-N7-O7",
"name": "Leucovorin"
}
] |
Rofecoxib.nxml | Rofecoxib | 2020-03-20 | Rofecoxib is a nonsteroidal antiinflammatory drug (NSAID) that selectively inhibits cyclooxgenase-2 (Cox-2), which was used in the therapy of chronic arthritis and mild-to-moderate musculoskeletal pain. Rofecoxib was withdrawn in 2004 because of an association with an increase in cardiovascular events with its long ter... | Rofecoxib (roe" fe kox' ib) is a nonsteroidal antiinflammatory drug that acts through selective inhibition of cyclooxgenase-2 resulting in decreased prostaglandin synthesis and thereby decreasing inflammation, fever and pain. The specificity for Cox-2 is believed to make rofecoxib less likely to cause gastrointestinal ... | In clinical studies involving several thousand patients treated for at least 3 months, the rate of serum aminotransferase enzyme elevations above three times the upper limit of the normal range was 1.8% in rofecoxib treated compared to 0.3% in placebo treated patients and 0.1-0.4% in patients receiving other common NSA... | The cause of acute hepatic injury from rofecoxib is unknown. The clinical pattern of injury resembles that of other NSAID induced liver injury. | The idiosyncratic liver injury due to rofecoxib can lead to prolonged jaundice, but has not been associated with acute liver failure or vanishing bile duct syndrome. In the few cases that have been described, the time to recovery has varied greatly, but is usually 1 to 3 months. Rechallenge should be avoided, but there... | Rofecoxib – Vioxx® | Nonsteroidal Antiinflammatory Drugs | null |
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