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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Last Update: July 20, 2017.



Entacapone is a catechol-O-methyltransferase inhibitor used in the therapy of Parkinson disease as adjunctive therapy in combination with levodopa and carbidopa. Entacapone has been associated with a low rate of serum enzyme elevations during treatment, but has yet to be implicated in cases of clinically apparent acute liver injury with jaundice.


Entacapone (en tak' a pone) is a specific inhibitor of cathechol-O-methyltransferase (COMT) which is a major enzyme in the pathway of levodopa metabolism. As a result, entacapone slows the metabolism of levodopa, causing an increase in its bioavailability and duration of action. Entacapone inhibits COMT activity only peripherally, unlike tolcapone which acts both peripherally and centrally. Entacapone was approved for use in the United States in 2003, the second COMT inhibitor approved for use in the therapy of symptomatic Parkinson disease as an adjunct to levodopa/carbidopa therapy in patients with motor complications. Entacapone is available in tablets of 200 mg generically and under the brand name of Comtan. It is also available in several fixed dose combinations with carbidopa and levodopa generically and under the brand name Stalevo. Entacapone is typically initiated in doses of 200 mg with each dose of levodopa/carbidopa to a maximum of 1600 mg daily. Common side effects include somnolence, dizziness, confusion, dyskinesia, vivid dreams, hallucinations, depression, fatigue, headache, diarrhea and gastrointestinal upset, side effects that are largely due to enhancement of the dopaminergic effects of levodopa.


Entacapone therapy has been associated with serum aminotransferase elevations (above 3 times the upper limit of normal) in only 0.3 to 0.5% of patients, which is similar or minimally higher than the rate in subjects receiving placebo. The elevations were usually transient and asymptomatic and rarely required dose adjustment. In preliminary clinical trials, there were no reports of clinically apparent serious liver injury with jaundice. Subsequently, isolated instances of hepatotoxicity have been reported, injury arising 2 to 6 weeks after starting entacapone with mild jaundice and cholestatic pattern of liver enzyme elevations, and rapid recovery on stopping. Immunoallergic and autoimmune features were not present. Thus, entacapone may rarely cause clinically apparent liver injury, but it has not been associated with the severe hepatitis and acute liver failure that characterized cases of tolcapone inudced liver injury.

Likelihood score: D (possible, rare cause of clinically apparent liver injury).

Mechanism of Injury

Entacapone is extensively metabolized by the liver and eliminated though biotransformation, mostly by glucuronidation via UDP-glucuronosyl transferase. Polymorphisms of this enzyme have been linked to liver enzyme elevations during therapy, but the relationship between dose, metabolism and liver injury due to entacapone has not been defined.

Outcome and Management

The cases of hepatotoxicity attributed to entacapone have been mild and self-limiting. There have been no reports of acute liver failure, chronic liver injury or vanishing bile duct syndrome associated with entacapone therapy. In at least one case report, a patient who developed raised serum enzymes during tolcapone therapy, redeveloped enzyme elevations after being switched to entacapone. Otherwise, the liver injury associated with these two COMT inhibitors has been distinct, without evidence of a class effect.

Drug Class: Antiparkinson Agents

Other Drugs in the Subclass, COMT Inhibitors: Tolcapone



Entacapone – Generic, Comtan®


Antiparkinson Agents


Product labeling at DailyMed, National Library of Medicine, NIH


Entacapone Chemical Structure


References updated: 20 July 2017

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    (Randomized controlled trial of replacing entacapone with tolcapone in patients with Parkinson disease and motor fluctuations on long term levodopa therapy; ALT elevations occurred in 3% on entacapone and 9% on tolcapone, but were mild and self-limiting).
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    (Controlled trial of tolcapone vs placebo combined with levodopa and carbidopa in 677 patients with early Parkinson disease; ALT or AST elevations occurred in 20% of placebo- vs 27% of tolcapone treated patients and were >3 times ULN in 1.2% [placebo] vs 1.8% [tolcapone], almost all during first 6 months; 1% of tolcapone treated patients stopped because of ALT elevations, but none developed jaundice or clinically apparent liver injury).
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    (Design and early results of a comprehensive study of rats given 28 days of entacapone or tolcapone as examples of two related agents, one of which causes liver injury in man and one which does not, assessing liver enzymes, histology, gene transcription, proteomics, metabolomics and possible biomarkers to identify predictors of idiosyncratic liver injury in humans).
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    (Among 1198 patients with acute liver failure enrolled in a US prospective study between 1998 and 2007, 133 were attributed to drug induced liver injury but none were attributed to agents used for Parkinson disease).
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    (In vitro study of binding of tolcapone and entacapone to other proteins; unlike entacapone, tolcapone interacted with a number of non-COMT intracellular proteins which are involved in the respiratory chain actions, fatty acid beta-oxidation and bile acid synthesis, perhaps accounting for its potential for hepatotoxicity).
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    (Extensive review of the mechanism of hepatic injury from tolcapone; "at the moment there is no explanation to the hepatotoxicity appeared in clinical use").
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    (Systematic review of literature on safety and efficacy of tolcapone and entacapone recommends use of tolcapone only if entacapone treatment fails and liver tests are normal).
  • McBurney RN, Hines WM, VonTungeln LS, Schnackenberg LK, Beger RD, Moland CL, Han T, et al. The liver toxicity biomarker study phase I: markers for the effects of tolcapone or entacapone. Toxicol Pathol 2012; 40: 951-64. [PubMed: 22573522]
    (Comparison of the molecular effects of tolcapone vs entacapone on rat liver and plasma biomarkers found that changes from the two drugs only partially overlapped and different effects were present at 3 and 28 days, suggesting that some of these "off-target" and specific effects of tolcapone may account for its occasional hepatotoxicity).
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    (In a population based study of drug induced liver injury from Iceland, 96 cases were identified over a 2 year period, but none of the 96 were attributed to an agent used to treat Parkinson disease).
  • Drugs for Parkinson's disease. Treat Guidel Med Lett 2013; 11 (135): 101-6. [PubMed: 24165688]
    (Concise review of recommendations for therapy of Parkinson disease with description of mechanisms of action, efficacy and adverse events).
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    (Among 176 reports of drug induced liver injury from Latin America published between 1996 and 2012, none were attributed to an agent to treat Parkinson disease).
  • Eggert K, Oertel WH, Lees AJ; German Competence Network on Parkinson’s disease. Safety and efficacy of tolcapone in the long-term use in Parkinson disease: an observational study. Clin Neuropharmacol 2014; 37: 1-5. [PubMed: 24434524]
    (Among 391 patients with Parkinson disease treated with tolcapone in an observation study conducted at 48 neurologic centers and followed for one year, 34 [8.7%] developed liver enzyme elevation, usually within the first 3 months, which were above twice ULN in only 5 [1.3%] and resolved spontaneously in most; no patient developed clinically apparent liver injury).
  • Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al.; United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology 2015; 148: 1340-52. [PMC free article: PMC4446235] [PubMed: 25754159]
    (Among 899 cases of drug induced liver injury from the US enrolled in a prospective database between 2004 and 2012, none were attributed to an agent used to treat Parkinson disease).
  • Longo DM, Yang Y, Watkins PB, Howell BA, Siler SQ. Elucidating differences in the hepatotoxic potential of tolcapone and entacapone with DILIsym(®), a mechanistic model of drug-induced liver injury. CPT Pharmacometrics Syst Pharmacol 2016; 5 (1): 31-9. [PMC free article: PMC4728295] [PubMed: 26844013]
    (Description of mechanistic simulation models of the metabolism and toxicity of tolcapone and entacapone which predicted their differential hepatotoxicity).
  • Lv X, Wang XX, Hou J, Fang ZZ, Wu JJ, Cao YF, Liu SW, et al. Comparison of the inhibitory effects of tolcapone and entacapone against human UDP-glucuronosyl-transferases. Toxicol Appl Pharmacol 2016; 301: 42-9. [PubMed: 27089846]
    (Comparison of the inhibitory effects of tolacapone and entacapone against recombinant human UGTs showed more potent inhibtion by tolacapone for most isoforms).


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