Anpheros Search · Treatment

Tolcapone

Also known as: Tasmar

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In short

In the European Union, tolcapone is indicated in combination with levodopa/benserazide or levodopa/carbidopa for patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations who have failed to respond to or are intolerant of other catechol-O-methyltransferase inhibitors. Because of the risk of potentially fatal, acute liver injury, it should not be considered as a first-line adjunct therapy in the European Union. In the United States, tolcapone is indicated as an adjunct to levodopa and carbidopa for treating the signs and symptoms of idiopathic Parkinson's disease. Due to the risk of potentially fatal, acute fulminant liver failure, its use in the United States is ordinarily for patients experiencing symptom fluctuations who do not respond satisfactorily to or are not appropriate candidates for other adjunctive therapies.

From: Source: European Medicines Agency (EMA), Tasmar — EPAR, 10/09/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
72937 tolcapone
EMA
EMEA/H/C/000132

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Tasmar

Tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase (COMT) inhibitors. Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa. Since Tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.

Source: European Medicines Agency (EMA), Tasmar — EPAR, 10/09/2025. © European Medicines Agency.

Document date: 10/09/2025 · Official document →

FDA (USA) Tasmar

INDICATIONS: TASMAR is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Because of the risk of potentially fatal, acute fulminant liver failure, TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. Because of the risk of liver injury and because TASMAR, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from TASMAR. The effectiveness of TASMAR was demonstrated in randomized controlled trials in patients receiving concomitant levodopa therapy with carbidopa or another aromatic amino acid decarboxylase inhibitor who experienced end of dose wearing-off phenomena as well as in patients who did not experience such phenomena (see CLINICAL PHARMACOLOGY: Clinical Studies ).

Data provided by the U.S. Food and Drug Administration.

Document date: 20201002 · Official document →

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External resources

Questions

What is Tolcapone approved for in the European Union?

Tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase (COMT) inhibitors. Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa. Since Tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar. (Source: European Medicines Agency (EMA), Tasmar — EPAR, 10/09/2025. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Tasmar — EPAR, 10/09/2025. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →