Tolcapone
Tasmar · ATC code N04BX01
Also known as: Tolcapon, Tolkapon
- Key facts
- Active substance
- Tolcapone
- Drug class
- Dopaminergic
- ATC code
- N04BX01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Tasmar 100 mg film-coated tablets · Tasmar 200 mg film-coated tablets
- Marketing authorisation holder
- Viatris Healthcare Limited
- Information as of
- 2026-10-29
Key facts
Tolcapone is a catechol-O-methyltransferase (COMT) inhibitor used as an adjunct to levodopa in Parkinson's disease with motor fluctuations (Tasmar).
What it is used for
- In combination with levodopa/benserazide or levodopa/carbidopa in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations who failed to respond to or are intolerant of other COMT inhibitors.
- Because of the risk of potentially fatal acute liver injury, not a first-line adjunct therapy.
Dosing
- Recommended dose 100 mg three times daily, always with levodopa; the first daily dose with the first levodopa dose, the others approximately 6 and 12 hours later.
- Only in exceptional circumstances 200 mg three times daily (maximum); discontinue if substantial benefit is not seen within 3 weeks.
- Liver function before starting, every 2 weeks in the first year, every 4 weeks for the next 6 months and every 8 weeks thereafter; discontinue if ALT and/or AST exceed the upper limit of normal.
- Levodopa dose reduction is often needed (in trials more than 70% of patients with daily levodopa >600 mg or dyskinesias).
- No dose adjustment in the elderly or mild to moderate renal impairment; contraindicated in liver disease.
Contraindications
- Hypersensitivity to tolcapone or any other ingredient.
- Evidence of liver disease or increased liver enzymes.
- Severe dyskinesia.
- History of neuroleptic malignant syndrome, non-traumatic rhabdomyolysis or hyperthermia.
- Phaeochromocytoma; treatment with non-selective MAO inhibitors.
Important warnings
- Rare but potentially fatal acute liver injury, most often between 1 and 6 months after starting; female patients may have a higher risk.
- Diarrhoea (16% and 18% with 100 mg and 200 mg three times daily), usually starting 2 to 4 months after initiation.
- Monitor for impulse control disorders.
- Only by physicians experienced in advanced Parkinson's disease, after a complete discussion of the risks.
Side effects
- Dopaminergic effects from increased levodopa availability: increased dyskinesia, nausea, vomiting, abdominal pain, syncope, orthostatic complaints, constipation, sleep disorders, somnolence, hallucination.
- Diarrhoea was the only adverse reaction commonly leading to discontinuation.
- Rare but potentially fatal liver injury.
Interactions
- Increases the bioavailability of levodopa.
- Contraindicated with non-selective MAO inhibitors; caution with potent noradrenaline uptake inhibitors (e.g. desipramine, maprotiline, venlafaxine).
- With warfarin, monitor coagulation parameters.
Pregnancy and breastfeeding
- Use in pregnancy only if the benefit justifies the risk to the foetus.
- Women should not breast-feed during treatment.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- TasmarViatris Healthcare Limited · EMEA/H/C/000132
Source: European Medicines Agency (EMA), product information
Germany
- Tolcapon NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- TasmarVİATRİS İLAÇLARI LİMİTED ŞİRKETİ · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Tasmar
- Liechtenstein
- Tasmar
- Norway
- Tasmar
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Tasmar – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/tasmar-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC N04BX.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.