Prescription medicine
Tolcapone Brand names: Tasmar
Tolcapone (Tasmar) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the tolcapone FDA label on DailyMed (effective October 2, 2020, Bausch Health US LLC); the NDA 20697 record on Drugs@FDA; every tolcapone label on DailyMed.
Highlights of the record
FDA label of October 2, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 (see INDICATIONS and DOSAGE AND ADMINISTRATION sections). 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the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from TASMAR. TASMAR therapy should not be initiated if the patient exhibits clinical evidence of liver disease or two SGPT/ALT or SGOT/AST values greater than the upper limit of normal. Patients with severe dyskinesia or dystonia should be treated with caution (see PRECAUTIONS: Rhabdomyolysis ). PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON TASMAR AND ARE WITHDRAWN FROM THE DRUG FOR ANY REASON MAY BE AT INCREASED RISK FOR LIVER INJURY IF TASMAR IS REINTRODUCED. ACCORDINGLY, SUCH PATIENTS SHOULD NOT ORDINARILY BE CONSIDERED FOR RETREATMENT. Cases of severe hepatocellular injury, including fulminant liver failure resulting in death, have been reported in postmarketing use. […]
Used for
From the label: indications and usageTASMAR is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
Forms and strengths
- 100 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- January 29, 1998 Tasmar, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first March 26, 2015; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 349 through July 30, 2026
What is tolcapone used for?
From the label: indications and usageTASMAR 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. […]
Conditions named in the indications of tolcapone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Catechol-O-Methyltransferase Inhibitor.
Source: FDA drug label (Tasmar), Bausch Health US LLC, effective October 2, 2020 (SPL set a0e47a9d-78e7-4523-983a-aa259f221736), via openFDA; the full label on DailyMed
Is there a generic for tolcapone (Tasmar)?
The FDA approved the first generic tolcapone on March 26, 2015. 4 generic applications are approved; 0 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tolcapone from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1998 earliest approval on file
- 2015 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tolcapone label say about other medicines?
The tolcapone label names 16 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name tolcapone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Apomorphine | drug interactions | The effect of tolcapone on the pharmacokinetics of other drugs of this class such as α-methyldopa, dobutamine, apomorphine, and isoproterenol has not been evaluated. |
| Caffeine | drug interactions | No relevant interactions with substrates for CYP 2A6 (warfarin), CYP 1A2 (caffeine), CYP 3A4 (midazolam, terfenadine, cyclosporine), CYP 2C19 (S-mephenytoin) and CYP 2D6 (desipramine) were observed in vitro. |
| Carbidopa | boxed warning | WARNING 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 … |
| Carbidopa and levodopa | drug interactions | When TASMAR was given together with levodopa/carbidopa and desipramine, there was no significant change in blood pressure, pulse rate and plasma concentrations of desipramine. |
| Cyclosporine | drug interactions | No relevant interactions with substrates for CYP 2A6 (warfarin), CYP 1A2 (caffeine), CYP 3A4 (midazolam, terfenadine, cyclosporine), CYP 2C19 (S-mephenytoin) and CYP 2D6 (desipramine) were observed in vitro. |
| Desipramine | drug interactions | When TASMAR was given together with levodopa/carbidopa and desipramine, there was no significant change in blood pressure, pulse rate and plasma concentrations of desipramine. |
| Dobutamine | drug interactions | The effect of tolcapone on the pharmacokinetics of other drugs of this class such as α-methyldopa, dobutamine, apomorphine, and isoproterenol has not been evaluated. |
| Ephedrine | drug interactions | Drugs That Increase Catecholamines: Tolcapone did not influence the effect of ephedrine, an indirect sympathomimetic, on hemodynamic parameters or plasma catecholamine levels, either at rest or during exercise. |
| Isoproterenol | drug interactions | The effect of tolcapone on the pharmacokinetics of other drugs of this class such as α-methyldopa, dobutamine, apomorphine, and isoproterenol has not been evaluated. |
| Levodopa | drug interactions | In clinical trials, patients receiving TASMAR/levodopa preparations reported a similar adverse event profile independent of whether or not they were also concomitantly administered selegiline (a selective MAO-B inhibitor). |
| Midazolam | drug interactions | No relevant interactions with substrates for CYP 2A6 (warfarin), CYP 1A2 (caffeine), CYP 3A4 (midazolam, terfenadine, cyclosporine), CYP 2C19 (S-mephenytoin) and CYP 2D6 (desipramine) were observed in vitro. |
| Phenelzine | warnings | It is theoretically possible, therefore, that the combination of TASMAR and a non-selective MAO inhibitor (e.g., phenelzine and tranylcypromine) would result in inhibition of the majority of the pathways responsible for normal catecholamine metabolism. |
| Phenytoin | drug interactions | The experiments included warfarin (0.5 to 7.2 mcg/mL), phenytoin (4.0 to 38.7 mcg/mL), tolbutamide (24.5 to 96.1 mcg/mL) and digitoxin (9.0 to 27.0 mcg/mL). |
| Selegiline | drug interactions | In clinical trials, patients receiving TASMAR/levodopa preparations reported a similar adverse event profile independent of whether or not they were also concomitantly administered selegiline (a selective MAO-B inhibitor). |
Every other medicine the tolcapone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Tranylcypromine | warnings | It is theoretically possible, therefore, that the combination of TASMAR and a non-selective MAO inhibitor (e.g., phenelzine and tranylcypromine) would result in inhibition of the majority of the … |
| Warfarin | drug interactions | Due to its affinity to cytochrome P450 2C9 in vitro, tolcapone may interfere with drugs, whose clearance is dependent on this metabolic pathway, such as tolbutamide and warfarin. |
Source: FDA drug label (Tasmar), Bausch Health US LLC, effective October 2, 2020 (SPL set a0e47a9d-78e7-4523-983a-aa259f221736), via openFDA; the full label on DailyMed
What do FAERS reports show for tolcapone?
The FDA Adverse Event Reporting System holds 349 reports that list tolcapone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 62 are coded as a death and 170 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tolcapone?
13 other medicines are given the same way (oral) and in the same FDA class as tolcapone or labeled mainly for the same use (parkinson's disease), the same class first. Parkinson's disease lists all 19 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Carbidopa and entacapone and levodopa | Parkinson's disease | 4 labelers | $0.695 per tablet 25-100-200 mg tablet | No current entry |
| Entacapone | Parkinson's disease | 11 labelers | $0.325 per tablet 200 mg tablet | No current entry |
| Opicapone | Parkinson's disease | none listed | $24.67 per capsule 25 mg capsule | No current entry |
| Ropinirole | Parkinson's disease | 27 labelers | $0.046 per tablet 0.25 mg tablet | No current entry |
| Pramipexole | Parkinson's disease | 22 labelers | $0.0452 per tablet 0.25 mg tablet | No current entry |
| Carbidopa and levodopa | Parkinson's disease | 33 labelers | $0.0759 per tablet 25-100 tablet | No current entry |
| Benztropine | Parkinson's disease | 19 labelers | $0.0753 per tablet 1 mg tablet | A presentation being discontinued |
| Rasagiline | Parkinson's disease | 14 labelers | $0.521 per tablet 0.5 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to tolcapone
- 13 medicines for the same use
- Other catechol-o-methyltransferase inhibitors
- the pharmacologic class, with prices and generics
- Tolcapone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other