Prescription medicine
Entacapone First approved as Comtan
Entacapone (Comtan) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $0.325 per entacapone 200 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the entacapone FDA label on DailyMed (effective November 30, 2023, Sandoz Inc); the NDA 20796 record on Drugs@FDA; every entacapone label on DailyMed.
Highlights of the record
FDA label of November 30, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageEntacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies).
Forms and strengths
- 200 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- October 19, 1999 Comtan, Orion Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first July 16, 2012; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 11 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.325 per tablet Entacapone 200 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest July 29, 2021
- FAERS reports
- 4,154 through July 30, 2026
What is entacapone used for?
From the label: indications and usageEntacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Entacapone tablet’s effectiveness has not been systematically evaluated in patients with Parkinson’s disease who do not experience end-of-dose “wearing-off”.
Conditions named in the indications of entacapone's FDA labels, with every medicine labeled for each:
From other entacapone labelsParkinson's disease: INDICATIONS Entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies).
FDA pharmacologic class: Catechol-O-Methyltransferase Inhibitor.
Source: FDA drug label (Entacapone), NDA020796 (Orion Pharma), as published by Sandoz Inc, effective November 30, 2023 (SPL set ad4b6d79-efd3-4c43-b4dc-5afdacf939a4), via openFDA; the full label on DailyMed
Is there a generic for entacapone (Comtan)?
The FDA approved the first generic entacapone on July 16, 2012. 8 generic applications are approved; 7 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 entacapone from 11 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for entacapone (Comtan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.325 per Entacapone 200 mg tablet, down 3% from $0.335 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Entacapone 200 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Entacapone 200 mg tablet | Generic | $0.325 per tablet | $9.74 | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has entacapone been recalled?
The FDA's Enforcement Report lists 1 recall naming entacapone since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 29, 2021 | Class II | The Harvard Drug Group | Failed Dissolution Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the entacapone label say about other medicines?
The entacapone label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name entacapone. 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 | warnings | Therefore, drugs known to be metabolized by COMT, such as isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine, isoetherine and bitolterol should be administered with caution in patients receiving entacapone regardless of the route of administration (including inhalation), as … |
| Dobutamine | warnings | Therefore, drugs known to be metabolized by COMT, such as isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine, isoetherine and bitolterol should be administered with caution in patients receiving entacapone regardless of the route of administration (including inhalation), as … |
| Epinephrine | warnings | Drugs Metabolized By Catechol-O-Methyltransferase (COMT) When a single 400 mg dose of entacapone was given with intravenous isoprenaline (isoproterenol) and epinephrine without coadministered levodopa and dopa decarboxylase inhibitor, the overall mean maximal changes in heart rate during infusion were about 50% and … |
| Isoproterenol | warnings | Drugs Metabolized By Catechol-O-Methyltransferase (COMT) When a single 400 mg dose of entacapone was given with intravenous isoprenaline (isoproterenol) and epinephrine without coadministered levodopa and dopa decarboxylase inhibitor, the overall mean maximal changes in heart rate during infusion were about 50% and … |
| Levodopa | warnings | Drugs Metabolized By Catechol-O-Methyltransferase (COMT) When a single 400 mg dose of entacapone was given with intravenous isoprenaline (isoproterenol) and epinephrine without coadministered levodopa and dopa decarboxylase inhibitor, the overall mean maximal changes in heart rate during infusion were about 50% and … |
| Phenelzine | warnings | It is theoretically possible, therefore, that the combination of entacapone 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. |
| Propranolol | warnings | Treatment with propranolol was required. |
| Selegiline | warnings | Entacapone can be taken concomitantly with a selective MAO-B inhibitor (e.g., selegiline). |
| Tranylcypromine | warnings | It is theoretically possible, therefore, that the combination of entacapone 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. |
Source: FDA drug label (Entacapone), NDA020796 (Orion Pharma), as published by Sandoz Inc, effective November 30, 2023 (SPL set ad4b6d79-efd3-4c43-b4dc-5afdacf939a4), via openFDA; the full label on DailyMed
What do FAERS reports show for entacapone?
The FDA Adverse Event Reporting System holds 4,154 reports that list entacapone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 639 are coded as a death and 1,413 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.
Reports received each year
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 entacapone?
12 other medicines are given the same way (oral) and in the same FDA class as entacapone 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 |
|---|---|---|---|---|
| Tolcapone | Parkinson's disease | 1 labeler | n/a | 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 |
| Trihexyphenidyl | Parkinson's disease | 8 labelers | $0.0884 per tablet 2 mg tablet | No current entry |
Every medicine labeled for the same conditions as entacapone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to entacapone
- 12 medicines for the same use
- Other catechol-o-methyltransferase inhibitors
- the pharmacologic class, with prices and generics
- Entacapone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other