FDA label
What is entacapone used for?
The FDA-approved uses of entacapone, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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).”
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Entacapone, tablet, film coated
Indications and Usage, quoted from the label by Alembic Pharmaceuticals Limited (ANDA212601). Cross-references to other label sections are left out.
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).
Entacapone tablets effectiveness has not been systematically evaluated in patients with Parkinson’s disease who do not experience end-of-dose “wearing-off”.
Source: DailyMed label, set id d21ce241-b05a-413e-b19a-249ae42012a8, version 2, effective January 9, 2024. NDC 46708-478, one of 8 listings for this product.
Questions
What is entacapone used for?
The FDA label says: “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).”
What drug class is entacapone?
FDA lists entacapone in the Catechol-O-Methyltransferase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.