FDA label
What is ropinirole used for?
The FDA-approved uses of ropinirole, 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: “Parkinson’s Disease Ropinirole Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of Ropinirole Tablets were demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL ...”
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Ropinirole, tablet, film coated
Indications and Usage, quoted from the label by Alembic Pharmaceuticals Limited (ANDA090429). Cross-references to other label sections are left out.
Parkinson’s Disease Ropinirole Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of Ropinirole Tablets were demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials). Restless Legs Syndrome Ropinirole Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.
Source: DailyMed label, set id 9a25f575-09ab-4d32-b73e-5426f08c00c4, version 5, effective July 1, 2025. NDC 46708-030, one of 109 listings for this product.
Ropinirole, tablet, film coated, extended release
Indications and Usage, quoted from the label by Actavis Pharma, Inc. (ANDA090869). Cross-references to other label sections are left out.
Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.
Source: DailyMed label, set id 300946bf-2f83-471d-868d-9820b65c52bb, version 20, effective August 1, 2023. NDC 0228-3640, one of 25 listings for this product.
Questions
What is ropinirole used for?
The FDA label says: “Parkinson’s Disease Ropinirole Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. The effectiveness of Ropinirole Tablets were demonstrated in randomized, controlled trials in patients with early Parkinson’s disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL ...”
What drug class is ropinirole?
FDA lists ropinirole in the Nonergot Dopamine Agonist 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.