Uses
Ropinirole Tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS).
Source: US FDA prescribing information
- Presentations
- 12
- Brands
- 0
- Manufacturers
- 0
- Available from stock
- 0
Ropinirole is a nonergot dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS), among other approved uses. It is available as tablets and extended-release tablets for oral use. MedsAcross supplies Ropinirole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Nonergot Dopamine Agonist, Dopamine Agonists
- ATC classification
- N04BC04 Ropinirole · Dopamine agonist
- US FDA first approval
- 19 September 1997
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Tablet, Extended-release tablet
- Identifiers
- UNII 030PYR8953RxCUI 72302CAS 91374-21-9DrugBank DB00268Q420590
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Ropinirole is a non-ergoline dopamine agonist. The precise mechanism of action of ropinirole as a treatment for Parkinson’s disease is unknown, although it is thought to be related to its ability to stimulate dopamine D2 receptors within the caudate-putamen in the brain. The precise mechanism of action of ropinirole as a treatment for RLS is unknown, although it is thought to be related to its ability to stimulate dopamine receptors.
Source: US FDA prescribing information
Dosing overview
• Ropinirole tablets can be taken with or without food. • Retitration of ropinirole tablets may be warranted if therapy is interrupted. Parkinson’s Disease: • The recommended starting dose is 0.25 mg taken three times daily, titrate to a maximum daily dose of 24 mg. • Renal Impairment: The maximum recommended dose is 18 mg/day in patients with end-stage renal disease on hemodialysis. Restless Legs Syndrome: • The recommended starting dose is 0.25 mg once daily, 1 to 3 hours before bedtime, titrate to a maximum recommended dose of 4 mg daily. • Renal Impairment: The maximum recommended dose is 3 mg/day in patients with end-stage renal disease on hemodialysis.
Source: US FDA prescribing information
Contraindications
Ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. History of hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients
Source: US FDA prescribing information
Warnings and precautions
• Sudden onset of sleep and somnolence may occur. • Syncope may occur. • Hypotension, including orthostatic hypotension may occur. • May cause hallucinations and psychotic-like behaviors. • May cause or exacerbate dyskinesia. • May cause problems with impulse control or compulsive behaviors
Source: US FDA prescribing information
Side effects
The following adverse reactions are described in more detail in other sections of the label: Hypersensitivity Falling asleep during activities of daily living and somnolence Syncope Hypotension/orthostatic hypotension Hallucinations/psychotic-like behavior Dyskinesia Impulse control/compulsive behaviors Withdrawal-emergent hyperpyrexia and confusion Withdrawal Symptoms Augmentation and early-morning rebound in RLS Fibrotic complications Retinal pathology Most common adverse reactions (incidence with ropinirole tablets at least 5% greater than placebo) in the respective indications were: Early PD: Nausea, somnolence, dizziness, syncope, asthenic condition, viral infection, leg edema, vomiting, and dyspepsia. Advanced PD: Dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, sweating, and headache. RLS: Nausea, vomiting, somnolence, dizziness, and asthenic condition.
Source: US FDA prescribing information
Interactions
• Inhibitors or inducers of CYP1A2: May alter the clearance of ropinirole tablets, dose adjustment of ropinirole tablets may be required. • Hormone replacement therapy(HRT): Starting or stopping HRT may require dose adjustment of ropinirole tablets. • Dopamine antagonists (e.g., neuroleptics, metoclopramide): May reduce efficacy of ropinirole tablets
Source: US FDA prescribing information
Storage
Store at controlled room temperature 20° to 25°C (68° to 77°F),.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
12 presentations of Ropinirole, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ropinirole 1 mg tabletOralGeneric name | — | US FDA | Available on request |
| Ropinirole 0.25 mg tabletOralGeneric name | — | US FDA | Available on request |
| Ropinirole 0.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Ropinirole 2 mg tabletOralGeneric name | — | US FDA | Available on request |
| Ropinirole 4 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Ropinirole 8 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Ropinirole 12 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Ropinirole 2 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Ropinirole 6 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Ropinirole 3 mg tabletOralGeneric name | — | US FDA | Available on request |
| Ropinirole 4 mg tabletOralGeneric name | — | US FDA | Available on request |
| Ropinirole 5 mg tabletOralGeneric name | — | US FDA | Available on request |
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 19 September 1997 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Ropinirole in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Ropinirole available for export from India?
Yes, on request. MedsAcross lists 12 presentations of Ropinirole and sources them for licensed hospitals, importers and physicians against valid import documents.
Is Ropinirole approved by the US FDA?
Yes. The US FDA first approved Ropinirole on 19 September 1997, according to Drugs@FDA.
Does Ropinirole need cold chain shipping?
No listed presentation of Ropinirole is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Ropinirole in?
Ropinirole is classified under ATC code N04BC04 (Ropinirole).
References
- ROPINIROLE prescribing information (Alembic Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 2 September 2026
Request Ropinirole for export supply
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.