Prescription medicine
Ropinirole First approved as Requip
Ropinirole (Requip) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 26 generic labelers, and pharmacies paid $0.046 per ropinirole HCl 0.25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ropinirole FDA label on DailyMed (effective January 16, 2026, Glenmark Pharmaceuticals Inc., USA); the NDA 20658 record on Drugs@FDA; every ropinirole label on DailyMed.
Highlights of the record
FDA label of January 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRopinirole 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).
Forms and strengths
- 0.25 mg
- 0.5 mg
- 1 mg
- 2 mg
- 3 mg
- 4 mg
- 5 mg
- 6 mg
- 8 mg
- 12 mg
Film-coated tablet; film-coated extended-release tablet; extended-release tablet.
On the market
- Earliest approval on file
- September 19, 1997 Requip, Glaxosmithkline Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 21 first May 5, 2008; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 26 of which 26 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.046 per tablet Ropinirole HCl 0.25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 13 since 2013 0 Class I among all firms' recalls; latest March 20, 2023
- FAERS reports
- 18,695 through July 30, 2026
What is ropinirole used for?
From the label: indications and usageRopinirole 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). ( 1.1 , 1.2 ) 1.1 Parkinson's Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Conditions named in the indications of ropinirole's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nonergot Dopamine Agonist.
Source: FDA drug label (ropinirole), Glenmark Pharmaceuticals Inc., USA, effective January 16, 2026 (SPL set 85971b31-6f7d-421c-bf3c-5b33f3c1e781), via openFDA; the full label on DailyMed
What does the patient leaflet for ropinirole say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ropinirole tablets?Ropinirole tablets can cause serious side effects, including: • Falling asleep during normal activities. You may fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking ropinirole tablets. You may suddenly fall asleep without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while doing normal activities while taking ropinirole tablets are greater if you take other medicines that cause drowsiness. Tell your healthcare provider right away if this happens. Before starting ropinirole tablets, be sure to tell your healthcare provider if you take any medicines that make you drowsy. • Fainting. Fainting can happen, and sometimes your heart rate may be decreased. This can happen especially when you start taking ropinirole tablets or your dose is increased. Tell your healthcare provider if you faint, feel dizzy, or feel light-headed. • Decrease in blood pressure. Ropinirole tablets can decrease your blood pressure (hypotension), especially when you start taking ropinirole tablets or when your dose is changed. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down (orthostatic hypotension), this may mean that your blood pressure is decreased. When you change position from lying down or sitting to standing up, you should do it carefully and slowly. Call your healthcare provider if you have any of the symptoms of decreased blood pressure listed above. • Increase in blood pressure. Ropinirole extended-release tablets may increase your blood pressure. • Changes in heart rate (decrease or increase). Ropinirole tablets can decrease or increase your heart rate. • Hallucinations and other psychotic-like behavior. […]
From the patient leaflet: How should I store ropinirole tablets?Store ropinirole tablets at room temperature between 68°F and 77°F (20°C and 25°C). • Keep ropinirole tablets in a tightly closed container and out of direct sunlight. Keep ropinirole tablets and all medicines out of the reach of children.
Source: FDA drug label (ropinirole), Glenmark Pharmaceuticals Inc., USA, effective January 16, 2026 (SPL set 85971b31-6f7d-421c-bf3c-5b33f3c1e781), via openFDA; the full label on DailyMed
Is there a generic for ropinirole (Requip)?
The FDA approved the first generic ropinirole on May 5, 2008. 21 generic applications are approved; 15 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 ropinirole from 26 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.
- 1997 earliest approval on file
- 2008 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 ropinirole (Requip)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.046 per Ropinirole HCl 0.25 mg tablet, down 3% from $0.0473 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Ropinirole HCl 0.25 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ropinirole HCl 0.25 mg tablet | Generic | $0.046 per tablet | $1.38 | -3% |
| Ropinirole HCl 0.5 mg tablet | Generic | $0.043 per tablet | $1.29 | -5% |
| Ropinirole HCl 1 mg tablet | Generic | $0.0477 per tablet | $1.43 | -8% |
| Ropinirole HCl 2 mg tablet | Generic | $0.0672 per tablet | $2.02 | -3% |
| Ropinirole HCl 3 mg tablet | Generic | $0.0768 per tablet | $2.30 | -4% |
| Ropinirole HCl 4 mg tablet | Generic | $0.0814 per tablet | $2.44 | +4% |
| Ropinirole HCl 5 mg tablet | Generic | $0.0843 per tablet | $2.53 | -5% |
| Ropinirole HCl ER 12 mg tablet | Generic | $1.81 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $54.33 | -22% |
| Ropinirole HCl ER 2 mg tablet | Generic | $0.349 per tablet | $10.46 | -26% |
| Ropinirole HCl ER 4 mg tablet | Generic | $0.462 per tablet | $13.85 | -45% |
| Ropinirole HCl ER 6 mg tablet | Generic | $1.34 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $40.23 | +22% |
| Ropinirole HCl ER 8 mg tablet | Generic | $0.907 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $27.20 | -35% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ropinirole been recalled?
The FDA's Enforcement Report lists 13 recalls naming ropinirole since 2013: 0 Class I (the most serious), 13 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 20, 2023 | Class II | RemedyRepack Inc. | cGMP Deviations |
| March 13, 2023 | Class II | Direct Rx | cGMP deviations |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| October 9, 2013 | Class II | Sandoz, Inc | Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of … |
| April 22, 2013 | Class II | Mylan Pharmaceuticals Inc. | Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets.. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ropinirole label say about other medicines?
The ropinirole label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name ropinirole. 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 |
|---|---|---|
| Amantadine | drug interactions | Commonly Administered Drugs: Population analysis showed that commonly administered drugs (e.g., selegiline, amantadine, tricyclic antidepressants, benzodiazepines, ibuprofen, thiazides, antihistamines, anticholinergics) did not affect the clearance of ropinirole. |
| Carbidopa | drug interactions | Coadministration of carbidopa + L-dopa (10/100 mg twice daily) with ropinirole (2 mg 3 times daily) had no effect on the steady-state pharmacokinetics of ropinirole (n = 28 patients). |
| Ciprofloxacin | drug interactions | Coadministration of ciprofloxacin, an inhibitor of CYP1A2, increases the AUC and C max of ropinirole [ see Clinical Pharmacology ( 12.3 ) ]. |
| Digoxin | drug interactions | Drug Interaction Studies Digoxin: Coadministration of ropinirole (2 mg 3 times daily) with digoxin (0.125 to 0.25 mg once daily) did not alter the steady-state pharmacokinetics of digoxin in 10 patients. |
| Ibuprofen | drug interactions | Commonly Administered Drugs: Population analysis showed that commonly administered drugs (e.g., selegiline, amantadine, tricyclic antidepressants, benzodiazepines, ibuprofen, thiazides, antihistamines, anticholinergics) did not affect the clearance of ropinirole. |
| Levodopa | warnings and precautions | In controlled clinical trials in patients with Parkinson’s disease, syncope was observed more frequently in patients receiving ropinirole than in patients receiving placebo (early Parkinson’s disease without levodopa [L-dopa]: ropinirole 12%, placebo 1%; advanced Parkinson’s disease: ropinirole 3%, placebo 2%). |
| Metoclopramide | drug interactions | Dopamine antagonists (e.g., neuroleptics, metoclopramide): May reduce efficacy of ropinirole. |
| Selegiline | drug interactions | Commonly Administered Drugs: Population analysis showed that commonly administered drugs (e.g., selegiline, amantadine, tricyclic antidepressants, benzodiazepines, ibuprofen, thiazides, antihistamines, anticholinergics) did not affect the clearance of ropinirole. |
| Theophylline | drug interactions | Theophylline: Administration of theophylline (300 mg twice daily), a substrate of CYP1A2, did not alter the steady-state pharmacokinetics of ropinirole (2 mg 3 times daily) in 12 patients with Parkinson’s disease. |
Source: FDA drug label (ropinirole), Glenmark Pharmaceuticals Inc., USA, effective January 16, 2026 (SPL set 85971b31-6f7d-421c-bf3c-5b33f3c1e781), via openFDA; the full label on DailyMed
What do FAERS reports show for ropinirole?
The FDA Adverse Event Reporting System holds 18,695 reports that list ropinirole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,662 are coded as a death and 5,588 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 ropinirole?
13 other medicines are given the same way (oral) and in the same FDA class as ropinirole 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 |
|---|---|---|---|---|
| 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 |
| Carbidopa and entacapone and levodopa | Parkinson's disease | 4 labelers | $0.695 per tablet 25-100-200 mg tablet | No current entry |
| Trihexyphenidyl | Parkinson's disease | 8 labelers | $0.0884 per tablet 2 mg tablet | No current entry |
| Entacapone | Parkinson's disease | 11 labelers | $0.325 per tablet 200 mg tablet | No current entry |
| Selegiline | Parkinson's disease | 11 labelers | $0.756 per capsule 5 mg capsule | No current entry |
Every medicine labeled for the same conditions as ropinirole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ropinirole compare with medicines for the same use?
1 side-by-side page set ropinirole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ropinirole
- 13 medicines for the same use
- Other nonergot dopamine agonists
- the pharmacologic class, with prices and generics
- Ropinirole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other