Ropinirole
Ropinirole is a dopamine agonist used to treat Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome (RLS).
🧬 Where this information comes from
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 61 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Ropinirole (Requip) is a long-established dopamine agonist, meaning it mimics dopamine in the brain. It is used for Parkinson's disease (early on or alongside levodopa) and, as the immediate-release tablet, for moderate-to-severe restless legs syndrome, and it is available as a generic. Most people do fine once the dose is raised slowly, though nausea, drowsiness and lightheadedness on standing (a blood pressure drop) are common at first. Watch for falling asleep suddenly during daily activities, even driving, sometimes with no warning sleepiness, and for new compulsive urges like gambling, overeating or sexual behavior. Never stop it abruptly, since that can trigger high fever and confusion.
Clinical pearls
- For restless legs, take it 1 to 3 hours before bedtime; extended-release Requip XL is approved only for Parkinson's.
- Swallow Requip XL whole, never chewed, crushed or split.
- Starting or quitting smoking, or starting or stopping estrogen hormone therapy, can shift ropinirole levels enough to need a dose change.
- Ciprofloxacin and fluvoxamine can raise ropinirole levels, while metoclopramide and antipsychotics like haloperidol can blunt its effect.
Patient Information Guide A plain-language walkthrough of Ropinirole, written from its FDA label.
What Ropinirole Is Used For
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Ropinirole is used across two main conditions, depending on the formulation:
- Parkinson's disease: Both ropinirole tablets and ropinirole extended-release tablets are approved to treat the signs and symptoms of Parkinson's disease, including in patients on and off concurrent levodopa (L-dopa) therapy.
- Moderate-to-severe primary Restless Legs Syndrome (RLS): Ropinirole tablets (immediate-release) are approved for RLS — the uncomfortable urge to move the legs that is worse at rest and in the evening. Ropinirole extended-release tablets are not indicated for RLS.
How Ropinirole Works
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Ropinirole is a dopamine agonist — it mimics the effects of dopamine, a natural chemical messenger in the brain. In Parkinson's disease, the brain gradually loses the cells that make dopamine, disrupting movement signals. Ropinirole steps in by directly activating dopamine D2 receptors (docking sites on brain cells), particularly in a region called the caudate-putamen, helping restore more normal movement control. For RLS, the mechanism is less clear, but stimulating dopamine receptors is also thought to ease the uncomfortable sensations in the legs.
Ropinirole Dosage
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Ropinirole is always started at a low dose and increased gradually over weeks to find the right level for each person. Both the tablet and extended-release tablet can be taken with or without food. Ropinirole tablets for Parkinson's disease are taken three times daily; for RLS, the tablet is taken once daily, 1 to 3 hours before bedtime. Ropinirole extended-release tablets are taken once daily and must be swallowed whole — never chewed, crushed, or split. If you miss several doses or therapy is interrupted, your prescriber may need to retitrate (restart at a lower dose and work back up). Never stop ropinirole suddenly — it should always be tapered gradually, especially for Parkinson's disease.
Dosing details from the FDA-approved label
From the Ropinirole prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Parkinson's disease (ropinirole extended-release tablets)
- Starting dose 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at weekly or longer intervals, based on therapeutic response and tolerability
- Taken once daily, with or without food
- Tablets must be swallowed whole and not chewed, crushed, or divided
- Maximum: 24 mg/day (patients with advanced Parkinson's disease should generally be maintained at 8 mg or lower, and patients with early Parkinson's disease at 12 mg or lower)
- Discontinue gradually over a 7-day period; retitration may be warranted if therapy is interrupted
- Parkinson's disease, switching from immediate-release ropinirole tablets to extended-release tablets
- Initial dose of extended-release tablets should approximately match the total daily dose of immediate-release ropinirole (e.g., 0.75 to 2.25 mg to 2 mg
- 3 to 4.5 mg to 4 mg
- 6 mg to 6 mg
- 7.5 to 9 mg to 8 mg
- 12 mg to 12 mg
- 15 mg to 16 mg
- 18 mg to 18 mg
- 21 mg to 20 mg
- 24 mg to 24 mg)
- Dose may be adjusted afterward depending on therapeutic response and tolerability
- Parkinson's disease with end-stage renal disease on hemodialysis (extended-release tablets)
- Initial dose 2 mg once daily
- Further dose escalations based on tolerability and need for efficacy
- Maximum: 18 mg/day
- No adjustment for moderate renal impairment (creatinine clearance 30 to 50 mL/min); supplemental doses after dialysis not required
- Parkinson's disease (ropinirole immediate-release tablets)
- Starting dose 0.25 mg 3 times daily
- Week 1 0.25 mg 3 times daily (0.75 mg total), Week 2 0.5 mg 3 times daily (1.5 mg), Week 3 0.75 mg 3 times daily (2.25 mg), Week 4 1 mg 3 times daily (3 mg)
- After Week 4, may increase by 1.5 mg/day weekly up to 9 mg/day, then by up to 3 mg/day weekly
- Maximum: 24 mg/day (8 mg 3 times daily)
- Can be taken with or without food; discontinue over 7 days: twice daily for 4 days, then once daily for the remaining 3 days
- Parkinson's disease with end-stage renal disease on hemodialysis (immediate-release tablets)
- Initial dose 0.25 mg 3 times a day
- Further dose escalations based on tolerability and need for efficacy
- Maximum: 18 mg/day
- No adjustment for moderate renal impairment (creatinine clearance 30 to 50 mL/min); supplemental doses after dialysis not required
- Restless legs syndrome (immediate-release tablets)
- Starting dose 0.25 mg once daily 1 to 3 hours before bedtime
- After 2 days, if necessary, 0.5 mg once daily, and 1 mg once daily at the end of the first week
- Then Week 2 1 mg, Week 3 1.5 mg, Week 4 2 mg, Week 5 2.5 mg, Week 6 3 mg, Week 7 4 mg
- Maximum: 4 mg daily
- Gradual reduction of the daily dose recommended when discontinuing
- Restless legs syndrome with end-stage renal disease on hemodialysis
- Initial dose 0.25 mg once daily
- Further dose escalations based on tolerability and need for efficacy
- Maximum: 3 mg/day
- No adjustment for moderate renal impairment (creatinine clearance 30 to 50 mL/min); supplemental doses after dialysis not required
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Ropinirole extended-release tablets are taken once daily, with or without food; tablets must be swallowed whole and not be chewed, crushed, or divided. ( 2.1 ) • The recommended starting dose is 2 mg taken once daily for 1 to 2 weeks; the dose should be increased by 2 mg/day at 1 week or longer intervals. The maximum recommended dose of ropinirole extended-release tablets is 24 mg/day. ( 2.2 , 14.2 ) • Renal Impairment: In patients with end-stage renal disease on hemodialysis, the maximum recommended dose is 18 mg/day. ( 2.2 ) • If ropinirole extended-release tablets must be discontinued, it should be tapered gradually over a 7-day period; retitration of ropinirole extended-release tablets may be warranted if therapy is interrupted. ( 2.1 , 2.2 ) • Patients may be switched directly from immediate-release ropinirole to ropinirole extended-release tablets; the initial switching dose of ropinirole extended-release tablets should approximately match the total daily dose of immediate-release ropinirole. ( 2.3 ) 2.1 General Dosing Recommendations • Ropinirole extended-release tablets are taken once daily, with or without food [see Clinical Pharmacology ( 12.3 )] . • Tablets must be swallowed whole and must not be chewed, crushed, or divided. • If a significant interruption in therapy with ropinirole extended-release tablets has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s Disease The recommended starting dose of ropinirole extended-release tablets is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at weekly or longer intervals, based on therapeutic response and tolerability. Monitor patients at least weekly during dose titration. Too rapid a rate of titration may lead to the selection of a dose that does not provide additional benefit, but increases the risk of adverse reactions. In fixed-dose studies designed to characterize the dose response to ropinirole extended-release tablets, there was no additional therapeutic benefit shown in patients with advanced stage Parkinson’s disease taking daily doses greater than 8 mg/day, or with early stage Parkinson’s disease taking doses greater than 12 mg/day [see Clinical Studies ( 14.1 and 14.2 )] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Ropinirole Side Effects
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The most common side effects include:
Common side effects
- Nausea
- Dizziness or lightheadedness
- Drowsiness or sudden sleepiness
- Headache
- Constipation
- Dyskinesia (uncontrolled, involuntary movements)
- Hallucinations (seeing or hearing things that aren't there)
- Abdominal pain or discomfort
When to get medical help
- Call your doctor if you fall asleep suddenly during daily activities like driving — this can happen without warning
- Seek immediate help if you faint or pass out (syncope)
- Tell your doctor about dizziness when standing up, which may signal a dangerous drop in blood pressure (orthostatic hypotension)
- Report any new or unusual compulsive behaviors — gambling, excessive eating, or increased sexual urges
- Get help right away for hallucinations, confusion, or other psychotic-like symptoms
- Tell your doctor if you develop uncontrolled muscle movements (dyskinesia)
- Seek emergency care if you develop high fever, confusion, or muscle rigidity after stopping the medication
More serious reactions — including sudden sleep attacks, severe blood pressure drops, impulse-control problems, and psychotic-like behavior — require immediate medical attention. Contact your doctor right away if you experience any of these.
Ropinirole Warnings and Precautions
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- Sudden sleep attacks: Ropinirole can cause you to fall asleep abruptly during daily activities, including driving, sometimes with no warning drowsiness. Avoid driving or operating machinery until you know how this drug affects you.
- Low blood pressure on standing (orthostatic hypotension): You may feel dizzy or faint when getting up quickly, especially early in treatment or during dose increases. Rise slowly from sitting or lying down.
- Hallucinations and psychotic-like behavior: Some people experience seeing or hearing things that aren't there. Older adults are at higher risk. Tell your doctor immediately.
- Impulse-control problems: Ropinirole can trigger compulsive behaviors such as gambling, overeating, or increased sexual urges. These may not feel out of character to you, so let family members know to watch for changes.
- Dyskinesia: Uncontrolled movements may appear or worsen, especially in patients also taking L-dopa.
- Do not stop suddenly: Abruptly stopping ropinirole — particularly in Parkinson's disease — can cause a serious reaction called withdrawal-emergent hyperpyrexia (a dangerous rise in body temperature with confusion). Always taper under your doctor's guidance.
Ropinirole Interactions
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Ropinirole is broken down by a liver enzyme called CYP1A2, so drugs or habits that affect this enzyme can significantly change how much ropinirole stays in your system:
- CYP1A2 inhibitors (ciprofloxacin, fluvoxamine, norfloxacin, mexiletine): Block the enzyme that clears ropinirole, raising its blood levels — dose reduction may be needed.
- Smoking: Activates CYP1A2 and speeds up ropinirole clearance; quitting or starting smoking can meaningfully change your drug levels.
- Hormone replacement therapy (estrogens): Can slow ropinirole clearance; starting or stopping HRT may require a dose adjustment.
- Dopamine antagonists (metoclopramide, antipsychotics like phenothiazines or haloperidol): Work against ropinirole's mechanism and may reduce its effectiveness.
Interactions listed in the FDA-approved label
From the Ropinirole prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- CYP1A2 inhibitors and inducers (e.g., ciprofloxacin): May alter the clearance of ropinirole; ciprofloxacin, an inhibitor of CYP1A2, increases the AUC and Cmax of ropinirole with immediate-release ropinirole. If a potent CYP1A2 inducer or inhibitor is stopped or started during treatment, adjustment of the ropinirole dose may be required.
- Cigarette smoking: Expected to increase the clearance of ropinirole since CYP1A2 is induced by smoking.
- Estrogens / hormone replacement therapy (HRT): Higher doses of estrogens reduced the clearance of ropinirole. Starting or stopping hormone replacement therapy may require adjustment of the ropinirole dose.
- Dopamine antagonists (e.g., neuroleptics such as phenothiazines, butyrophenones, thioxanthenes; metoclopramide): May reduce the efficacy of ropinirole because ropinirole is a dopamine agonist.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Inhibitors or inducers of CYP1A2: May alter the clearance of ropinirole; dose adjustment of ropinirole extended-release tablets may be required. ( 7.1 , 12.3 ) • Hormone replacement therapy (HRT): Starting or stopping HRT treatment may require dose adjustment of ropinirole extended-release tablets. ( 7.2 , 12.3 ) • Dopamine antagonists (e.g., neuroleptics metoclopramide): May reduce efficacy of ropinirole extended-release tablets. ( 7.3 ) 7.1 Cytochrome P450 1A2 Inhibitors and Inducers In vitro metabolism studies showed that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of ropinirole. There is thus the potential for inducers or inhibitors of this enzyme to alter the clearance of ropinirole. Therefore, if therapy with a drug known to be a potent inducer or inhibitor of CYP1A2 is stopped or started during treatment with ropinirole extended-release tablets, adjustment of the dose of ropinirole extended-release tablets may be required. Coadministration of ciprofloxacin, an inhibitor of CYP1A2, with immediate-release ropinirole increases the AUC and C max of ropinirole [see Clinical Pharmacology ( 12.3 )] . Cigarette smoking is expected to increase the clearance of ropinirole since CYP1A2 is known to be induced by smoking [see Clinical Pharmacology ( 12.3 )] . 7.2 Estrogens Population pharmacokinetic analysis revealed that higher doses of estrogens (usually associated with hormone replacement therapy) reduced the clearance of ropinirole. Starting or stopping hormone replacement therapy may require adjustment of dosage of ropinirole extended-release tablets [see Clinical Pharmacology ( 12.3 )] . 7.3 Dopamine Antagonists Because ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes) or metoclopramide may reduce the efficacy of ropinirole extended-release tablets.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before Taking Ropinirole
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- Allergy: Do not take ropinirole if you have ever had an allergic reaction (hives, swelling, rash, itching) to it or any of its ingredients — this is a contraindication.
- Pregnancy: Animal studies showed potential harm to developing fetuses. There are no adequate human studies. Discuss the risks and benefits with your doctor if you are pregnant or planning to become pregnant.
- Breastfeeding: Ropinirole is expected to suppress milk production (it lowers prolactin). Discuss with your doctor before breastfeeding.
- Children: Safety and effectiveness in children have not been established.
- Older adults (65+): The drug clears slightly more slowly in older adults, and hallucinations are significantly more common in this group. Doses are still individually adjusted to response.
- Kidney disease: Moderate kidney impairment generally does not require a dose change, but patients on dialysis (end-stage renal disease) require a lower maximum dose.
- Smokers: Smoking speeds the clearance of ropinirole; quitting may increase drug levels and require a dose adjustment.
Ropinirole Overdose
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Taking too much ropinirole can cause symptoms related to excessive dopamine activity, including nausea, dizziness, hallucinations, vomiting, fainting, excessive sweating, uncontrolled movements, agitation, chest pain, and extreme drowsiness. If you suspect an overdose, seek emergency medical help immediately. General supportive care — maintaining vital signs and monitoring — is the main approach.
What Ropinirole Does in the Body
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Ropinirole activates dopamine receptors in the brain, and this can affect blood pressure regulation — particularly causing a drop in blood pressure when you stand up (orthostatic hypotension), especially when the dose is being increased. In some cases, this has been associated with slowing of the heart rate (bradycardia) or, rarely, brief episodes of loss of consciousness. Ropinirole also suppresses prolactin (a hormone involved in milk production) even at low doses, which means it may inhibit lactation in breastfeeding individuals.
How Your Body Processes Ropinirole
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After you take a ropinirole immediate-release tablet, it is absorbed quickly, reaching peak levels in the blood in about 1 to 2 hours; food does not change how much is absorbed overall. The extended-release tablet reaches peak levels more slowly (roughly 6 to 10 hours) and a high-fat meal can modestly increase the total amount absorbed. Ropinirole is processed extensively by the liver — primarily by an enzyme called CYP1A2 — and most of it leaves the body through the urine as inactive breakdown products within about 6 hours (its half-life). Because smokers have more active CYP1A2, they clear the drug about 30–38% faster than non-smokers.
How to Store Ropinirole
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Store at room temperature between 20°C and 25°C (68°F and 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Protect from light and moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & Herbs That Interact With Ropinirole
101 supplements and herbal products have documented interactions with Ropinirole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 67
- Minor · 33
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Ropinirole: Pharmacist Answers to Common Questions
Quick, plain-English answers to the questions patients ask most about Ropinirole — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is ropinirole used for?
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I heard ropinirole can make you fall asleep suddenly — is that really true?
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Can I stop taking ropinirole if I don't like how it makes me feel?
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Are there any medications or habits I should tell my doctor about before starting this?
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What side effects should I just watch for versus which ones need a call to the doctor?
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Is ropinirole safe to take during pregnancy or while breastfeeding?
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Is Ropinirole available over the counter?
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When was Ropinirole first available?
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Who makes Ropinirole?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More About Ropinirole on HelloPharmacist
Ropinirole Forms and Strengths (How It Comes)
Ropinirole is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Ropinirole inactive ingredients by manufacturer.
Tablet
How this form is used
- Used to treat Parkinson's disease
- Used to treat moderate-to-severe primary Restless Legs Syndrome (RLS)
- Ropinirole tablets can be taken with or without food
- For Parkinson's disease, tablets are typically taken three times daily
- For RLS, tablets are taken once daily, 1 to 3 hours before bedtime
- If therapy is interrupted, retitration (restarting at a low dose and working back up) may be needed
Show 1 more strength Show fewer strengths
Extended-release tablet
How this form is used
- Ropinirole extended-release tablets are used to treat Parkinson's disease
- Ropinirole extended-release tablets are taken once daily, with or without food
- Tablets must be swallowed whole — do not chew, crush, or divide them
- If extended-release therapy is interrupted, retitration may be needed
- If extended-release tablets must be stopped, they should be tapered gradually over a 7-day period
Ropinirole on the U.S. Market: Products, Makers and Brands
How Ropinirole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
25 companies list 149 Ropinirole product records with the FDA, mostly as tablet, extended-release tablet; the earliest marketing or approval year on record is 1997. Brand names on the directory include Requip, Requip XL; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How Widely Ropinirole Is Used (Medicaid Data)
A general measure of how commonly Ropinirole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ropinirole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ropinirole prescribed? Of the 1,603 medications we measure, Ropinirole ranks #236 by Medicaid prescriptions — more than 85% of them.
Utilization by Ropinirole product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
ropinirole 1 MG Oral Tablet Most dispensed
Summed across the 6 of 70 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314208
ropinirole 0.5 MG Oral Tablet
Summed across the 5 of 63 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312846
ropinirole 0.25 MG Oral Tablet
Summed across the 6 of 58 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312845
ropinirole 2 MG Oral Tablet
Summed across the 5 of 40 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312847
ropinirole 3 MG Oral Tablet
Summed across the 4 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 283858
ropinirole 4 MG Oral Tablet
Summed across the 4 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 562704
ropinirole 5 MG Oral Tablet
Summed across the 4 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312849
24 HR ropinirole 2 MG Extended Release Oral Tablet
Summed across the 4 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 799055
24 HR ropinirole 4 MG Extended Release Oral Tablet
Summed across the 4 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 799056
24 HR ropinirole 6 MG Extended Release Oral Tablet
Summed across the 3 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 848582
24 HR ropinirole 8 MG Extended Release Oral Tablet
Summed across the 4 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 799054
24 HR ropinirole 12 MG Extended Release Oral Tablet
Summed across the 1 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 824959
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ropinirole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 50 of 424 listed Ropinirole NDCs with Medicaid activity.
Compare Ropinirole Products
A representative set of FDA-listed product records for Ropinirole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Extended-release tablet | ||||
| 2 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 4 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 6 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 8 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 12 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 2 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 4 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 6 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 8 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 12 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 2 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 4 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 6 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 8 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 12 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 2 mg | Oral | AvKARE | ANDA | View NDC → |
| 4 mg | Oral | AvKARE | ANDA | View NDC → |
| 6 mg | Oral | AvKARE | ANDA | View NDC → |
| 8 mg | Oral | AvKARE | ANDA | View NDC → |
| 12 mg | Oral | AvKARE | ANDA | View NDC → |
| 2 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 4 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 6 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 8 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 12 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 2 mg | Oral | Dr. Reddys Laboratories Limited | ANDA | View NDC → |
| 4 mg | Oral | Dr. Reddys Laboratories Limited | ANDA | View NDC → |
| 6 mg | Oral | Dr. Reddys Laboratories Limited | ANDA | View NDC → |
| 8 mg | Oral | Dr. Reddys Laboratories Limited | ANDA | View NDC → |
| 12 mg | Oral | Dr. Reddys Laboratories Limited | ANDA | View NDC → |
| 2 mg | Oral | Elite Laboratories, Inc. | ANDA | View NDC → |
| 4 mg | Oral | Elite Laboratories, Inc. | ANDA | View NDC → |
| 6 mg | Oral | Elite Laboratories, Inc. | ANDA | View NDC → |
| 8 mg | Oral | Elite Laboratories, Inc. | ANDA | View NDC → |
| 12 mg | Oral | Elite Laboratories, Inc. | ANDA | View NDC → |
| 2 mg | Oral | Solco Healthcare US, LLC | ANDA | View NDC → |
| 4 mg | Oral | Solco Healthcare US, LLC | ANDA | View NDC → |
| 6 mg | Oral | Solco Healthcare US, LLC | ANDA | View NDC → |
| 8 mg | Oral | Solco Healthcare US, LLC | ANDA | View NDC → |
| 12 mg | Oral | Solco Healthcare US, LLC | ANDA | View NDC → |
| 💊Tablet | ||||
| 0.25 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 1 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 4 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 0.25 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 0.5 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 1 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 2 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 3 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 4 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 5 mg | Oral | Accord Healthcare Inc. | ANDA | View NDC → |
| 0.25 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 0.5 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 1 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 2 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 3 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 4 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 5 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 0.25 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 0.5 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 1 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 2 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 3 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 4 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 5 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 0.25 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 1 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 0.25 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 0.5 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 1 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 2 mg | Oral | Asclemed Usa Inc. | ANDA | View NDC → |
| 0.25 mg | Oral | AvPAK | ANDA | View NDC → |
| 0.5 mg | Oral | AvPAK | ANDA | View NDC → |
| 1 mg | Oral | AvPAK | ANDA | View NDC → |
| 2 mg | Oral | AvPAK | ANDA | View NDC → |
| 0.25 mg | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 0.5 mg | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 1 mg | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 2 mg | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 3 mg | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 4 mg | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 5 mg | Oral | Bionpharma Inc. | ANDA | View NDC → |
| 0.25 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 0.5 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 1 mg | Oral | Bryant Ranch Prepack × 5 listings | ANDA | View NDC → |
| 2 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 0.25 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 1 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 2 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 3 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 1 mg | Oral | Direct Rx | ANDA | View NDC → |
| 0.25 mg | Oral | Direct_Rx × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 0.25 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 0.5 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 1 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 2 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 3 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 4 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 5 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 0.25 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 1 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 0.25 mg | Oral | Marlex Pharmaceuticals Inc | ANDA | View NDC → |
| 0.5 mg | Oral | Marlex Pharmaceuticals Inc | ANDA | View NDC → |
| 1 mg | Oral | Marlex Pharmaceuticals Inc | ANDA | View NDC → |
| 2 mg | Oral | Marlex Pharmaceuticals Inc | ANDA | View NDC → |
| 3 mg | Oral | Marlex Pharmaceuticals Inc | ANDA | View NDC → |
| 4 mg | Oral | Marlex Pharmaceuticals Inc | ANDA | View NDC → |
| 5 mg | Oral | Marlex Pharmaceuticals Inc | ANDA | View NDC → |
| 0.25 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 0.5 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 1 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 2 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 0.25 mg | Oral | Northwind Health Company, LLC | ANDA | View NDC → |
| 2 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 0.25 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 0.5 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 2 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 0.25 mg | Oral | Solco Healthcare Us, Llc × 2 listings | ANDA | View NDC → |
| 0.5 mg | Oral | Solco Healthcare Us, Llc × 2 listings | ANDA | View NDC → |
| 1 mg | Oral | Solco Healthcare Us, Llc × 2 listings | ANDA | View NDC → |
| 2 mg | Oral | Solco Healthcare Us, Llc × 2 listings | ANDA | View NDC → |
| 3 mg | Oral | Solco Healthcare Us, Llc × 2 listings | ANDA | View NDC → |
| 4 mg | Oral | Solco Healthcare Us, Llc × 2 listings | ANDA | View NDC → |
| 5 mg | Oral | Solco Healthcare Us, Llc × 2 listings | ANDA | View NDC → |
Showing 149 of 149 products — FDA National Drug Code Directory. See every product, package size and price: browse all 149 Ropinirole NDCs →
Ropinirole Side Effects Reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ropinirole — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ropinirole in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Ropinirole FDA Approval History
How Ropinirole went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Ropinirole Recall History
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Ropinirole recall since July 2021, covering 7 product listings. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, N… Lots: Batches: P2104150, P2104151, Exp. Date 6/30/2023, P2202065, Exp. Date 3/31/2024 FDA record D-0431-2023 →
- rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, N… Lots: Batches: P2106136, Exp. Date 8/31/2023, P2106813, P2106814, Exp. Date 9/30/2023, P2202764, Exp. Date 4/30/2024 FDA record D-0430-2023 →
- rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA,… Lots: Batches: P2105099, P2105098, Exp. Date 7/31/2023, P2106507, P2106508, P2106510, P2106509, Exp. Date 9/30/2023, P2202750, Exp. Date 4/30/2024 FDA record D-0429-2023 →
- rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA.… Lots: Batches: P2106370, P2106369, Exp. Date 9/30/2023, P2201254, Exp. Date 2/29/2024 FDA record D-0428-2023 →
- rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA,… Lots: Batches: P2103544 Exp. Date 5/31/2023, P2106132, P2106131, P2106128, P2106129, P2106130, P2106133, Exp. Date 8/31/2023, P2107662, P2107663, P2107664, Exp. Date 11/30/2023, P2203543, Exp. Date 5/31/2024 FDA record D-0427-2023 →
- rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA… Lots: Batches: P2102133, P2102135, P2102136, Exp. Date 3/31/2023, P2104998, P2104997, P2104991, P2104992, P2104990, P2104993, P2105000, P2104999, P2105002, P2105001, Exp. Date 7/31/2023, P2106812, Exp. Date, 9/30/2023, P2200433, P2200434, P22004… FDA record D-0426-2023 →
- rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDI… Lots: Batches: P2102086, Exp. Date 3/31/2023; P2105094, P2105095, P2105097, P2105096, P2105093, Exp. Date 7/31/2023; P2106490, P2106491, P2106493, P2106492, P2106494, Exp. Date 9/30/2023; P2201069, P2201068, P2201067, Exp. Date 1/31/2024; P22035… FDA record D-0425-2023 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 72302 2 dose forms · 12 strengths
-
Dose form (SCDF) Extended Release Oral Tablet RxCUI 799053In current FDA listingsClinical drug / strength (SCD) 24 HR ropinirole 12 MGRxCUI 82495924 HR ropinirole 2 MGRxCUI 79905524 HR ropinirole 4 MGRxCUI 79905624 HR ropinirole 6 MGRxCUI 84858224 HR ropinirole 8 MGRxCUI 799054 -
Dose form (SCDF) Oral Tablet RxCUI 373800In current FDA listings
Look up RxCUI 72302 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Ropinirole Supply and Shortage Status
Whether Ropinirole is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Ropinirole Costs Pharmacies (NADAC Benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated, Extended Release · Oral | 12 mg | $1.81 per tablet | NDC details & price history |
| Tablet, Film Coated, Extended Release · Oral | 8 mg | $0.907 per tablet | NDC details & price history |
| Tablet, Film Coated, Extended Release · Oral | 4 mg | $0.462 per tablet | NDC details & price history |
| Tablet, Film Coated, Extended Release · Oral | 2 mg | $0.349 per tablet | NDC details & price history |
| Tablet, Film Coated, Extended Release · Oral | 6 mg | $1.34 per tablet | NDC details & price history |
| Tablet, Extended Release · Oral | 6 mg | $1.34 per tablet | NDC details & price history |
| Tablet, Extended Release · Oral | 4 mg | $0.462 per tablet | NDC details & price history |
| Tablet, Extended Release · Oral | 2 mg | $0.349 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Ropinirole Brand Names
Ropinirole is sold under 2 brand names in the FDA directory — Requip, Requip XL. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who Makes Ropinirole: Manufacturers and Labelers
25 companies list Ropinirole products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Solco Healthcare Us, Llc, Alembic Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 1 more on the FDA NDC directory.
Ropinirole Drug Class (RxNorm)
Ropinirole belongs to the Nonergot Dopamine Agonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for This Ropinirole Page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Solco Healthcare US, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →