What the label lists and what reports show
Ropinirole side effects
Ropinirole's FDA label: “Most common adverse reactions (incidence with ropinirole 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.” FAERS holds 18,695 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fall (1,253 reports).
- Generic listed
Check it at the source: the ropinirole FDA label on DailyMed (effective January 16, 2026, Glenmark Pharmaceuticals Inc., USA); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ropinirole tablets?Ropinirole tablets can cause serious side effects, including: • See “What is the most important information I should know about ropinirole tablets?” The most common side effects of ropinirole tablets include: • fainting • sleepiness or drowsiness • hallucinations (seeing or hearing things that are not real) • dizziness • nausea or vomiting • uncontrolled sudden movements • upset stomach, abdominal pain or discomfort • fatigue, tiredness, or weakness • confusion • headache • leg swelling • increased sweating • constipation • suddenly falling asleep • high blood pressure (hypertension) Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects with ropinirole tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions (incidence with ropinirole 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.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Body System/Adverse Reaction | Ropinirole (n = 157) (%) | Placebo (n = 147) (%) |
|---|---|---|
| Flushing | 3 | 1 |
| Dry mouth | 5 | 3 |
| Increased sweating | 6 | 4 |
| Asthenic condition b | 16 | 5 |
| Chest pain | 4 | 2 |
| Dependent edema | 6 | 3 |
| Leg edema | 7 | 1 |
| Pain | 8 | 4 |
| Hypertension | 5 | 3 |
| Hypotension | 2 | 0 |
| Orthostatic symptoms | 6 | 5 |
| Syncope | 12 | 1 |
| Dizziness | 40 | 22 |
| Hyperkinesia | 2 | 1 |
| Hypesthesia | 4 | 2 |
| Vertigo | 2 | 0 |
| Abdominal pain | 6 | 3 |
| Anorexia | 4 | 1 |
| Dyspepsia | 10 | 5 |
| Flatulence | 3 | 1 |
| Nausea | 60 | 22 |
| Vomiting | 12 | 7 |
| Extrasystoles | 2 | 1 |
| Atrial fibrillation | 2 | 0 |
| Palpitation | 3 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described in more detail in other sections of the label: • Hypersensitivity [ see Contraindications ( 4 ) ] • Falling asleep during activities of daily living and somnolence [ see Warnings and Precautions ( 5.1 ) ] • Syncope [ see Warnings and Precautions ( 5.2 ) ] • Hypotension/orthostatic hypotension [ see Warnings and Precautions ( 5.3 ) ] • Hallucinations/psychotic-like behavior [ see Warnings and Precautions ( 5.4 ) ] • Dyskinesia [ see Warnings and Precautions ( 5.5 ) ] • Impulse control/compulsive behaviors [ see Warnings and Precautions ( 5.6 ) ] • Withdrawal-emergent hyperpyrexia and confusion [ see Warnings and Precautions ( 5.7 ) ] • Withdrawal Symptoms [ see Warnings and Precautions ( 5.8) ] • Augmentation and early-morning rebound in RLS [ see Warnings and Precautions ( 5.9) ] • Fibrotic complications [ see Warnings and Precautions ( 5.10 ) ] • Retinal pathology [ see Warnings and Precautions ( 5.11 ) ] Most common adverse reactions (incidence with ropinirole 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. ( 6.1 ) • Advanced PD: Dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, sweating, and headache. …
Source: FDA drug label, 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?
18,695 reports list ropinirole among the medicines taken, 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. Of the 20 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ropinirole: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions