Ropinirole side effects: what 15,252 FDA adverse event reports show
Drug class
Nonergot Dopamine Agonist
Who reports
15,252 reports · 65% serious · 1,452 with death outcome · 62% female
Used for
Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease. Ropinirole extended-release tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease. ( 1 )
What it is
Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,084 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Restless leg augmentation syndrome | 27 | 335.7 220.3–511.4ROR 336.3 · χ² 6,955 / p <1e-300 | 226.3 EB05 163.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=26 · 81% consumer | not reported in cached trials |
| Dopamine dysregulation syndrome | 71 | 259.3 201.3–334.1ROR 260.6 · χ² 15,121 / p <1e-300 | 205.8 EB05 168.7 · IC025 +6.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=69 · 100% clinician | not reported in cached trials |
| Parkinsonism hyperpyrexia syndrome | 18 | 151.5 93.1–246.5ROR 151.7 · χ² 2,287 / p <1e-300 | 119.4 EB05 79.9 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=18 | not reported in cached trials |
| Jealous delusion | 24 | 126.6 83.3–192.2ROR 126.8 · χ² 2,620 / p <1e-300 | 106.3 EB05 75.1 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 29% (drug 62%) · 100% clinician | not reported in cached trials |
| Stoma site reaction | 41 | 88.5 64.5–121.3ROR 88.7 · χ² 3,247 / p <1e-300 | 80.1 EB05 61.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=40 | not reported in cached trials |
| Stoma site odour | 12 | 77.4 43.3–138.5ROR 77.5 · χ² 786 / p 4e-173 | 66.0 EB05 40.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Stoma site erythema | 95 | 73.5 59.8–90.3ROR 74.0 · χ² 6,378 / p <1e-300 | 68.9 EB05 58.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=89 | not reported in cached trials |
| Hypersexuality | 87 | 68.4 55.2–84.8ROR 68.8 · χ² 5,436 / p <1e-300 | 64.3 EB05 53.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=84 · ♀ 15% (drug 62%) | not reported in cached trials |
| Dropped head syndrome | 18 | 66.6 41.5–107.0ROR 66.7 · χ² 1,048 / p 4e-230 | 59.7 EB05 40.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Freezing phenomenon | 166 | 66.5 56.9–77.6ROR 67.2 · χ² 10,145 / p <1e-300 | 63.0 EB05 55.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=138 · ♀ 34% (drug 62%) | not reported in cached trials |
| On and off phenomenon | 243 | 66.5 58.5–75.5ROR 67.5 · χ² 14,879 / p <1e-300 | 63.1 EB05 56.7 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=223 | not reported in cached trials |
| Stoma site discharge | 126 | 66.2 55.4–79.1ROR 66.7 · χ² 7,651 / p <1e-300 | 62.6 EB05 53.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=118 | not reported in cached trials |
| Impulse-control disorder | 92 | 64.2 52.1–79.1ROR 64.6 · χ² 5,408 / p <1e-300 | 60.6 EB05 50.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=86 · ♀ 41% (drug 62%) | not reported in cached trials |
| Stoma site irritation | 24 | 63.0 41.9–94.9ROR 63.1 · χ² 1,341 / p 6e-294 | 57.7 EB05 40.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Parkinsonian gait | 25 | 57.5 38.6–85.8ROR 57.6 · χ² 1,278 / p 3e-280 | 53.1 EB05 37.8 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=25 | not reported in cached trials |
| Stoma site pain | 58 | 56.7 43.6–73.7ROR 56.9 · χ² 2,994 / p <1e-300 | 53.6 EB05 43.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=53 | not reported in cached trials |
| Fibroma | 35 | 53.8 38.4–75.4ROR 53.9 · χ² 1,693 / p <1e-300 | 50.4 EB05 37.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=35 | not reported in cached trials |
| Gambling | 43 | 52.0 38.4–70.5ROR 52.1 · χ² 2,022 / p <1e-300 | 49.1 EB05 38.0 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=34 | not reported in cached trials |
| Rapid eye movement sleep behaviour disorder | 14 | 49.9 29.3–85.1ROR 50.0 · χ² 601 / p 5e-133 | 45.4 EB05 28.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Deep brain stimulation | 20 | 48.9 31.3–76.4ROR 49.0 · χ² 860 / p 2e-189 | 45.4 EB05 31.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Sleep attacks | 16 | 48.0 29.1–79.0ROR 48.0 · χ² 666 / p 4e-147 | 44.1 EB05 28.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Compulsions | 22 | 47.9 31.3–73.2ROR 47.9 · χ² 930 / p 1e-204 | 44.6 EB05 31.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 35% (drug 62%) | not reported in cached trials |
| Compulsive shopping | 69 | 47.4 37.3–60.2ROR 47.6 · χ² 2,982 / p <1e-300 | 45.3 EB05 37.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=67 | not reported in cached trials |
| Reduced facial expression | 32 | 45.3 31.9–64.4ROR 45.4 · χ² 1,299 / p 8e-285 | 42.8 EB05 31.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=31 | not reported in cached trials |
| Euthanasia | 10 | 44.7 23.8–84.0ROR 44.8 · χ² 373 / p 3e-83 | 40.3 EB05 23.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Stereotypy | 29 | 43.9 30.3–63.5ROR 43.9 · χ² 1,135 / p 3e-249 | 41.4 EB05 30.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 32% (drug 62%) · 100% clinician | not reported in cached trials |
| Hyperkinesia | 63 | 42.7 33.2–54.8ROR 42.8 · χ² 2,445 / p <1e-300 | 40.9 EB05 33.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=62 · ♀ 42% (drug 62%) | not reported in cached trials |
| Periodic limb movement disorder | 11 | 42.2 23.2–76.9ROR 42.3 · χ² 390 / p 4e-87 | 38.5 EB05 22.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Stoma site hypergranulation | 17 | 38.0 23.4–61.4ROR 38.0 · χ² 560 / p 5e-124 | 35.6 EB05 23.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Stoma site infection | 34 | 37.1 26.4–52.1ROR 37.2 · χ² 1,128 / p 2e-247 | 35.5 EB05 26.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=34 · 74% consumer | not reported in cached trials |
| Stoma site inflammation | 19 | 36.0 22.8–56.8ROR 36.1 · χ² 596 / p 5e-132 | 34.0 EB05 23.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Sexually inappropriate behaviour | 11 | 33.7 18.5–61.2ROR 33.7 · χ² 309 / p 2e-69 | 31.2 EB05 18.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 23 | 30.0 19.9–45.3ROR 30.0 · χ² 603 / p 2e-133 | 28.8 EB05 20.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Pathological gambling | 35 | 29.2 20.9–40.8ROR 29.2 · χ² 905 / p 4e-199 | 28.2 EB05 21.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 26% (drug 62%) | not reported in cached trials |
| Gambling disorder | 56 | 28.9 22.2–37.7ROR 29.0 · χ² 1,451 / p <1e-300 | 28.1 EB05 22.4 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=51 | not reported in cached trials |
| Bradykinesia | 114 | 27.4 22.8–32.9ROR 27.6 · χ² 2,816 / p <1e-300 | 26.8 EB05 22.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=110 | not reported in cached trials |
| Stoma complication | 19 | 26.1 16.6–41.0ROR 26.1 · χ² 425 / p 1e-94 | 25.0 EB05 16.9 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=17 | not reported in cached trials |
| Restless legs syndrome | 337 | 25.9 23.3–28.8ROR 26.5 · χ² 7,900 / p <1e-300 | 25.4 EB05 23.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 26.1 | not reported in cached trials |
| Occipital neuralgia | 10 | 24.9 13.3–46.5ROR 24.9 · χ² 202 / p 4e-46 | 23.2 EB05 13.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Device loosening | 15 | 24.8 14.9–41.2ROR 24.8 · χ² 313 / p 3e-70 | 23.6 EB05 15.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=14 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ropinirole as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT01628926 — A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients (N=420, PHASE3; 35 AE terms posted; arms: SPM 962; Ropinirole; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,192 | 1.2 1.2–1.3ROR 1.3 · χ² 61 / p 3e-15 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.4 | not reported in cached trials |
| Fall | 1,049 | 4.3 4.1–4.6ROR 4.6 · χ² 2,735 / p <1e-300 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | not reported in cached trials |
| Fatigue (tiredness) | 952 | 1.7 1.6–1.8ROR 1.7 · χ² 274 / p 7e-62 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | not reported in cached trials |
| Nausea | 900 | 1.6 1.5–1.7ROR 1.6 · χ² 192 / p 6e-44 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT01628926: 23/167 (13.8%) on Ropinirole; 7/85 (8.2%) control |
| Dizziness | 750 | 2.1 1.9–2.2ROR 2.1 · χ² 424 / p 1e-94 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | not reported in cached trials |
| Hallucination (hallucinations) | 747 | 13.8 12.9–14.8ROR 14.5 · χ² 8,816 / p <1e-300 | 13.7 EB05 12.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.4 · ♀ 41% (drug 62%) | NCT01628926: 10/167 (6.0%) on Ropinirole; 3/85 (3.5%) control |
| Death | 659 | 1.1 1.0–1.1ROR 1.1 · χ² 2 / p 0.097 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.9 | not reported in cached trials |
| Pain | 648 | 1.4 1.3–1.6ROR 1.5 · χ² 92 / p 4e-22 | 1.4 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT01628926: 5/167 (3.0%) on Ropinirole; 2/85 (2.4%) control |
| Diarrhoea (diarrhea) | 628 | 1.3 1.2–1.4ROR 1.4 · χ² 56 / p 3e-14 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.2 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 610 | 1.5 1.4–1.6ROR 1.5 · χ² 98 / p 2e-23 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.4 | not reported in cached trials |
| Asthenia (weakness) | 591 | 2.2 2.0–2.3ROR 2.2 · χ² 374 / p 1e-83 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | not reported in cached trials |
| Off label use (used outside approved label) | 578 | 0.9 0.8–1.0ROR 0.9 · χ² 5 / p 0.016 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Headache | 546 | 1.2 1.1–1.3ROR 1.2 · χ² 18 / p 9e-6 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.4 | not reported in cached trials |
| Insomnia (trouble sleeping) | 543 | 2.8 2.6–3.0ROR 2.9 · χ² 634 / p 4e-140 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | not reported in cached trials |
| Gait disturbance | 527 | 3.8 3.5–4.1ROR 3.9 · χ² 1,082 / p 1e-237 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Restless leg augmentation syndrome — n=27, PRR 335.7
- Jealous delusion — n=24, PRR 126.6
- Stoma site reaction — n=41, PRR 88.5
- Stoma site erythema — n=95, PRR 73.5
- Hypersexuality — n=87, PRR 68.4
- Freezing phenomenon — n=166, PRR 66.5
- On and off phenomenon — n=243, PRR 66.5
- Stoma site discharge — n=126, PRR 66.2
- Impulse-control disorder — n=92, PRR 64.2
- Stoma site irritation — n=24, PRR 63.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Ropinirole (dopamine agonists) ↔ Impulse-control disorder.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ropinirole?
In FDA FAERS, the most frequently co-reported reaction terms for Ropinirole are fall, fatigue, nausea, dizziness, hallucination, pain. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ropinirole have an FDA boxed warning?
No. The FDA label retrieved for Ropinirole has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ropinirole causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 213dd2f4-4a71-456c-b3c7-b709c7bd7445, effective 20250523; matched on
openfda.generic_name.exact:"ROPINIROLE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,124 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
ROPINIROLE, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.