Drug · FAERS side-effect profile with label screen
Ropinirole Hydrochloride side effects: what 3,543 FDA adverse event reports show
Drug class
Nonergot Dopamine Agonist
FDA label (Established Pharmacologic Class)
Who reports
3,543 reports · 60% serious · 216 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
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 )
FDA label, Indications and Usage
What it is
Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 4Labeled (related wording) 3Reporting / coding artifact 4Lab value / disease marker 2Not in label — unassessed 27
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.
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 226 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Full blood count abnormal | 70 | 39.5 31.3–49.9ROR 40.3 · χ² 2,575 / p <1e-300 | 38.9 EB05 31.8 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious PRR 49.7 · ♀ 100% (drug 68%) | no trial data cached |
| Restless legs syndrome | 87 | 28.4 23.1–35.0ROR 29.1 · χ² 2,264 / p <1e-300 | 28.1 EB05 23.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 28.7 | no trial data cached |
| Type 2 diabetes mellitus | 99 | 17.4 14.3–21.1ROR 17.9 · χ² 1,511 / p <1e-300 | 17.3 EB05 14.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · ♀ 96% (drug 68%) | no trial data cached |
| Hyperglycaemia (high blood sugar) | 92 | 15.0 12.3–18.4ROR 15.4 · χ² 1,189 / p 7e-261 | 14.9 EB05 12.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · ♀ 99% (drug 68%) | no trial data cached |
| Delusion | 39 | 14.9 10.9–20.4ROR 15.1 · χ² 492 / p 2e-109 | 14.7 EB05 11.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.1 · 70% consumer | no trial data cached |
| Hallucination, visual | 52 | 14.7 11.2–19.3ROR 14.9 · χ² 649 / p 2e-143 | 14.5 EB05 11.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Hallucination (hallucinations) | 144 | 11.4 9.7–13.4ROR 11.8 · χ² 1,356 / p 4e-297 | 11.3 EB05 9.8 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 · ♀ 42% (drug 68%) | no trial data cached |
| Muscle rigidity | 22 | 10.9 7.2–16.6ROR 11.0 · χ² 188 / p 4e-43 | 10.0 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Dyskinesia (involuntary movements) | 71 | 10.4 8.2–13.1ROR 10.6 · χ² 592 / p 4e-131 | 10.1 EB05 8.2 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 139 | 10.3 8.7–12.1ROR 10.7 · χ² 1,157 / p 9e-254 | 10.1 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 · ♀ 94% (drug 68%) | no trial data cached |
| Haemorrhoids | 33 | 10.0 7.1–14.1ROR 10.1 · χ² 258 / p 2e-58 | 9.4 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · ♀ 97% (drug 68%) | no trial data cached |
| Initial insomnia | 17 | 9.9 6.1–15.9ROR 9.9 · χ² 127 / p 1e-29 | 8.6 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Blood count abnormal | 24 | 9.2 6.2–13.8ROR 9.3 · χ² 168 / p 9e-39 | 8.4 EB05 5.7 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 12.5 · ♀ 96% (drug 68%) | no trial data cached |
| Seasonal allergy | 22 | 9.2 6.1–14.0ROR 9.3 · χ² 153 / p 2e-35 | 8.3 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=13 · 73% consumer | no trial data cached |
| Infusion site pain | 19 | 8.8 5.6–13.8ROR 8.9 · χ² 124 / p 5e-29 | 7.7 EB05 5.1 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Asthma | 151 | 8.0 6.8–9.3ROR 8.3 · χ² 919 / p 5e-202 | 7.8 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · ♀ 96% (drug 68%) | no trial data cached |
| Spinal operation | 16 | 7.8 4.8–12.8ROR 7.9 · χ² 89 / p 3e-21 | 6.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 | no trial data cached |
| Skin laceration | 14 | 7.7 4.6–13.0ROR 7.7 · χ² 75 / p 3e-18 | 6.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Paranoia | 20 | 6.8 4.4–10.6ROR 6.9 · χ² 94 / p 2e-22 | 6.0 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Hypersomnia | 31 | 6.4 4.5–9.1ROR 6.5 · χ² 136 / p 9e-32 | 5.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Skin lesion | 27 | 5.9 4.0–8.6ROR 5.9 · χ² 104 / p 8e-25 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 100% (drug 68%) | no trial data cached |
| Sleep disorder due to a general medical condition | 16 | 5.9 3.6–9.6ROR 5.9 · χ² 60 / p 6e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Tooth abscess | 10 | 5.8 3.1–10.8ROR 5.8 · χ² 35 / p 2e-9 | 4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Intentional dose omission | 26 | 5.6 3.8–8.3ROR 5.7 · χ² 94 / p 1e-22 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 · 77% consumer | no trial data cached |
| Incontinence | 10 | 5.6 3.0–10.4ROR 5.6 · χ² 33 / p 4e-9 | 4.5 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Impaired gastric emptying | 12 | 5.6 3.2–9.8ROR 5.6 · χ² 41 / p 1e-10 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Middle insomnia | 17 | 5.4 3.4–8.7ROR 5.4 · χ² 57 / p 2e-14 | 4.8 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Hallucination, auditory | 14 | 5.2 3.1–8.8ROR 5.2 · χ² 43 / p 2e-11 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Balance disorder | 76 | 5.2 4.2–6.5ROR 5.3 · χ² 254 / p 2e-57 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 74% consumer | no trial data cached |
| Limb injury | 23 | 5.0 3.3–7.6ROR 5.1 · χ² 70 / p 3e-17 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 76% consumer | no trial data cached |
| Sleep apnoea syndrome | 16 | 5.0 3.0–8.1ROR 5.0 · χ² 47 / p 4e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Nasal congestion (stuffy nose) | 48 | 4.9 3.7–6.4ROR 4.9 · χ² 143 / p 2e-33 | 4.6 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 14 | 4.7 2.8–8.0ROR 4.8 · χ² 38 / p 4e-10 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Thinking abnormal | 15 | 4.7 2.9–7.9ROR 4.8 · χ² 41 / p 9e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 | no trial data cached |
| Device occlusion | 11 | 4.7 2.6–8.4ROR 4.7 · χ² 28 / p 5e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Dementia | 22 | 4.7 3.1–7.1ROR 4.7 · χ² 60 / p 5e-15 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 43% (drug 68%) | no trial data cached |
| Eye pain | 43 | 4.6 3.4–6.2ROR 4.7 · χ² 118 / p 8e-28 | 4.4 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.2 · 88% consumer | no trial data cached |
| Hiatus hernia | 10 | 4.6 2.5–8.5ROR 4.6 · χ² 24 / p 4e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Joint injury | 16 | 4.4 2.7–7.2ROR 4.4 · χ² 39 / p 2e-10 | 4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Poor quality sleep | 16 | 4.4 2.7–7.2ROR 4.4 · χ² 39 / p 2e-10 | 4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Fall | 213 | 3.8 3.3–4.3ROR 4.0 · χ² 442 / p 2e-98 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Product dose omission issue | 156 | 3.2 2.8–3.8ROR 3.3 · χ² 243 / p 4e-55 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 · 71% consumer | no trial data cached |
| Asthma | 151 | 8.0 6.8–9.3ROR 8.3 · χ² 919 / p 5e-202 | 7.8 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · ♀ 96% (drug 68%) | no trial data cached |
| Hallucination (hallucinations) | 144 | 11.4 9.7–13.4ROR 11.8 · χ² 1,356 / p 4e-297 | 11.3 EB05 9.8 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 · ♀ 42% (drug 68%) | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 139 | 10.3 8.7–12.1ROR 10.7 · χ² 1,157 / p 9e-254 | 10.1 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 · ♀ 94% (drug 68%) | no trial data cached |
| Insomnia (trouble sleeping) | 131 | 2.9 2.5–3.4ROR 3.0 · χ² 164 / p 8e-38 | 2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 · 71% consumer | no trial data cached |
| Depression | 117 | 3.0 2.5–3.6ROR 3.1 · χ² 159 / p 1e-36 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Somnolence (drowsiness) | 114 | 3.4 2.8–4.0ROR 3.4 · χ² 188 / p 4e-43 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Urinary tract infection (bladder infection) | 103 | 3.6 3.0–4.3ROR 3.7 · χ² 191 / p 1e-43 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Gait disturbance | 101 | 3.1 2.6–3.8ROR 3.2 · χ² 144 / p 2e-33 | 3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Type 2 diabetes mellitus | 99 | 17.4 14.3–21.1ROR 17.9 · χ² 1,511 / p <1e-300 | 17.3 EB05 14.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · ♀ 96% (drug 68%) | no trial data cached |
| Tremor (shaking) | 94 | 3.3 2.7–4.1ROR 3.4 · χ² 153 / p 2e-35 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 92 | 15.0 12.3–18.4ROR 15.4 · χ² 1,189 / p 7e-261 | 14.9 EB05 12.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · ♀ 99% (drug 68%) | no trial data cached |
| Feeling abnormal | 91 | 2.2 1.8–2.7ROR 2.3 · χ² 62 / p 2e-15 | 2.2 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.9 · 74% consumer | no trial data cached |
| Restless legs syndrome | 87 | 28.4 23.1–35.0ROR 29.1 · χ² 2,264 / p <1e-300 | 28.1 EB05 23.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 28.7 | no trial data cached |
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 legs syndrome — n=87, PRR 28.4
- Type 2 diabetes mellitus — n=99, PRR 17.4
- Hyperglycaemia — n=92, PRR 15.0
- Hallucination, visual — n=52, PRR 14.7
- Muscle rigidity — n=22, PRR 10.9
- Gastrooesophageal reflux disease — n=139, PRR 10.3
- Haemorrhoids — n=33, PRR 10.0
- Seasonal allergy — n=22, PRR 9.2
- Asthma — n=151, PRR 8.0
- Paranoia — n=20, PRR 6.8
✓ 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, asthma, hallucination, gastrooesophageal reflux disease, insomnia, depression. 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, 266 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
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.