Ropinirole and Hallucination: is the FAERS signal real?
Ropinirole ↔ Hallucination
Ropinirole is a dopamine agonist for Parkinson's disease and restless legs; hallucinations and impulse-control disorders are class effects of dopamine agonists, and hallucinations carry 747 co-reports here (PRR 13.8). The risk rises with age, dose, and co-treatment with levodopa, and the label advises dose reduction or withdrawal if they occur.
Regulatory basis: ropinirole prescribing information — hallucinations and impulse-control disorders; dopamine-agonist class warning.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Hallucinations emerge after months |
| Strength | met | PRR 13.8, large |
| Consistency | met | Reproduced across dopamine agonists |
| Specificity | partial | Shared across the class |
| Biological gradient | met | Dose-related |
| Plausibility | met | Excess dopaminergic stimulation |
| Coherence | met | Fits the pharmacology |
| Experiment | met | Trials and registries support it |
| Analogy | met | Analogous to pramipexole hallucinations |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✓ Trial evidence found — A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients (NCT01628926)
| Adverse event | SPM 962 (n=168) · Ropinirole (n=167) · Placebo (n=85) | ||
|---|---|---|---|
| Hallucination Visual | 13/168 | 10/167 | 3/85 |
| Hallucination | 3/168 | 6/167 | 0/85 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →