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Causality: well established
Causality assessment · Causality: well established
Ropinirole (dopamine agonists) and Impulse-control disorder: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Ropinirole (dopamine agonists) ↔ Impulse-control disorder
n=92 co-reports · PRR 64.2 · ROR 64.6
Like pramipexole, ropinirole can cause impulse-control disorders — pathological gambling, compulsive shopping or eating, and hypersexuality — through over-stimulation of dopamine reward pathways. The behaviours are genuine, can arise at therapeutic doses, and usually improve when the drug is withdrawn or reduced; the class carries explicit labelling. The very high PRR (64.2) again reflects how tightly this term maps to dopamine agonists.
Regulatory basis: ropinirole prescribing information (impulse-control disorders); EMA/FDA dopamine-agonist class reviews (2010s).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Behaviours emerge during treatment and often resolve after dose reduction or withdrawal |
| Strength | met | Very high PRR, characteristic of dopamine agonists |
| Consistency | met | Reproduced across the class and in cohort studies |
| Specificity | met | A distinctive dopamine-agonist effect, uncommon with other drugs |
| Biological gradient | met | Broadly dose-related |
| Plausibility | met | Dopamine-receptor over-stimulation of reward pathways is the mechanism |
| Coherence | met | Coheres with the class labelling and patient warnings |
| Experiment | partial | Dechallenge (dose reduction/withdrawal) usually reverses it; no randomized trial |
| Analogy | met | Analogous to impulse-control disorders with pramipexole and other dopamine agonists |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for ropinirole captured impulse-control disorder as a coded event; it is identified through clinical interview and case series rather than a trial AE table.