← All causality assessments
Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Pramipexole and Hypersexuality: 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.
Pramipexole ↔ Hypersexuality
n=115 co-reports · PRR 92.0 · ROR 92.7
Pramipexole is a dopamine agonist whose stimulation of mesolimbic D3 receptors produces prominent impulse-control disorders — pathological gambling, hypersexuality, compulsive shopping and eating — with 115 hypersexuality co-reports here (PRR 92.0). These behaviours are a recognised class effect that the FDA required to be added to labelling, and they often improve on dose reduction or withdrawal.
Regulatory basis: pramipexole prescribing information — impulse-control disorders class warning; dopamine-agonist literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Emerges after weeks to months |
| Strength | met | PRR 92.0, an extreme signal |
| Consistency | met | Reproduced across dopamine agonists |
| Specificity | partial | Shared across the class |
| Biological gradient | met | Dose-related |
| Plausibility | met | Mesolimbic D3-receptor stimulation |
| Coherence | met | Fits the pharmacology |
| Experiment | met | Reported in trials and registries |
| Analogy | met | Analogous to ropinirole impulse-control disorders |
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.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for pramipexole captured hypersexuality as a tracked adverse event in a usable structure. Parkinson's-disease trials rarely captured compulsive behaviours as structured coded adverse events.