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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Levodopa and Hallucination: 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.
Levodopa ↔ Hallucination
n=656 co-reports · PRR 15.4 · ROR 16.2
Levodopa commonly causes visual hallucinations and other dopaminergic psychiatric effects, especially in older patients and with higher doses; 656 co-reports give PRR 15.4. The label lists hallucinations and advises dose adjustment and caution.
Regulatory basis: levodopa/carbidopa prescribing information — hallucinations; dose adjustment guidance.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Weeks to months |
| Strength | met | PRR 15.4 with 656 co-reports |
| Consistency | met | Consistent across cohorts |
| Specificity | not established | Psychosis occurs in Parkinson's disease |
| Biological gradient | met | Dose-related |
| Plausibility | met | Known dopaminergic mechanism |
| Coherence | met | Fits levodopa's CNS effects |
| Experiment | n/a | Often coded in trials |
| Analogy | met | Analogous to dopamine-agonist 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 | 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 →