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Causality: well established
Causality assessment · Causality: well established
Haloperidol and Tardive dyskinesia: 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.
Haloperidol ↔ Tardive dyskinesia
n=378 co-reports · PRR 11.7 · ROR 11.8
Haloperidol, as a high-potency typical antipsychotic, carries a substantial risk of tardive dyskinesia with prolonged use; 378 co-reports give PRR 11.7. The label warns of this potentially irreversible effect and advises the lowest effective dose and periodic assessment.
Regulatory basis: haloperidol prescribing information — tardive dyskinesia warning; lowest effective dose.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Months to years of use |
| Strength | met | PRR 11.7 with 378 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to antipsychotics |
| Biological gradient | met | Cumulative dose-related |
| Plausibility | met | Known dopaminergic supersensitivity |
| Coherence | met | Fits haloperidol's chronic effect |
| Experiment | n/a | Chronic and under-coded in trials |
| Analogy | met | Analogous to other antipsychotic tardive syndromes |
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 haloperidol captured tardive dyskinesia as a tracked adverse event in a usable structure. Tardive effects appear after chronic exposure and are rarely captured in time-limited trials.