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Causality: well established
Causality assessment · Causality: well established
Haloperidol and Prolonged QT interval: 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 ↔ Prolonged QT interval
n=653 co-reports · PRR 16.0 · ROR 16.4
Haloperidol prolongs the QT interval and can cause torsades de pointes, particularly with intravenous or high-dose use and co-administered QT-prolonging drugs; 653 co-reports give PRR 16.0. The label warns of this risk and advises ECG monitoring in at-risk patients.
Regulatory basis: haloperidol prescribing information — QT prolongation/torsades de pointes warning.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Hours after dosing |
| Strength | met | PRR 16.0 with 653 co-reports |
| Consistency | met | Consistent across reports |
| Specificity | not established | QT prolongation has many causes |
| Biological gradient | met | Dose/route-related |
| Plausibility | met | Known hERG blockade |
| Coherence | met | Fits haloperidol's cardiac effect |
| Experiment | n/a | Monitored in some trials |
| Analogy | met | Analogous to other antipsychotic QT effects |
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 prolonged qt interval as a tracked adverse event in a usable structure. QT effect is recognised but confounded by co-medication and the underlying agitation being treated.