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Causality: well established
Causality assessment · Causality: well established
Haloperidol and Neuroleptic malignant syndrome: 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 ↔ Neuroleptic malignant syndrome
n=1,630 co-reports · PRR 138.0 · ROR 147.9
Haloperidol is a leading cause of neuroleptic malignant syndrome, a life-threatening reaction of hyperthermia, rigidity and autonomic instability that can occur after any exposure; 1,630 co-reports give an extreme PRR of 138.0. Prompt recognition and withdrawal are essential.
Regulatory basis: haloperidol prescribing information — neuroleptic malignant syndrome warning.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Days after start or dose change |
| Strength | met | PRR 138.0, an extreme signal |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to antipsychotics |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Known dopaminergic blockade mechanism |
| Coherence | met | Fits haloperidol's D2 antagonism |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to other antipsychotic NMS |
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 — The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study (NCT01211522)
| Adverse event | Haloperidol (n=192) · Ziprasidone (n=190) · Placebo (n=184) | ||
|---|---|---|---|
| Neuroleptic malignant syndrome | 0/192 | 0/190 | 0/184 |
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 →