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Causality: well established
Causality assessment · Causality: well established
Risperidone 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.
Risperidone ↔ Neuroleptic malignant syndrome
n=2,246 co-reports · PRR 36.8 · ROR 37.4
Risperidone, like other antipsychotics, can cause neuroleptic malignant syndrome, a life-threatening hyperthermic rigid syndrome; 2,246 co-reports give PRR 36.8. The label warns of the reaction and requires immediate withdrawal if it occurs.
Regulatory basis: risperidone prescribing information — neuroleptic malignant syndrome warning.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Days after start or change |
| Strength | met | PRR 36.8 with 2,246 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to antipsychotics |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Known dopaminergic blockade |
| Coherence | met | Fits risperidone's D2 antagonism |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to haloperidol 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.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for risperidone captured neuroleptic malignant syndrome as a tracked adverse event in a usable structure. A rare idiosyncratic emergency is not detectable in randomised psychiatric trials.