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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Haloperidol and Hyperprolactinaemia: 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 ↔ Hyperprolactinaemia
n=255 co-reports · PRR 35.4 · ROR 35.8
Haloperidol blocks pituitary dopamine D2 receptors, releasing prolactin from tonic inhibition and producing hyperprolactinaemia; 255 co-reports give PRR 35.4. The effect is dose-related and can cause galactorrhoea, gynaecomastia and sexual dysfunction, and typical antipsychotics raise prolactin more than atypicals.
Regulatory basis: haloperidol prescribing information — hyperprolactinaemia and endocrine effects.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Within days to weeks |
| Strength | met | PRR 35.4 with 255 co-reports |
| Consistency | met | Consistent across studies |
| Specificity | not established | Prolactin varies in the population |
| Biological gradient | met | Clear dose relation |
| Plausibility | met | Known D2-blockade mechanism |
| Coherence | met | Fits haloperidol's endocrine effect |
| Experiment | n/a | Measurable but not a routine endpoint |
| Analogy | met | Analogous to risperidone hyperprolactinaemia |
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 hyperprolactinaemia as a tracked adverse event in a usable structure. Prolactin is not routinely measured or coded as an adverse event in psychiatric trials.