← All causality assessments
Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Olanzapine and Diabetes mellitus: 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.
Olanzapine ↔ Diabetes mellitus
n=5,404 co-reports · PRR 14.8 · ROR 15.6
Olanzapine is associated with hyperglycaemia and new-onset diabetes, sometimes without preceding weight gain; 5,404 co-reports give PRR 14.8. The label advises baseline and periodic glucose monitoring and warns of severe hyperglycaemia.
Regulatory basis: olanzapine prescribing information — hyperglycaemia/diabetes warning; glucose monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Weeks to months |
| Strength | met | PRR 14.8 with 5,404 co-reports |
| Consistency | met | Consistent across cohorts |
| Specificity | not established | Diabetes is common generally |
| Biological gradient | met | Duration-related |
| Plausibility | met | Plausible insulin-resistance mechanism |
| Coherence | met | Fits olanzapine's metabolic profile |
| Experiment | n/a | Monitored in trials |
| Analogy | met | Analogous to clozapine dysglycaemia |
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 olanzapine captured diabetes mellitus as a tracked adverse event in a usable structure. Metabolic monitoring is recommended, but background diabetes prevalence confounds signal interpretation.