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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Venlafaxine Hydrochloride and Suicidal Ideation: 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.
Venlafaxine Hydrochloride ↔ Suicidal Ideation
n=4,167 co-reports · PRR 7.5 · ROR 7.8
Mirtazapine is a tetracyclic antidepressant. Weight increased is expected from its potent H1 receptor antagonism, a well-recognised pharmacological effect of this class. 413 co-reports (PRR 19.1) reflect a common and dose-dependent metabolic effect. The label includes warnings about weight gain.
Label: mirtazapine PI (weight gain). J. Clinical Psychiatry 2017, PMID: 28822351.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 19.1 with 413 co-reports |
| Consistency | met | Reproduced across H1-antagonist class |
| Specificity | not established | Not specific |
| Biological gradient | met | Correlates with dose |
| Plausibility | met | Known H1 blockade mechanism |
| Coherence | met | Coherent with pharmacology |
| Experiment | met | RCTs confirm |
| Analogy | met | Other tetracyclics similar |
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 Venlafaxine captured suicidal ideation as a tracked adverse event in a usable structure. Weight gain is a standard metabolic AE endpoint in antidepressant registration trials.