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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Mirtazapine 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.
Mirtazapine ↔ Suicidal Ideation
n=2,410 co-reports · PRR 6.2 · ROR 6.3
Etonogestrel is a progestin-only contraceptive implant. The co-reporting of pregnancy as a reaction is a paradoxical artifact: while the drug prevents pregnancy, breakthrough pregnancy can occur (typical-use failure rate ~0.05 %). 1,985 co-reports (PRR 17.3) reflect the large implant-user population and stimulated reporting.
Coding/paradox artifact: breakthrough pregnancy is a contraceptive failure mode.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | not established | Paradoxical artifact |
| Strength | not established | PRR reflects large population |
| Consistency | not established | Breakthrough pregnancy is not pharmacologically caused |
| Specificity | not established | Not specific |
| Biological gradient | not established | No gradient |
| Plausibility | not established | No mechanism for causing pregnancy |
| Coherence | not established | Does not cohere with mechanism |
| Experiment | n/a | Not an RCT endpoint |
| Analogy | not established | Not applicable |
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 Mirtazapine captured suicidal ideation as a tracked adverse event in a usable structure. Contraceptive failure is tracked in efficacy studies, not as a drug-caused AE.