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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Fluoxetine 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.
Fluoxetine Hydrochloride ↔ Suicidal Ideation
n=3,701 co-reports · PRR 6.9 · ROR 7.1
Tacrolimus is a calcineurin inhibitor immunosuppressant used post-transplant. Incision site complication is not a pharmacologically plausible effect of tacrolimus; these are complications of the surgical transplant procedure itself. 4,770 co-reports (PRR 8.4) reflect the post-surgical population.
Coding artifact: post-surgical complication.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | not established | Surgical confound |
| Strength | not established | Not a drug effect |
| Consistency | not established | Not reproduced in non-surgical populations |
| Specificity | not established | No specificity |
| Biological gradient | not established | No gradient |
| Plausibility | not established | No mechanism |
| Coherence | not established | Coherent only as surgical artifact |
| Experiment | not established | Not an 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 Fluoxetine captured suicidal ideation as a tracked adverse event in a usable structure. Incision site complications are surgical risks, not drug-related AEs.