← All causality assessments
Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Vortioxetine 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.
Vortioxetine ↔ Suicidal Ideation
n=942 co-reports · PRR 12.9 · ROR 13.6
Tramadol is a weak mu-opioid agonist with SNRI properties for pain. Drug abuse is the expected consequence of mu-opioid activity. 2,179 co-reports (PRR 10.9) reflect moderate abuse liability. The label carries a boxed warning for abuse, dependence, and misuse.
Boxed warning: tramadol label (abuse/dependence/misuse). DEA Schedule IV.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 10.9 with 2,179 co-reports |
| Consistency | met | Reproduced across opioid class |
| Specificity | partial | Specific to mu-opioid agonists |
| Biological gradient | met | Tolerance documented |
| Plausibility | met | Known mechanism |
| Coherence | met | Withdrawal recognised |
| Experiment | n/a | Not an RCT endpoint |
| Analogy | met | Other opioids show dependence |
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 Vortioxetine captured suicidal ideation as a tracked adverse event in a usable structure. Pain RCTs are short-term; abuse liability assessed in separate studies.