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Causality: well established
Causality assessment · Causality: well established
Alosetron Hydrochloride and Constipation: 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.
Alosetron Hydrochloride ↔ Constipation
n=128 co-reports · PRR 14.9 · ROR 17.4
Rufinamide is a triazole anticonvulsant for Lennox-Gastaut syndrome. Suicidal ideation carries a label warning. 106 co-reports (PRR 121.0) are a strong signal but in a very small treated population. The label carries a boxed warning for SJS/TEN and suicidal ideation.
Boxed warning: rufinamide label (SJS/TEN, suicidal ideation). FDA PI.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 121.0 with 106 co-reports |
| Consistency | not established | Not reproduced across anticonvulsant class |
| Specificity | partial | Known from other anticonvulsants |
| Biological gradient | not established | No consistent gradient |
| Plausibility | not established | Unknown mechanism |
| Coherence | partial | CNS effect plausible |
| Experiment | n/a | Not an RCT endpoint |
| Analogy | not established | Not applicable to all anticonvulsants |
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 Alosetron captured constipation as a tracked adverse event in a usable structure. Suicidal ideation is a rare AE; anticonvulsant RCTs are not powered for this endpoint.