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Causality: well established
Causality assessment · Causality: well established
Rivaroxaban and Gastrointestinal Haemorrhage: 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.
Rivaroxaban ↔ Gastrointestinal Haemorrhage
n=21,636 co-reports · PRR 34.9 · ROR 38.9
Allopurinol is a xanthine oxidase inhibitor for hyperuricemia and chronic gout. The co-reporting of gout as a reaction is a coding artifact: patients on allopurinol for gout have the indication recorded as the AE. 1,682 co-reports (PRR 21.8) reflect the treated population.
Coding artifact: gout is the indication.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | not established | Indication artifact |
| Strength | not established | PRR reflects treated population |
| Consistency | not established | Not reproduced |
| Specificity | not established | Not specific |
| Biological gradient | not established | No gradient |
| Plausibility | not established | No mechanism |
| Coherence | not established | Artifact |
| Experiment | not established | Not an endpoint |
| Analogy | not established | N/A |
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 Rivaroxaban captured gastrointestinal haemorrhage as a tracked adverse event in a usable structure. Gout is the indication; trials do not track it as an AE.