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Causality: well established
Causality assessment · Causality: well established
Rivaroxaban and Gastrointestinal bleeding: 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 bleeding
n=21,636 co-reports · PRR 34.9 · ROR 38.9
Rivaroxaban is a direct factor Xa inhibitor, so bleeding is the expected hazard of its intended anticoagulant effect, and its gastrointestinal bleeding rate is at least as high as warfarin's in the major randomized trials. The high FAERS count (21,636 co-reports, PRR 34.9) reflects the drug's very large real-world population and the severity that drives reporting. As with all anticoagulants, the signal is a pharmacodynamic extension of the mechanism rather than an off-target surprise.
Regulatory basis: rivaroxaban prescribing information (bleeding warning); ROCKET-AF randomized trial.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Bleeding occurs during anticoagulation and typically stops after the drug is withdrawn |
| Strength | met | PRR 35 on one of the largest co-report counts on this page |
| Consistency | met | Reproduced in randomized outcome trials and in real-world cohorts |
| Specificity | partial | An anticoagulant-class effect rather than rivaroxaban-specific |
| Biological gradient | partial | Risk rises with dose, renal impairment, age, and interacting drugs |
| Plausibility | met | Factor Xa inhibition impairs haemostasis — bleeding is the pharmacodynamic extension |
| Coherence | met | Coheres with the bleeding-focused labelling and monitoring |
| Experiment | met | Randomized evidence (ROCKET-AF) and cohort studies directly quantify the risk |
| Analogy | met | Analogous to bleeding with warfarin, apixaban, and dabigatran |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ The results-posting rivaroxaban trial that surfaced (NCT02504216) recorded serious bleeding terms only in the rivaroxaban arm, but in very small numbers; the bleeding excess is quantified by the large randomized outcome trial ROCKET-AF and real-world cohorts, not by one trial AE table.