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Causality: well established
Causality assessment · Causality: well established
Ibuprofen (NSAIDs) 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.
Ibuprofen (NSAIDs) ↔ Gastrointestinal bleeding
n=2,645 co-reports · PRR 2.5 · ROR 2.5
Ibuprofen and other non-steroidal anti-inflammatory drugs cause gastrointestinal bleeding by blocking the COX-1 enzyme that protects the stomach lining, and this is a genuine class effect whose risk rises with dose, age, and co-therapy with steroids, anticoagulants, or other NSAIDs. It is the reason NSAIDs carry prominent gastrointestinal warnings. The 2,645 co-reports (PRR 2.5) — a modest disproportionality on a huge co-report count — reflect how extremely widely ibuprofen is used.
Regulatory basis: ibuprofen/NSAID prescribing information (gastrointestinal bleeding and ulcer warnings). Established NSAID-gastrotoxicity literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Bleeding occurs during NSAID use and stops after withdrawal |
| Strength | partial | PRR 2.5 with a very large co-report count — common but not highly disproportionate |
| Consistency | met | Reproduced across NSAIDs and in trials |
| Specificity | met | A class effect shared across non-selective NSAIDs |
| Biological gradient | partial | Dose-related and worse with age and interacting drugs |
| Plausibility | met | COX-1 inhibition removes prostaglandin protection of the stomach lining |
| Coherence | met | Coheres with the labelled gastrointestinal warnings |
| Experiment | met | Randomized and observational studies directly quantify the gastrotoxicity |
| Analogy | met | Analogous to GI bleeding with other NSAIDs, including the withdrawn rofecoxib |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for ibuprofen captured gastrointestinal bleeding as a coded event; the risk is established from randomized gastroprotection studies and large observational cohorts rather than a single trial AE table.