Causality assessment · Causality: well established

Sertraline (SSRIs) and Upper gastrointestinal bleeding: is the FAERS signal real?

n=361 co-reports · PRR 3.9 · ROR 3.9

Sertraline (SSRIs) side-effect profile All assessments See in the full list

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.

Causality: well established

Sertraline (SSRIs) ↔ Upper gastrointestinal bleeding

n=361 co-reports · PRR 3.9 · ROR 3.9

SSRIs such as sertraline impair platelet serotonin uptake, and because platelets depend on serotonin for aggregation, this produces a modestly increased bleeding tendency — most clearly seen as upper gastrointestinal bleeding, especially when combined with NSAIDs, aspirin, or anticoagulants. The risk is a class effect, is not dose-specific in a simple way, and is an important drug-interaction consideration. The 361 co-reports (PRR 3.9) reflect both the real association and the enormous number of people taking SSRIs.

Regulatory basis: sertraline/SSRI labelling warnings on abnormal bleeding, especially with NSAIDs/anticoagulants. Established SSRI-GI-bleeding observational literature.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Bleeding occurs during treatment and resolves after withdrawal
Strength	partial	PRR 4 on a moderate co-report count
Consistency	met	Reproduced across SSRI cohorts and case-control studies
Specificity	partial	A class effect across SSRIs, amplified by other bleeding-risk drugs
Biological gradient	partial	Risk rises with age, and with NSAID, aspirin, or anticoagulant co-therapy
Plausibility	met	Impaired platelet serotonin uptake reduces platelet aggregation
Coherence	met	Coheres with the labelled bleeding/interaction warnings
Experiment	partial	Observational; no randomized trial has tested bleeding outcomes
Analogy	met	Analogous to bleeding risk with other SSRIs and serotonin-reuptake-inhibiting drugs

This page's own qualitative read, not an automated/citation-gated assessment.

✗ No ClinicalTrials.gov results-posting trial in the top search hits for sertraline captured gastrointestinal bleeding; the risk is small and was identified through large observational studies, not a trial AE table.