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Causality: well established
Causality assessment · Causality: well established
Testosterone Undecanoate and Cough: 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.
Testosterone Undecanoate ↔ Cough
n=153 co-reports · PRR 6.0 · ROR 6.4
Aspirin is an NSAID/antiplatelet agent. Rectal haemorrhage is a known GI adverse effect of NSAIDs due to COX-1 inhibition. 1,804 co-reports (PRR 7.1) reflect the enormous OTC population and real but modest GI bleeding risk. The label includes warnings about GI bleeding.
Label: aspirin PI (GI bleeding). Gastroenterology 2019, PMID: 31617686.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 7.1 with 1,804 co-reports |
| Consistency | met | Reproduced across NSAID class |
| Specificity | not established | Not specific to aspirin |
| Biological gradient | met | Correlates with daily dose and duration |
| Plausibility | met | Known COX-1 mechanism |
| Coherence | met | Coherent with NSAID pharmacology |
| Experiment | met | Multiple RCTs confirm |
| Analogy | met | Other NSAIDs produce similar GI effects |
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 Testosterone captured cough as a tracked adverse event in a usable structure. GI bleeding is a standard AE endpoint in NSAID/aspirin long-term trials.