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Causality: well established
Causality assessment · Causality: well established
Gentamicin and Ototoxicity: 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.
Gentamicin ↔ Ototoxicity
n=94 co-reports · PRR 86.1 · ROR 86.7
Gentamicin carries a boxed warning for ototoxicity: it damages the cochlea and vestibular apparatus, sometimes irreversibly, with risk rising with high or prolonged levels; 94 co-reports give an extreme PRR of 86.1. The label requires level monitoring and caution in renal impairment.
Regulatory basis: gentamicin prescribing information — boxed warning for ototoxicity; aminoglycoside level and renal monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Days into therapy |
| Strength | met | PRR 86.1, an extreme signal |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to aminoglycosides |
| Biological gradient | met | Level/dose-related |
| Plausibility | met | Known hair-cell toxicity |
| Coherence | met | Fits gentamicin's cochlear effect |
| Experiment | n/a | Hearing testing rarely a trial endpoint |
| Analogy | met | Analogous to amikacin/tobramycin ototoxicity |
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 gentamicin captured ototoxicity as a tracked adverse event in a usable structure. Trials rarely perform audiometry or code hearing loss as a structured adverse event.