Gentamicin (aminoglycosides) and Ototoxicity (hearing/balance): is the FAERS signal real?
Gentamicin (aminoglycosides) ↔ Ototoxicity (hearing/balance)
Aminoglycosides such as gentamicin damage the hair cells of the inner ear, producing hearing loss and vestibular (balance) disturbance that can be permanent. The toxicity is dose- and duration-related, is worsened by other ototoxic drugs (loop diuretics, vancomycin) and by renal impairment (which raises drug levels), and is the reason aminoglycoside courses are kept short and, where possible, guided by drug-level monitoring. The 94 co-reports (PRR 86.1) reflect a genuine and serious effect of a drug still widely used for serious infections.
Regulatory basis: gentamicin prescribing information (ototoxicity and nephrotoxicity warnings; therapeutic drug monitoring). Established aminoglycoside-ototoxicity literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Hearing/balance damage occurs during exposure and may be irreversible |
| Strength | met | PRR 86 on a modest co-report count — a strong relative signal |
| Consistency | met | Reproduced across the aminoglycoside class and in audiology studies |
| Specificity | met | A classic aminoglycoside toxicity, though other drugs can also damage the ear |
| Biological gradient | met | Risk rises with dose, duration, renal impairment, and other ototoxic drugs |
| Plausibility | met | Inner-ear hair-cell damage by the aminoglycoside is the defined mechanism |
| Coherence | met | Coheres with the labelled monitoring and short-course practice |
| Experiment | partial | Dechallenge (withdrawal) limits further loss but does not reverse it; no randomized trial |
| Analogy | met | Analogous to ototoxicity with other aminoglycosides and loop diuretics |
This page's own qualitative read, not an automated/citation-gated assessment.