Disproportionality analysis of drug-associated tinnitus safety signals: a 43-year pharmacovigilance study

Drug-induced tinnitus is a prevalent yet under-characterised adverse drug reaction. No prior study has systematically screened the FDA Adverse Event Reporting System (FAERS) for drug-tinnitus disproportionality signals using a rigorous, deduplication-validated framework....

Clinicians should be alert to drug-induced tinnitus as a genuine adverse drug reaction across a wider range of medications than currently recognized; specific high-signal drugs identified in this analysis warrant heightened counseling and monitoring, pending peer review of the full results.

A 43-year pharmacovigilance sweep of FAERS is one of the most comprehensive systematic efforts to map drug-induced tinnitus signals, potentially reshaping how audiologists and prescribers counsel patients on medication-related hearing side effects.

1. 0143-year disproportionality analysis of FDA Adverse Event Reporting System (FAERS) data used to detect drug-tinnitus safety signals.
2. 02Drug-induced tinnitus is characterized as an under-studied adverse drug reaction (ADR).
3. 03Disproportionality analysis flags drugs reported with tinnitus far more often than statistical chance would predict.
4. 04Findings could expand the known list of ototoxic or tinnitus-inducing medications beyond established culprits.
5. 05Published in a peer-reviewed pharmacology journal (DOI: 10.1007/s00210-026-05556-7).

PMID

42321578

DOI

10.1007/s00210-026-05556-7.

Journal

Naunyn-Schmiedeberg's Archives of Pharmacology

Publication type

research_article

Evidence level

2b

Population

Drug adverse event reports in the FDA Adverse Event Reporting System (FAERS) spanning 43 years

Intervention

Disproportionality analysis of drug-associated tinnitus adverse event reports

Comparator

Expected background reporting rates for all other adverse events in FAERS