Audiovestibular adverse event reporting profiles of GLP-1 receptor agonists: A case-case pharmacovigilance study using FDA AEMS data

To characterize and compare audiovestibular adverse-event reporting patterns among glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in the US Food and Drug Administration Adverse Event Monitoring System (AEMS).

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Audiologists should be alert to potential audiovestibular side effects in patients taking GLP-1 receptor agonists; while pharmacovigilance signal studies cannot prove causation, they provide a basis for proactive hearing and balance monitoring in this rapidly growing patient population.

GLP-1 receptor agonists are among the fastest-growing drug classes globally, and identifying a potential audiovestibular safety signal has immediate relevance for audiologists, prescribers, and drug safety regulators.

1. 01Case-case pharmacovigilance study using FDA Adverse Event Reporting System (FAERS) data.
2. 02GLP-1 receptor agonists (e.g., semaglutide, tirzepatide) are widely prescribed for diabetes and obesity.
3. 03Study characterizes reporting patterns of hearing and balance-related adverse events across this drug class.
4. 04Pharmacovigilance studies detect signals but cannot establish causation.
5. 05Findings may influence monitoring recommendations for audiologists treating patients on these medications.

PMID

42867646

DOI

10.1007/s00405-026-10708-9.

Journal

European Archives of Oto-Rhino-Laryngology

Publication type

research_article

Evidence level

3

Population

Adverse event reports for GLP-1 receptor agonist users in the FDA FAERS database

Intervention

GLP-1 receptor agonist exposure (e.g., semaglutide, liraglutide, tirzepatide)

Comparator

Other drug classes used as case-case comparators within FAERS