European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
Audiovestibular adverse event reporting profiles of GLP-1 receptor agonists: A case-case pharmacovigilance study using FDA AEMS data.
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Wang Xianwen, Du Danyi, Liu Rong, Zheng Hairui
Аннотация
PURPOSE: 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).
METHODS: We performed a retrospective case-level analysis of AEMS reports through 2026 Q1. Reports naming exenatide, liraglutide, dulaglutide, lixisenatide, or semaglutide as the primary suspect and containing at least one prespecified audiovestibular MedDRA preferred term were deduplicated by case. Among adequately represented agents, phenotype composition was compared using chi-square testing, and case-case comparative reporting odds ratios (cRORs) were calculated for six common preferred terms with Benjamini-Hochberg correction. Time to onset (TTO) was summarized descriptively.
RESULTS: We identified 1,950 unique reports: exenatide 576, liraglutide 192, dulaglutide 622, lixisenatide 1, and semaglutide 559. Hypoacusis (46.9%), vertigo (27.7%), tinnitus (12.7%), and deafness (7.9%) were most frequent. Phenotype composition differed across the four adequately represented agents (chi-square = 78.12, P < 0.001; Cramer V = 0.142). Dulaglutide reports were enriched for hypoacusis (cROR 3.06, 95% CI 2.51-3.74), whereas liraglutide and semaglutide reports were enriched for vertigo and tinnitus. Median TTO was 3 days (IQR 0-35), but valid dates were available for only 19.3% of reports.
CONCLUSION: Individual GLP-1 RAs showed distinct audiovestibular reporting compositions. These findings are hypothesis-generating and do not establish incidence, comparative safety, or causality.
METHODS: We performed a retrospective case-level analysis of AEMS reports through 2026 Q1. Reports naming exenatide, liraglutide, dulaglutide, lixisenatide, or semaglutide as the primary suspect and containing at least one prespecified audiovestibular MedDRA preferred term were deduplicated by case. Among adequately represented agents, phenotype composition was compared using chi-square testing, and case-case comparative reporting odds ratios (cRORs) were calculated for six common preferred terms with Benjamini-Hochberg correction. Time to onset (TTO) was summarized descriptively.
RESULTS: We identified 1,950 unique reports: exenatide 576, liraglutide 192, dulaglutide 622, lixisenatide 1, and semaglutide 559. Hypoacusis (46.9%), vertigo (27.7%), tinnitus (12.7%), and deafness (7.9%) were most frequent. Phenotype composition differed across the four adequately represented agents (chi-square = 78.12, P < 0.001; Cramer V = 0.142). Dulaglutide reports were enriched for hypoacusis (cROR 3.06, 95% CI 2.51-3.74), whereas liraglutide and semaglutide reports were enriched for vertigo and tinnitus. Median TTO was 3 days (IQR 0-35), but valid dates were available for only 19.3% of reports.
CONCLUSION: Individual GLP-1 RAs showed distinct audiovestibular reporting compositions. These findings are hypothesis-generating and do not establish incidence, comparative safety, or causality.