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

Wang X, Du D, Liu R, Zheng H

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 Surgery13 Oct 2026

PMID42867646DOI10.1007/s00405-026-10708-9PepBankPUB-42867646

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

1 result from studies that gave the peptide. 1 result from people.

01HumanObservational studySafety outcome
In adverse-event reports, dulaglutide was linked to greater hypoacusis reporting than other adequately represented agents.
In plain wordsDulaglutide reports were linked to more hearing-loss reporting than reports for other adequately represented agents.
Peptide
Dulaglutide (Trulicity)
Outcome
IncreaseHypoacusis reporting
Study
n: not reported in source
Comparator
Other adequately represented GLP-1 receptor agonists
Outcome group
Adverse events · Nervous system and cognition
Studied dose
Dose not stated
Measurements
Comparative reporting odds ratio
3.06 ratio
hypoacusis
Lower confidence limit
2.51 ratio
95% CI
Upper confidence limit
3.74 ratio
95% CI
Source sentences
Summary
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.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a retrospective case-level analysis of AEMS reports through 2026 Q1.
Summary · context
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.
Report a problemFND-4286764601

Studies that did not test the peptide alone6

In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Dulaglutide (Trulicity).

02HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
Among pooled GLP-1RA audiovestibular reports, including dulaglutide, hypoacusis accounted for 46.9%.
In plain wordsAmong pooled hearing and balance reports for GLP-1RAs including dulaglutide, 46.9% reported reduced hearing.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicablePooled hypoacusis report frequency
Study
n = 1,950
Outcome group
Adverse events · Nervous system and cognition
Measurements
Hypoacusis report frequency
46.9%
pooled agents
Source sentences
Summary
Hypoacusis (46.9%), vertigo (27.7%), tinnitus (12.7%), and deafness (7.9%) were most frequent.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a retrospective case-level analysis of AEMS reports through 2026 Q1.
Summary · context
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.
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Report a problemFND-4286764602
03HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
Among pooled GLP-1RA audiovestibular reports, including dulaglutide, vertigo accounted for 27.7%.
In plain wordsAmong pooled hearing and balance reports for GLP-1RAs including dulaglutide, 27.7% reported vertigo.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicablePooled vertigo report frequency
Study
n = 1,950
Outcome group
Adverse events · Nervous system and cognition
Measurements
Vertigo report frequency
27.7%
pooled agents
Source sentences
Summary
Hypoacusis (46.9%), vertigo (27.7%), tinnitus (12.7%), and deafness (7.9%) were most frequent.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a retrospective case-level analysis of AEMS reports through 2026 Q1.
Summary · context
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.
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Report a problemFND-4286764603
04HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
Among pooled GLP-1RA audiovestibular reports, including dulaglutide, tinnitus accounted for 12.7%.
In plain wordsAmong pooled hearing and balance reports for GLP-1RAs including dulaglutide, 12.7% reported tinnitus.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicablePooled tinnitus report frequency
Study
n = 1,950
Outcome group
Adverse events · Nervous system and cognition
Measurements
Tinnitus report frequency
12.7%
pooled agents
Source sentences
Summary
Hypoacusis (46.9%), vertigo (27.7%), tinnitus (12.7%), and deafness (7.9%) were most frequent.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a retrospective case-level analysis of AEMS reports through 2026 Q1.
Summary · context
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.
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Report a problemFND-4286764604
05HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
Among pooled GLP-1RA audiovestibular reports, including dulaglutide, deafness accounted for 7.9%.
In plain wordsAmong pooled hearing and balance reports for GLP-1RAs including dulaglutide, 7.9% reported deafness.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicablePooled deafness report frequency
Study
n = 1,950
Outcome group
Adverse events · Nervous system and cognition
Measurements
Deafness report frequency
7.9%
pooled agents
Source sentences
Summary
Hypoacusis (46.9%), vertigo (27.7%), tinnitus (12.7%), and deafness (7.9%) were most frequent.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a retrospective case-level analysis of AEMS reports through 2026 Q1.
Summary · context
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.
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Report a problemFND-4286764605
06HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
In pooled GLP-1RA reports including dulaglutide, median onset was 3 days, with valid dates in only 19.3% of reports.
In plain wordsIn pooled reports including dulaglutide, median onset was 3 days, but only 19.3% had valid dates.
Peptide
Dulaglutide (Trulicity)
Outcome
Not applicablePooled audiovestibular event onset
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Measurements
Median onset
3 days
pooled agents
Onset IQR
0 to 35 days
pooled agents
Valid dates
19.3%
reports
Source sentences
Summary
Median TTO was 3 days (IQR 0-35), but valid dates were available for only 19.3% of reports.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a retrospective case-level analysis of AEMS reports through 2026 Q1.
Summary · context
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.
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Report a problemFND-4286764606
07HumanNot a test of Dulaglutide (Trulicity) aloneObservational studySafety outcome
In audiovestibular reports, phenotype composition differed across four adequately represented GLP-1RAs, including dulaglutide.
In plain wordsHearing and balance report patterns differed across four adequately represented GLP-1RAs, including dulaglutide.
Peptide
Dulaglutide (Trulicity)
Outcome
MixedAudiovestibular phenotype composition across agents
Study
n: not reported in source
Comparator
Other adequately represented agents
Outcome group
Adverse events · Nervous system and cognition
Measurements
Chi-square
78.12 chi-square statistic
phenotype composition across four agents
Cramer V
0.142 effect size
phenotype composition across four agents
Source sentences
Summary
Phenotype composition differed across the four adequately represented agents (chi-square = 78.12, P < 0.001; Cramer V = 0.142).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a retrospective case-level analysis of AEMS reports through 2026 Q1.
Summary · context
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.
In this study, Dulaglutide (Trulicity) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Dulaglutide (Trulicity).
Report a problemFND-4286764607

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
27 Oct 2026, 16:36 UTC
Study data updated · source update from Europe PMC
Version 2
22 Oct 2026, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Journal Article

Keywords

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