Audiovestibular adverse event reporting profiles of GLP-1 receptor agonists: A case-case pharmacovigilance study using FDA AEMS data
- Design
- Pharmacovigilance · 1950 participants · Intermediate outcome
- Match to healthy normal-weight adults aged 55–75
- Population unclearUNKNOWN: spontaneous adverse-event reports with no age, BMI or diabetes data in the abstract.
- Could weight loss explain it?
- PossiblyNo weight, HbA1c or mediation data are reported, so a drug effect cannot be separated from weight or metabolic change.
- Study tier
- Study tier 4VERY_LOW: a pharmacovigilance analysis of spontaneous reports, which the authors call hypothesis-generating.
- Assessment
- Version 3 · Two independent AI reviews agreed · Oct 19, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
This study looked at 1,950 FDA adverse-event reports of hearing or balance problems naming a GLP-1 receptor agonist. The most common reported problems were reduced hearing (46.9%), vertigo (27.7%), tinnitus (12.7%) and deafness (7.9%), and the mix differed by drug, with dulaglutide reports more often about reduced hearing. Report databases cannot show how often these problems occur or whether the drugs cause them, as the authors note.
01Findings
What the study reported
- Drugs
- Exenatide, Liraglutide, Dulaglutide, Lixisenatide, Semaglutide
- Comparator
- other GLP-1 receptor agonists (case-case comparison)
- Primary outcome
- Audiovestibular adverse-event reporting patterns across GLP-1 RAs
- Effect
- Phenotype composition differed across agents (chi-square = 78.12, P < 0.001); dulaglutide reports enriched for hypoacusis (cROR 3.06, 95% CI 2.51-3.74); liraglutide and semaglutide reports enriched for vertigo and tinnitus.
- 95% confidence interval
- 95% CI 2.51-3.74
- P value
- P < 0.001
- Follow-up
- Not stated
- Adverse events
- Most frequent reported terms: hypoacusis (46.9%), vertigo (27.7%), tinnitus (12.7%), deafness (7.9%); median time to onset 3 days (IQR 0-35), with valid dates for only 19.3% of reports.
- Limitations
- Spontaneous reports with no denominator, so no incidence, comparative safety or causality; onset dates were valid for only a minority of reports.
Who was studied
- Obesity status
- not reported in abstract
- Diabetes status
- not reported in abstract
- Cvd status
- not reported in abstract
- Ckd status
- not reported in abstract
- Baseline condition
- spontaneous FDA adverse-event reports naming a GLP-1 receptor agonist as primary suspect with an audiovestibular term
- Sample size
- 1950
- Inclusion exclusion
- reports with a GLP-1 RA as primary suspect and at least one prespecified audiovestibular term, deduplicated by case
Study quality details
- Study design
- Pharmacovigilance analysis
- Sample size
- 1950
- Randomization
- no
- Blinding
- n/a
- Comparator
- other GLP-1 receptor agonists (case-case comparison)
- Follow up duration
- not stated
- Outcome type
- intermediate
- Replication
- not assessed
- Consistency with other evidence
- not assessed
- Population applicability
- UNKNOWN
- Statistical precision
- CI reported: 95% CI 2.51-3.74
- Risk of bias
- not assessed
- Funding conflicts
- unclear
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- not reported in abstract
- Industry funded
- Unclear
- Manufacturer
- not stated in source
- Sponsor role
- not reported in abstract
- Author conflicts
- The authors report no relevant financial or non-financial interests.
- Independent replication
- unknown
Funding is shown on every study and never used to score it.
04Source
The source, as retrieved
Abstract
[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.
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Oct 18, 2026 | 42867646 first ingestion |