Oral Health-Related Adverse Events of GLP-1 Receptor Agonists
- Design
- Pharmacovigilance · 364274 participants · Intermediate outcome
- Match to healthy normal-weight adults aged 55–75
- Population unclearUNKNOWN: the analysis counts adverse-event reports rather than describing people, and gives no age, sex, BMI or diabetes data, so the population is not determinable.
- Could weight loss explain it?
- PossiblyPossibly: no weight, HbA1c or mediation data are reported, so the oral events cannot be separated from weight loss, reduced food and fluid intake or metabolic change.
- Study tier
- Study tier 4VERY_LOW: a pharmacovigilance disproportionality analysis of spontaneous FAERS reports, which sits at study tier 4. It has no denominator, no comparator group and no effect sizes, so it can show what gets reported, not how often events occur or whether the drugs cause them.
- Assessment
- Version 2 · Two independent AI reviews agreed · Nov 6, 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.
Researchers screened reports sent to the US FDA's adverse-event system for five GLP-1 drugs - exenatide, liraglutide, semaglutide, dulaglutide and tirzepatide - from each drug's market introduction through December 2025, finding 364,274 reports of which 31,195 (8.6%) involved the mouth, face or teeth. Dry mouth stood out for semaglutide, vomiting, regurgitation and reflux across all five drugs, and taste disturbances for several of them. Spontaneous reports show what gets reported rather than how often problems happen or whether the drug caused them, and the analysis gives no figures for the signals it calls significant.
01Findings
What the study reported
- Drugs
- Exenatide, Liraglutide, Semaglutide, Dulaglutide, Tirzepatide
- Comparator
- not reported in abstract
- Primary outcome
- oral, craniofacial and dental adverse events reported for GLP-1 receptor agonists (dry mouth, vomiting, regurgitation, reflux, dysgeusia and taste disturbance)
- Effect
- No effect sizes are reported. Of 364,274 total AE reports, 31,195 (8.6%) involved oral, craniofacial or dental manifestations; a significant drug-specific signal for dry mouth with semaglutide; significant signals for vomiting, regurgitation and reflux-related events across all 5 drugs; significant proportional reporting ratios and reporting odds ratios for dysgeusia and taste disturbances for several drugs; tirzepatide had the highest overall AE volume and semaglutide the largest proportion of oral AEs.
- 95% confidence interval
- not reported in abstract
- Follow-up
- Not stated
- Adverse events
- Dry mouth signalled for semaglutide; vomiting, regurgitation and reflux-related events signalled across all 5 drugs; dysgeusia and taste disturbances showed significant proportional reporting ratios and reporting odds ratios for several drugs; vomiting was associated with taste disturbances and dry mouth with dysgeusia, particularly for semaglutide and dulaglutide.
- Limitations
- Spontaneous reports give no denominator, incidence or causal inference, and no comparator, effect size or interval is reported; reporting is open to notoriety and channelling bias, and no age, sex or clinical data for the reported cases are given. The authors call for prospective studies to characterise incidence, timing and mechanisms.
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
- not reported in abstract
- Sample size
- 364274
- Inclusion exclusion
- FAERS reports for exenatide, liraglutide, semaglutide, dulaglutide and tirzepatide, screened from each drug's initial market introduction through December 2025
Study quality details
- Study design
- Pharmacovigilance analysis
- Sample size
- 364274
- Randomization
- no
- Blinding
- n/a
- Comparator
- not reported in abstract
- Follow up duration
- not stated
- Outcome type
- intermediate
- Replication
- not assessed
- Consistency with other evidence
- not assessed
- Population applicability
- UNKNOWN
- Statistical precision
- no confidence intervals or values for the proportional reporting ratios and reporting odds ratios; 31,195 of 364,274 reports involved oral, craniofacial or dental manifestations
- Risk of bias
- not assessed
- 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
- not reported in abstract
- Independent replication
- unknown
Funding is shown on every study and never used to score it.
04Source
The source, as retrieved
Abstract
[INTRODUCTION] As the clinical use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) continues to grow for the management of type 2 diabetes, cardiovascular and renal protection, noncirrhotic fatty liver disease, and weight management, their potential implications for oral health need to be considered. [OBJECTIVES] This study examined oral health-related adverse events (AEs) associated with GLP-1 RAs using postmarketing data from the US Food and Drug Administration Adverse Event Reporting System (FAERS). [METHODS] FAERS reports for available GLP-1 RAs, exenatide, liraglutide, semaglutide, dulaglutide, and tirzepatide, were screened from their initial market introduction through December 2025, identifying 364,274 total AE reports, of which 31,195 (8.6%) involved oral, craniofacial, or dental manifestations. [RESULTS] Tirzepatide, despite being one of the most recently approved GLP-1 RAs, accounted for the highest overall AE volume, and semaglutide demonstrated the largest proportion of oral health-related AEs. A disproportionality analysis revealed a significant drug-specific signal for dry mouth of semaglutide, while vomiting, regurgitation, and reflux-related events produced a significant signal across all 5 drugs. Sensory disorders, including dysgeusia and taste disturbances, also demonstrated significant proportional reporting ratios (PRRs) and reporting odds ratios (RORs) for several GLP-1 RAs. Association analysis of AEs showed significant associations between vomiting and taste disturbances, as well as between dry mouth and dysgeusia, particularly with semaglutide and dulaglutide. [CONCLUSION] This analysis highlights emerging safety signals in oral health and underscores the need for heightened clinical awareness and prospective studies to characterize the incidence, timing, and mechanisms of oral AEs associated with GLP-1 RA therapy.Knowledge Transfer Statement:Understanding the oral adverse effects associated with GLP-1 receptor agonists allows clinicians and dental providers to more effectively counsel patients initiating or continuing these medications. By recognizing early symptoms such as dry mouth, dysgeusia, and reflux-related irritation, providers can implement targeted preventive strategies-including hydration guidance, salivary substitutes, dietary modifications, and closer oral health monitoring-to reduce complications and improve patient comfort, adherence, and overall treatment outcomes. This knowledge enhances interdisciplinary management of individuals using GLP-1 RAs.
Where this record came from
| Source | Retrieved | Identifier |
|---|---|---|
| pubmed | Nov 1, 2026 | 42935458 first ingestion |
| pubmed | Nov 1, 2026 | 42935458 duplicate matched on doi |
| pubmed | Nov 1, 2026 | 42935458 duplicate matched on doi |
| pubmed | Nov 1, 2026 | 42935458 duplicate matched on doi |
| owner-review | Nov 6, 2026 | reviewed_by set to Carrie Schluter (2026-11-05) on the owner's own confirmation. The assessment is unchanged and still the auto-classifier's, so its extracted values stay withheld under the 2026-10-18 decision. |
| pubmed | Nov 8, 2026 | 42935458 duplicate matched on doi |
| pubmed | Nov 8, 2026 | 42935458 duplicate matched on doi |
| pubmed | Nov 8, 2026 | 42935458 duplicate matched on doi |
| pubmed | Nov 8, 2026 | 42935458 duplicate matched on doi |