Safety Signals of GLP ‐1 Receptor Agonists: A Multi‐Method Pharmacovigilance Analysis of FAERS (2018–2025) With Sensitivity‐Stratified Prioritisation, Notoriety‐Bias Assessment, and Cross‐Database Validation
Authors' conclusion
As disproportionality analyses, these are hypothesis-generating safety signals and cannot establish incidence, relative risk, or causality.
Study context
- Population
- FAERS reports, 32 quarterly files (2018Q1–2025Q4)32 quarterly FAERS files
- Participants
- 288,408 vs 11,319,150
- Comparison
- GLP-1 RA reports vs non-GLP-1 RA reports
- GLP-1 RAn = 288,408
- Non-GLP-1 RAn = 11,319,150reference
- Outcome
- Disproportionality signals
Methodological detailsFAERS 2018Q1-2025Q4, four disproportionality methods (ROR, PRR, BCPNN IC025, MGPS EB05; signal = ≥ 3 of 4), primary-suspect sensitivity stratification, active-comparator, interrupted time-series, Weber-effect evaluation, external validation in JADER
- FAERS 2018Q1-2025Q4
- Four disproportionality methods (ROR, PRR, BCPNN IC025, MGPS EB05; signal = ≥ 3 of 4)
- Primary-suspect sensitivity stratification
- Active-comparator
- Interrupted time-series
- Weber-effect evaluation
- External validation in JADER
Performance
As reported in the abstract
- PT-class pairs
- 22 059
- Met ≥ 3-of-4 criterion
- 544
- Top 30 signals retained after primary-suspect (PS)-stratification
- 21
- Demoted as secondary-suspect-driven
- 9
- Cyclic vomiting syndrome ROR (semaglutide-dominant)
- 64.8
- Gallbladder injury ROR
- 84.2
- Impaired gastric emptying ROR
- 45.1
- Medullary thyroid cancer ROR (liraglutide-concentrated)
- 41.1
- Optic ischaemic neuropathy ROR (semaglutide-concentrated)
- 26.5
- Suicidal ideation ROR, semaglutide only class-level signal
- 2.30
Further findings
Reporting around 2023 EMA announcement (interrupted time series)
- No level change
- P = 0.39
- No slope change
- P = 0.75
Psychiatric time-to-onset
- Median time-to-onset, aligned with early GI reactions
- 47 days
Replication in JADER
- Priority signals replicated
- 16 of 17 (94.1%)
Original publication
Safety Signals of GLP ‐1 Receptor Agonists: A Multi‐Method Pharmacovigilance Analysis of FAERS (2018–2025) With Sensitivity‐Stratified Prioritisation, Notoriety‐Bias Assessment, and Cross‐Database Validation. Diabetes Obes Metab. Published 21 July 2026. doi:10.
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