Real‐World Adverse Event Reporting Patterns of Tirzepatide Versus Semaglutide: A Stratified Study of General and Healthcare Professional Cohorts in FAERS
Main finding · GI disorders reporting (general population)Result — go to the resultGI RORR 0.58 95% CI 0.57–0.59Authors' conclusion
This FAERS-based analysis identifies distinct AE reporting patterns between tirzepatide and semaglutide that are sensitive to reporter type; all findings are hypothesis-generating and require confirmation with defined exposure denominators.
Study context
- Population
- FAERS adverse event reports, May 2022-June 2026; Healthcare professional (HCP) reports 5.04% vs 23.42%FAERS reports
- Participants
- 151,654 vs 64,987
- Comparison
- Tirzepatide vs semaglutide
- Tirzepatiden = 151,654
- Semaglutiden = 64,987reference
- Outcome
- GI disorders reporting (general population)
Methodological detailsdisproportionality analysis of FAERS, four-method signal convergence (ROR, PRR, information component (IC), empirical Bayes geometric mean (EBGM)), Benjamini-Hochberg false discovery rate (FDR), stratified general population and HCP-restricted cohorts, sensitivity analyses by indication, seriousness, geography and calendar quarter
- Disproportionality analysis of FAERS
- Four-method signal convergence (ROR, PRR, IC, EBGM)
- Benjamini-Hochberg FDR
- Stratified general population and HCP-restricted cohorts
- Sensitivity analyses by indication, seriousness, geography and calendar quarter
Main finding
As reported in the abstract
GI RORR
0.58
95% CI 0.57–0.59
By group
Semaglutide
- GI ROR
- 3.64
- Metabolic disorders ROR
- 4.25
Semaglutide
GI ROR3.64
Metabolic disorders ROR4.25
Further findings
| Outcome | Tirzepatide | Semaglutide | RORR (95% CI) |
|---|---|---|---|
| Diabetic ketoacidosis reporting, HCP cohort | |||
| ROR | — not stated in the abstract | 3.52 | |
| Hypoglycaemia reportingHigher hypoglycaemia reporting with tirzepatide | 1.91 (1.49–2.44) | ||
| Gastrointestinal and eye disorder reporting, HCP cohort | |||
| GI ROR | 2.53 | — not stated in the abstract | |
| Eye disorders ROR | — not stated in the abstract | 2.61 | |
| Metabolic disorders reporting, general population | |||
| ROR | — not stated in the abstract | 4.25 |
— not stated in the abstract
Pancreatitis reporting within T2D
- Pancreatitis signalled for both agents but attenuated to equivalence within T2D
- RORR 0.98 (95% CI 0.83-1.15)
Diabetic ketoacidosis reporting, HCP cohort
- DKA signalled exclusively for semaglutide in the HCP cohort
Metabolic disorders reporting, general population
- Only semaglutide met four-method criteria for metabolic disorders
Sensitivity analyses (indication, seriousness, geography, calendar quarter)
- All sensitivity analyses confirmed directional stability of comparative reporting patterns across subgroups
Original publication
Real‐World Adverse Event Reporting Patterns of Tirzepatide Versus Semaglutide: A Stratified Study of General and Healthcare Professional Cohorts in FAERS. Diabetes Obes Metab. Published 21 September 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →