Safety Profile of Tirzepatide in Real‐World Clinical Practice: A Pharmacovigilance Study Using the FAERS Database
Authors' conclusion
This FAERS study characterises tirzepatide safety signals in real-world practice. Medication errors and injection-site reactions were the strongest signals.
Study context
- Population
- FAERS reports listing tirzepatide as the primary suspected drug, Q2 2022-Q4 2025; females 62.30%, mean age 53.7 yearsreports
- Participants
- 123,145 reports
- Outcome
- Post-marketing safety signals of tirzepatide
Methodological detailsdisproportionality analysis (ROR, PRR, IC, EBGM), FAERS database, comparative analysis vs semaglutide
- Disproportionality analysis (ROR, PRR, IC, EBGM)
- FAERS database
- Comparative analysis vs semaglutide
Main finding
As reported in the abstract
- Major signals: medication errors, injection-site reactions and gastrointestinal disorders
- Novel unlabelled signals: eructation, hunger, food craving and starvation ketoacidosis
Observational data: associations, not effects.
Further findings
Reporting odds vs semaglutide
- Tirzepatide showed lower reporting odds of vomiting, constipation and decreased appetite vs semaglutide
Time to onset
- Median time to onset
- 13 days
- Occurring within 30 days
- 67.1%
- Among reports with valid onset data
Original publication
Safety Profile of Tirzepatide in Real‐World Clinical Practice: A Pharmacovigilance Study Using the FAERS Database. Diabetes Obes Metab. Published 13 July 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →