Tirzepatide safety in EudraVigilance: descriptive and disproportionality analysis of preferred terms related to suboptimal treatment outcomes and drug-use-related issues
- Design
- Pharmacovigilance
- Drugs
- Semaglutide, Liraglutide, Dulaglutide, Exenatide, Lixisenatide, Tirzepatide
- Assessment
- Not yet reviewed by a person · added Oct 4, 2026
This study was added automatically and has not been reviewed. Until it is, the collection publishes no population match, weight-loss explanation, study tier, findings, population or funding details for it: a check of automatically extracted details found too many errors to show them as fact. The abstract below is the source as retrieved.
01Source
The source, as retrieved
Abstract
[OBJECTIVE] As obesity and diabetes are on the verge of an alarming growth, so is the use of tirzepatide, a novel dual glucose-dependent insulinotropic peptide/glucagon-like peptide-1 (GLP-1) receptor agonist (RA) and currently the most effective weight loss-drug. This research aimed to identify reporting patterns related to suboptimal therapeutic outcomes and tirzepatide-related drug-use issues, mining the EudraVigilance (EV). [DESIGN] Retrospective pharmacovigilance study using descriptive and disproportionality analyses of reports retrieved from the EV database. [SETTINGS] Analysis of individual case safety reports involving tirzepatide in comparison with other GLP-1 RAs in the overall dataset (healthcare professionals (HP) and non-HP reports combined) and in the HP group. [OUTCOME MEASURES] Reporting ORs (RORs) with 95% CIs for selected Preferred Terms (PT) related to drug-use issues. [RESULTS] Among all analysed PTs, the most frequently reported were 'Off-label use' (n=1521), 'Drug ineffective' (n=425) and 'Off-label use device' (n=99). PTs in HP reports showed lower reporting odds compared with non-HP reports. In the overall dataset, reports involving tirzepatide showed lower reporting odds of the PT 'Drug ineffective' than those involving liraglutide (ROR 0.61, 95% CI 0.54 to 0.70), dulaglutide (ROR 0.72, 95% CI 0.63 to 0.82), exenatide (ROR 0.78, 95% CI 0.67 to 0.92) and semaglutide (ROR 0.81, 95% CI 0.72 to 0.91). However, in HP reports, no difference in reporting odds was observed between tirzepatide and semaglutide. A different pattern was observed for 'off-label use' in the full dataset, with higher reporting odds for tirzepatide vs lixisenatide, dulaglutide and liraglutide, but lower reporting odds vs semaglutide (ROR 0.52, 95% CI 0.49 to 0.55). In contrast, a higher reporting odd for the PT 'off-label use of device' was observed for tirzepatide versus semaglutide (ROR 43.47, 95% CI 16.00 to 118.13) in the overall reports; however, this finding should be interpreted with caution given the wide CI. [CONCLUSIONS] This study complements existing evidence from clinical trials and current clinical practice.