--- title: "Tirzepatide safety signals in EudraVigilance: reports of suboptimal outcomes and drug-use issues" id: "bmj-open-2-tirzepatide-safety-in-eudravigilance-descriptive-and-disproportionality" canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-2-tirzepatide-safety-in-eudravigilance-descriptive-and-disproportionality" content_type: "clinical_feed_article" specialty: "Pharmacology" source_name: "BMJ Open" source_url: "http://bmjopen.bmj.com/cgi/content/short/16/10/e120507?rss=1" published_at: "2026-10-01T11:56:34.000Z" evidence_level: "Journal Feed" license: "CC-BY-NC-4.0 / Informational Use" --- # Tirzepatide safety signals in EudraVigilance: reports of suboptimal outcomes and drug-use issues ## Provenance & Clinical Metadata - **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-2-tirzepatide-safety-in-eudravigilance-descriptive-and-disproportionality - **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md) - **Primary Source:** BMJ Open - **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/10/e120507?rss=1) - **Published At:** 2026-10-01T11:56:34.000Z - **Evidence Rating:** Journal Feed ## Executive GIST (TL;DR) - This retrospective pharmacovigilance study mined the EudraVigilance (EV) database to identify reporting patterns for **tirzepatide**, a dual GIP/GLP-1 receptor agonist used for weight loss and diabetes. - The analysis compared individual case safety reports for tirzepatide with those for other **GLP-1 receptor agonists** using descriptive counts and disproportionality (reporting odds ratios, RORs) for selected Preferred Terms (PTs) related to suboptimal therapeutic outcomes and drug-use issues. - The most frequently reported PTs for tirzepatide were **Off-label use** (n=1521), **Drug ineffective** (n=425) and **Off-label use device** (n=99). - PTs reported by healthcare professionals (HP) had lower reporting odds than those from non-HP reporters in the dataset. - In the overall dataset, tirzepatide reports showed lower RORs for **Drug ineffective** versus liraglutide (ROR 0.61, 95% CI 0.54–0.70), dulaglutide (ROR 0.72, 95% CI 0.63–0.82), exenatide (ROR 0.78, 95% CI 0.67–0.92) and semaglutide (ROR 0.81, 95% CI 0.72–0.91). - No difference in reporting odds for **Drug ineffective** was observed between tirzepatide and semaglutide when analyses were limited to HP reports. - For **Off-label use**, tirzepatide showed higher reporting odds versus lixisenatide, dulaglutide and liraglutide in the full dataset, but lower odds versus semaglutide (ROR 0.52, 95% CI 0.49–0.55). - A notably higher reporting odd for **Off-label use device** was observed for tirzepatide versus semaglutide in the overall reports (ROR 43.47, 95% CI 16.00–118.13), but the wide confidence interval warrants cautious interpretation. - The study states it complements clinical trial and practice evidence. Specifics such as absolute numbers beyond those reported, timeframes, case-level details, and causality assessments were not reported in the source. ## Clinical Analysis & Structured Key Points 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. ## Related Clinical Research - [Factors Driving Weight Loss Variability with GLP-1 Receptor Agonists and Dual Agonists in Obesity:](https://medichelpline.com/clinical-feed/pubmed-42733128.md) (DOI: 10.1111/cob.70112) - [GLP‑1 and Dual GIP/GLP‑1 Receptor Agonists: Psychopharmacology and Potential Neuropsychiatric Effe](https://medichelpline.com/clinical-feed/pubmed-42624955.md) (DOI: 10.1007/s11920-026-01709-w) - [Semaglutide plus menopause hormone therapy linked to greater weight loss in midlife women](https://medichelpline.com/clinical-feed/medical-news-today-0-ozempic-plus-hormone-therapy-may-help-boost-weight-loss-at-menopause.md) - [Digital-first delivery of GLP-1RA therapy in 8,127 women](https://medichelpline.com/clinical-feed/nature-3-real-world-digital-first-delivery-of-glp-1-receptor-agonist-therapy-in-women.md) - [12-Month Real-World Weight Loss With Individualized Nutrition Plus Incretin-Based Therapies](https://medichelpline.com/clinical-feed/medrxiv-15-real-world-twelve-month-weight-loss-outcomes-in-a-comprehensive-obesity-care.md) ## Navigation - [← Back to Pharmacology Feed](https://medichelpline.com/clinical-feed/pharmacology.md) - [← All Clinical Specialties](https://medichelpline.com/clinical-feed.md) ## Medical & Regulatory Disclaimer > [!CAUTION] > MedicHelpline content is structured for research, educational, and professional discovery purposes. 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