ArticleFrontiers in pharmacology2024
A real-world data analysis of tirzepatide in the FDA adverse event reporting system (FAERS) database.
Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed.
- Article
- Incretin-Based Drugs for Obesity: Common and Drug-Specific Reporting Patterns of Adverse Drug Reactions-A Comparative Disproportionality Analysis Using EudraVigilance Reports Integrating SmPC Data.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Beyond weight loss: Effect of GLP-1 receptor agonist therapy on the urological health.Urology case reports · 2026Article
- Adverse events associated with tirzepatide: a focus on subgroup-specific differences.BMC pharmacology & toxicology · 2026Article
- Article
- Comparative Safety of GLP-1 Receptor Agonists Across Gastrointestinal, Renal and Pancreatic Systems.Pharmaceuticals (Basel, Switzerland) · 2026Article
- GLP-1/GIP dual agonist tirzepatide in obstructive sleep apnea syndrome: mechanisms, evidence, and clinical perspectives.Frontiers in medicine · 2026Review
- Tirzepatide for obesity without diabetes: mechanistic insights, clinical evidence, and future directions.Frontiers in pharmacology · 2026Review
- Haematological toxicity associated with antineoplastic drugs: a pharmacovigilance analysis based on the FDA adverse event reporting system database.Frontiers in immunology · 2026Article
- Gastrointestinal adverse events associated with tirzepatide: A bibliometric and pharmacovigilance analysis.PloS one · 2026Article
- Real-World Safety Concerns of Tirzepatide: A Retrospective Analysis of FAERS Data (2022-2025).Healthcare (Basel, Switzerland) · 2025Article
- Immune checkpoint inhibitor-associated myocarditis and pericarditis: a pharmacovigilance study based on the FAERS database.BMC cancer · 2025Article
- Tirzepatide safety in type 2 diabetes: a disproportionality analysis of adverse events using the FDA FAERS database.Endocrine connections · 2025Article
- Comparative Safety of GLP-1/GIP Co-Agonists Versus GLP-1 Receptor Agonists for Weight Loss in Patients with Obesity or Overweight: A Systematic Review.Diabetes, metabolic syndrome and obesity : targets and therapy · 2025Review
- A real-world disproportionality analysis of ripretinib data mining of the public version of FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- Analysis of tirzepatide in the US FDA adverse event reporting system (FAERS): a focus on overall patient population and sex-specific subgroups.Frontiers in pharmacology · 2024Article
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Tirzepatide, a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, is indicated for chronic weight management in adults with obesity or overweight as an adjunct to a reduced-calorie diet and increased physical activity. However, the safety profile of Tirzepatide-associated adverse events requires comprehensive evaluation. Methods: The AE reports from the first quarter of 2022 to the third quarter of 2023 were selected by exploring the FDA Adverse Event Reporting System (FAERS) database. The new and unexpected potenial AE signals were detected using the disproportionality analysis, including reporting odds ratio(ROR), the proportional reporting ratio (PRR) the Bayesian confidence propagation neural network (BCPNN) and the empirical Bayes geometric mean(EBGM). Then the MedDRA was used to systematically classify the results. Results: A total of 1,904,481 case reports were obtained from 2022Q2 to 2023Q3. Forty-sixth tirzepatide-induced ADRs at the preferred terms (PTs) level are associated with 8 system organ class In addition, this study uncovered multiple anticipated ADRs, such as gastrooesophageal reflux disease, dyspepsia, and vomiting, in line with the drug labels. Moreover, unexpected and significant ADRs at PTs level, such as incorrect dose administered, injection site haemorrhage, and increased appetite, were discovered and linked to Injury, poisoning, and procedural complications, General disorders and administration site conditions, and Metabolism and nutrition disorders at the System Organ Class level. Conclusion: This study offered new perspectives on the monitoring, surveillance, and management of adverse drug reactions related to tirzepatide. The outcomes of severe adverse events and their respective detection signals, along with unexpected significant adverse event signals, are important to consider in efforts to enhance clinical medication safety when using tirzepatide.
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