REAL-WORLD SAFETY PROFILE OF TIRZEPATIDE: A DESCRIPTIVE ANALYSIS OF THE FDA ADVERSE EVENT REPORTING SYSTEM (FAERS)

Abstract

Background: Tirzepatide is a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist approved for the management of type 2 diabetes mellitus and obesity. Although clinical trials have demonstrated its efficacy and acceptable safety profile, continuous post-marketing surveillance is essential to identify adverse drug reactions reported during routine clinical use. Real-world pharmacovigilance databases provide valuable information for monitoring the safety of newly introduced medicines across diverse patient populations. Objectives: The present study aimed to evaluate the real-world safety profile of tirzepatide by analyzing adverse event reports available in the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Materials and Methods: A retrospective descriptive pharmacovigilance study was conducted using publicly available reports from the FAERS database. Reports in which tirzepatide was recorded as a suspected drug were included in the analysis. Demographic characteristics, reporter type, frequently reported adverse events, and System Organ Class (SOC) distributions were evaluated using descriptive statistical methods. Results: A total of 158,914 adverse event reports associated with tirzepatide were identified. Among these, 27,118 were classified as serious cases and 821 reported deaths as an outcome. Adults aged 18–64 years represented the largest patient group. Female patients accounted for 61.07% of the reports, while consumers submitted the majority of reports (93.02%). Frequently reported clinical adverse events included nausea, injection-site pain, diarrhoea, vomiting, constipation, abdominal pain, fatigue, and headache. System Organ Class analysis showed that General Disorders and Administration Site Conditions, Gastrointestinal Disorders, and Injury, Poisoning and Procedural Complications were among the most frequently reported categories. Conclusion: The findings provide valuable real-world evidence regarding the safety profile of tirzepatide in routine clinical practice. Gastrointestinal symptoms and injection-site reactions were among the most frequently reported adverse events. Continuous pharmacovigilance and careful monitoring of patients receiving tirzepatide remain important to support its safe and effective clinical use.