Real-World Safety Concerns of Tirzepatide: A Retrospective Analysis of FAERS Data (2022-2025).
Almansour. Hadi A HA; Thaibah. Hilal A HA; Alfarhan. Moaddey M; Al-Qahtani. Saeed A SA; Khardali. Amani A AA; Alshammari. Thamir M TM
Key Findings
- Dosing errors increased 8‑fold from 2022 to 2024 with very strong safety signals
- Injection‑site reactions (pain, irritation) were among the top reported adverse events
- Gastro‑intestinal issues like nausea were frequent, especially in 2024
Practical Outcomes
- Make sure you follow the exact dosing schedule and technique—use a consistent injection site, double‑check the dose, and consider starting at a lower dose to reduce errors. Track any pain or nausea and report them to your clinician. Better education and clear guidelines can cut down the rising trend of adverse events.
Summary
The study looked at real‑world reports of tirzepatide side effects and found a big rise in dosing mistakes, plus common injection‑site pain and nausea. Most reports came from middle‑aged women in the U.S., and the errors got much more frequent over the last few years.
Abstract
<b>Background</b>: Tirzepatide (Mounjaro or Zepbound), a dual GLP-1/GIP receptor agonist, is approved for type 2 diabetes and weight management. Despite its efficacy, real-world safety data remain limited. This study analyzed post-marketing adverse events (AEs) associated with tirzepatide using the FDA Adverse Event Reporting System (FAERS) to identify emerging safety concerns. <b>Methods</b>: FAERS reports from 2022 to Q1 2025 were analyzed. Disproportionality analyses (proportional reporting ratio [PRR], reporting odds ratio [ROR], empirical Bayes geometric mean [EBGM], and information component [IC]) were performed to detect safety signals. Reports were stratified by year, demographics, and AE type, focusing on cases in which tirzepatide was the primary suspect. <b>Results</b>: Among 65,974 reports, the majority originated from the U.S. (96%), with middle-aged females (40-59 years; 67%) most frequently affected. Incorrect dose administration was the top AE, increasing 8-fold from 1248 (2022) to 9800 (2024), with strong risk signals (ROR 22.15, 95% CI (20.75-23.65), and ROR 23.43, 95% CI (22.82-24.05), respectively, and PRR 16.80, 95% CI (15.74-17.93), and PRR 17.62, 95% CI (17.16-18.09), respectively). Other common AEs included injection-site reactions (e.g., pain [5273 cases in 2024]), gastrointestinal issues (nausea [3602 in 2024]), and off-label use. Class-related AEs (e.g., decreased appetite and blood glucose fluctuations) were also reported. <b>Conclusions</b>: Tirzepatide is associated with significant dosing errors, injection-site reactions, and gastrointestinal AEs in real-world use. The rising trend in reports underscores the need for enhanced provider and patient education, clearer dosing guidelines, and proactive monitoring. Further research is warranted to explore causative factors and optimize risk mitigation strategies.
Study Information
pubmed
2025
2025-09-09T00:00:00.000Z
10.3390/healthcare13182259
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