ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Predictive Toxicology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1608657
A retrospective observational study on case reports of adverse drug reactions (ADR) to tirzepatide
Provisionally accepted
- 1Department of Pharmacy, The Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China
- 2Department of Pharmacy ,Lu 'an Hospital of Anhui Medical University, Lu 'an, China
- 3Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China
- 4Department of Pharmacy, Mengyin County People's Hospital, Linyi, China
- 5Department of Pharmacy, the Third People's Hospital, West Coast New Area, Qingdao, China
- 6The Affiliated Hospital of Qingdao University, Qingdao, China
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Background With the increasing clinical use of tirzepatide, its safety profile has garnered significant attention. This article systematically reviews case reports of tirzepatide-associated adverse drug reactions (ADRs) to summarize their characteristics.Method We searched PubMed, Web of Science, ScienceDirect, Wiley Online, and Embase databases for case reports on tirzepatide adverse events using the keywords: "tirzepatide", "adverse reaction", "adverse event", "side effect", "safety", "case report", "induced", "associated", and "related". Statistical analysis was performed on the identified cases..Results A total of 43 cases of tirzepatide ADR were identified from 37 articles.. Among these patients (24 female, 19 male; mean age 50.23 ± 17.24 years), 19 involved concomitant medications affecting multiple systems. ADR was reported in each dosage of tirzepatide, with the most occurring at 2.5-5 mg (16 cases), and primarily occurred within 1-6 months of initiation.Regarding rechallenge, 15 patients discontinued tirzepatide, three continued use, and one reduced the dose.. ADR involved seven gastrointestinal tract and endocrine systems, including liver and gallbladder, circulation, nerve, skin, and urinary. Notable manifestations included ketoacidosis, liver injury, hypotension, intestinal obstruction, and allergic reactions. Among them, ketoacidosis and common peroneal neuropathy causing foot sagging, acute appendicitis, lower limb venous thrombosis, gastric outlet obstruction, gastric emptying delay, and acute liver injury were not mentioned in the drug instructions.ADR correlation assessment was performed for 8 patients:4 cases of cardiovascular events and ketoacidosis were all evaluated as "probable" using the Naranjo scale,3 cases of liver injury were assessed by RUCAM (2 case as "possible", 1 cases as "probable"), 1 case did not specify the evaluation method, with the result being "highly probable". All 43 patients underwent ADR correlation re-evaluation: 32 cases (74.42%) were assessed as "probable", 11 cases (25.58%)were assessed as "possible".Conclusion Tirzepatide-associated ADRs most commonly occur within the first 6 months of treatment, primarily affecting the digestive, endocrine, liver, and gallbladder systems. Enhanced monitoring of liver and kidney function is warranted, especially in patients concurrently taking other potentially hepatotoxic or nephrotoxic medications.Additionally, intensified therapeutic drug monitoring is recommended for patients with cardiovascular disease, those requiring weight-based dosing adjustments, and those experiencing rapid weight loss.
Keywords: ADR, case report, systematic analysis, tirzepatide, adverse drug reactions
Received: 09 Apr 2025; Accepted: 16 Jun 2025.
Copyright: © 2025 Huang, Liu, Zhang, Wang, Liu and Zhao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Jun Zhao, The Affiliated Hospital of Qingdao University, Qingdao, China
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