{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T04:38:49Z","timestamp":1792471129201,"version":"4.5.0"},"reference-count":23,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T00:00:00Z","timestamp":1783900800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T00:00:00Z","timestamp":1783900800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Tirzepatide, a first\u2010in\u2010class dual GIP\/GLP\u20101 receptor agonist, was approved by the FDA for type 2 diabetes mellitus (2022) and chronic weight management (2023). Despite superior efficacy in trials, its real\u2010world safety profile remains incompletely characterised. This study aimed to characterise tirzepatide's post\u2010marketing safety signals using the FAERS database.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>FAERS reports listing tirzepatide as the primary suspected drug were extracted (Q2 2022\u2013Q4 2025). Disproportionality analysis used four algorithms (ROR, PRR, IC, EBGM). Adverse events were coded using MedDRA terminology. Time\u2010to\u2010onset and comparative analyses versus semaglutide were conducted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 123\u2009145 reports (251\u2009435 individual adverse events) were included. Females accounted for 62.30%, with a mean age of 53.7\u2009years. Major signals included medication errors, injection\u2010site reactions and gastrointestinal disorders. Novel unlabelled signals included eructation, hunger, food craving and starvation ketoacidosis. Compared with semaglutide, tirzepatide showed lower reporting odds of vomiting, constipation and decreased appetite. Among reports with valid onset data, median time to onset was 13\u2009days, with 67.1% occurring within 30\u2009days.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This FAERS study characterises tirzepatide safety signals in real\u2010world practice. Medication errors and injection\u2010site reactions were the strongest signals. Several novel signals warrant further investigation. Among reports with complete onset data, most adverse events were reported early after treatment initiation, suggesting the importance of closer monitoring during the first month of therapy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.71025","type":"journal-article","created":{"date-parts":[[2026,7,14]],"date-time":"2026-07-14T02:57:09Z","timestamp":1783997829000},"page":"8936-8945","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Safety Profile of Tirzepatide in Real\u2010World Clinical Practice: A Pharmacovigilance Study Using the\n                    <scp>FAERS<\/scp>\n                    Database"],"prefix":"10.1111","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4815-0158","authenticated-orcid":false,"given":"Xinghua","family":"Guo","sequence":"first","affiliation":[{"name":"Department of Pharmacy Maoming People's Hospital  Maoming China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiahua","family":"Zhang","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences Southern Medical University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qisen","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Maoming People's Hospital  Maoming China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiqiang","family":"Ye","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Maoming People's Hospital  Maoming China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shengyong","family":"Yuan","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Maoming People's Hospital  Maoming 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2024."},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.3390\/healthcare13182259"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.k3532"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1530\/EC-20-0547"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2021.109119"},{"key":"e_1_2_12_14_1","unstructured":"U.S. Food and Drug Administration \u201cMounjaro (Tirzepatide) Prescribing Information \u201d 2022."},{"key":"e_1_2_12_15_1","unstructured":"U.S. Food and Drug Administration \u201cZepbound (Tirzepatide) Prescribing Information \u201d 2023."},{"key":"e_1_2_12_16_1","unstructured":"U.S. Food and Drug Administration \u201cImmunogenicity Assessment for Therapeutic Protein Products \u201d 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