Tirzepatide safety in type 2 diabetes: a disproportionality analysis of adverse events using the FDA FAERS database
This study evaluated adverse events reported with tirzepatide, a dual GIP/GLP-1 receptor agonist approved for type 2 diabetes and obesity, using real-world data from the FDA Adverse Event Reporting System. A disproportionality analysis was conducted on reports from May 2022 to the fourth quarter of...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Bioscientifica
2025-07-01
|
| Series: | Endocrine Connections |
| Subjects: | |
| Online Access: | https://ec.bioscientifica.com/view/journals/ec/14/7/EC-25-0205.xml |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849304157331128320 |
|---|---|
| author | Zhenpo Zhang Jiangxiong Li Jingping Zheng Yankun Liang Lin Ma Ling Su |
| author_facet | Zhenpo Zhang Jiangxiong Li Jingping Zheng Yankun Liang Lin Ma Ling Su |
| author_sort | Zhenpo Zhang |
| collection | DOAJ |
| description | This study evaluated adverse events reported with tirzepatide, a dual GIP/GLP-1 receptor agonist approved for type 2 diabetes and obesity, using real-world data from the FDA Adverse Event Reporting System. A disproportionality analysis was conducted on reports from May 2022 to the fourth quarter of 2024. Reports were deduplicated, normalized using standardized medical terminology, and analyzed using four disproportionality analysis algorithms. Significant signals required meeting all four methods’ criteria with at least three cases. Among 20,350 adverse event reports (68.0% female; median age 50.4 years), 105 significant adverse events were identified. Common events included gastrointestinal disorders (nausea and diarrhea) and injection-site reactions. The strongest signals were injection-site coldness and belching. Known risks such as pancreatitis (190 cases) and hypoglycemia (115 cases) were confirmed. Novel signals included upper respiratory infections and postmenopausal hemorrhage. The median onset time was 26 days, with 50% of events occurring within the first month. Older adults (65 years or older) experienced earlier onset (12 versus 31 days, significant difference). This analysis is consistent with known gastrointestinal and pancreatic risks of tirzepatide from prior clinical studies and identifies potential new safety concerns, underscoring the need for vigilant monitoring, particularly during initial treatment phases. |
| format | Article |
| id | doaj-art-fa3221a2ad1b4e858590e702793bdad9 |
| institution | Kabale University |
| issn | 2049-3614 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Bioscientifica |
| record_format | Article |
| series | Endocrine Connections |
| spelling | doaj-art-fa3221a2ad1b4e858590e702793bdad92025-08-20T03:55:48ZengBioscientificaEndocrine Connections2049-36142025-07-0114710.1530/EC-25-02051Tirzepatide safety in type 2 diabetes: a disproportionality analysis of adverse events using the FDA FAERS databaseZhenpo Zhang0Jiangxiong Li1Jingping Zheng2Yankun Liang3Lin Ma4Ling Su5College of Pharmacy, Jinan University, Guangzhou, Guangdong, ChinaZhuhai Jiuhuatong Biomedical Technology Co., Ltd, Zhuhai, Guangdong, ChinaCollege of Pharmacy, Jinan University, Guangzhou, Guangdong, ChinaCollege of Pharmacy, Jinan University, Guangzhou, Guangdong, ChinaSchool of Food Science and Engineering, South China University of Technology, Guangzhou, Guangdong, ChinaCollege of Pharmacy, Jinan University, Guangzhou, Guangdong, ChinaThis study evaluated adverse events reported with tirzepatide, a dual GIP/GLP-1 receptor agonist approved for type 2 diabetes and obesity, using real-world data from the FDA Adverse Event Reporting System. A disproportionality analysis was conducted on reports from May 2022 to the fourth quarter of 2024. Reports were deduplicated, normalized using standardized medical terminology, and analyzed using four disproportionality analysis algorithms. Significant signals required meeting all four methods’ criteria with at least three cases. Among 20,350 adverse event reports (68.0% female; median age 50.4 years), 105 significant adverse events were identified. Common events included gastrointestinal disorders (nausea and diarrhea) and injection-site reactions. The strongest signals were injection-site coldness and belching. Known risks such as pancreatitis (190 cases) and hypoglycemia (115 cases) were confirmed. Novel signals included upper respiratory infections and postmenopausal hemorrhage. The median onset time was 26 days, with 50% of events occurring within the first month. Older adults (65 years or older) experienced earlier onset (12 versus 31 days, significant difference). This analysis is consistent with known gastrointestinal and pancreatic risks of tirzepatide from prior clinical studies and identifies potential new safety concerns, underscoring the need for vigilant monitoring, particularly during initial treatment phases.https://ec.bioscientifica.com/view/journals/ec/14/7/EC-25-0205.xmltirzepatidetype 2 diabetespharmacovigilancefaers databaseadverse drug eventsreal-world evidence |
| spellingShingle | Zhenpo Zhang Jiangxiong Li Jingping Zheng Yankun Liang Lin Ma Ling Su Tirzepatide safety in type 2 diabetes: a disproportionality analysis of adverse events using the FDA FAERS database Endocrine Connections tirzepatide type 2 diabetes pharmacovigilance faers database adverse drug events real-world evidence |
| title | Tirzepatide safety in type 2 diabetes: a disproportionality analysis of adverse events using the FDA FAERS database |
| title_full | Tirzepatide safety in type 2 diabetes: a disproportionality analysis of adverse events using the FDA FAERS database |
| title_fullStr | Tirzepatide safety in type 2 diabetes: a disproportionality analysis of adverse events using the FDA FAERS database |
| title_full_unstemmed | Tirzepatide safety in type 2 diabetes: a disproportionality analysis of adverse events using the FDA FAERS database |
| title_short | Tirzepatide safety in type 2 diabetes: a disproportionality analysis of adverse events using the FDA FAERS database |
| title_sort | tirzepatide safety in type 2 diabetes a disproportionality analysis of adverse events using the fda faers database |
| topic | tirzepatide type 2 diabetes pharmacovigilance faers database adverse drug events real-world evidence |
| url | https://ec.bioscientifica.com/view/journals/ec/14/7/EC-25-0205.xml |
| work_keys_str_mv | AT zhenpozhang tirzepatidesafetyintype2diabetesadisproportionalityanalysisofadverseeventsusingthefdafaersdatabase AT jiangxiongli tirzepatidesafetyintype2diabetesadisproportionalityanalysisofadverseeventsusingthefdafaersdatabase AT jingpingzheng tirzepatidesafetyintype2diabetesadisproportionalityanalysisofadverseeventsusingthefdafaersdatabase AT yankunliang tirzepatidesafetyintype2diabetesadisproportionalityanalysisofadverseeventsusingthefdafaersdatabase AT linma tirzepatidesafetyintype2diabetesadisproportionalityanalysisofadverseeventsusingthefdafaersdatabase AT lingsu tirzepatidesafetyintype2diabetesadisproportionalityanalysisofadverseeventsusingthefdafaersdatabase |