Signal mining and analysis of adverse drug events of tirzepatide
- VernacularTitle:替尔泊肽不良事件信号挖掘与分析
- Author:
Zeyu XIE
1
;
Zhuoru LIANG
1
;
Guimei ZHENG
1
;
Weiling CAO
1
;
Jisheng CHEN
2
Author Information
1. Dept. of Pharmacy，Shenzhen Luohu People’s Hospital，Guangdong Shenzhen 518000，China
2. Key Specialty of Clinical Pharmacy，the First Affiliated Hospital of Guangdong Pharmaceutical University，Guangzhou 510080，China
- Publication Type:Journal Article
- Keywords:
tirzepatide;
FDA Adverse Event Reporting System;
adverse drug event;
signal mining
- From:
China Pharmacy
2025;36(8):956-960
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To identify and analyze adverse drug event （ADE） signals associated with tirzepatide based on the FDA Adverse Event Reporting System （FAERS） database， providing a reference for clinical medication safety. METHODS ADE reports from January 1， 2022， to June 30， 2024， with tirzepatide as the primary suspected drug， were extracted from the FAERS database. Medical Dictionary for Regulatory Activities was used to systematically categorize the selected system organ class （SOC） and preferred term of ADE. Signal mining and analysis were performed using the reporting odds ratio method and the proportional reporting ratio method. RESULTS A total of 39 229 ADE reports related to tirzepatide were obtained， including 3 934 severe ADE reports （10.03%）. The majority of severe ADE reports were related to hospitalization or prolonged hospitalization （3.82%）， involving 131 positive ADE signals. Among the reports with documented patient gender and age， 26 195 were female （66.77%）， 7 869 were male （20.06%）， and the majority of patients were aged 18-64 years （54.26%）. The top three most frequently reported ADE were injection site pain， nausea， and injection site hemorrhage. Strong ADE signals not mentioned in the tirzepatide instruction included injection site coldness， starvation ketoacidosis， injection site hemorrhage， hunger， elevated adrenaline， injection site skin cracking， binge eating， skin laxity， intestinal sepsis， lack of satiety， and dysesthesia. Subgroup analysis for patient’s gender and age showed differences in the proportion of ADE reports across different SOC. Male patients or those aged≥65 years had a higher risk of gastrointestinal system disorders compared to female patients or those aged ＜65 years. CONCLUSIONS In clinical use of tirzepatide， in addition to monitoring ADE listed in the instruction， attention should also be paid to ADE not mentioned in the instruction， such as injection site coldness， starvation ketoacidosis， injection site hemorrhage， elevated adrenaline， and intestinal sepsis， to ensure patient safety.
