Chinese Journal of Pharmacovigilance ›› 2025, Vol. 22 ›› Issue (3): 305-312.
DOI: 10.19803/j.1672-8629.20240753

• Orginal Article • Previous Articles     Next Articles

Adverse Event Signals of Liraglutide and Semaglutide Based on the FAERS Database

ZHONG Ling1, ZENG Huiyan2, YUAN Xin1, WANG Yingyan1,*   

  1. 1Department of Pharmacy, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou Guangdong 510120, China;
    2Department of Endocrinology, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou Guangdong 510120, China
  • Received:2024-09-26 Online:2025-03-15 Published:2025-03-17

Abstract: Objective To mine and compare signals of post-marketing adverse events of liraglutide and semaglutide in order to provide references for safe and rational use. Methods Data on adverse events reported by the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) between January 1, 2010 and March 31, 2024 was mined using the reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, information component (IC) method, and the muti-item gamma poisson shrinker (MGPS) method. Positive signals and tumor related signals were screened out and compared. Results 175 positive signals related to liraglutide were mined, involving 20 systems organs class (SOC), compared with 231 for semaglutide, involving 21 SOC. The adverse events manifested themselves as gastrointestinal disorders, metabolism and nutrition disorders. In terms of tumors, thyroid and pancreatic related tumors were dominating and onset of symptoms in most of the cases was after 360 days. Liraglutide was more significantly correlated with such adverse events as thyroid tumors, pancreatic tumors, and pancreatitis while semaglutide was likely to cause adverse events related to eyes and the skin. Conclusion Liraglutide and semaglutide can cause similar adverse drug reactions, so clinicians are advised to opt for personalized medications while warnings about the possibility of pancreatic tumors should be given in related instructions.

Key words: Liraglutide, Semaglutide, FAERS Databases, Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), Muti-Item Gamma Poisson Shrinker (MGPS), Pancreatic Tumors, Adverse Drug Events

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