To investigate and analyze the signal of semaglutide adverse events based on the FAERS database in the United States

LI Zhe; FU Yang

doi:10.20251/j.cnki.1003-3734.2026.05.016

Abstract：Objective:To explore the adverse event signals of semaglutide after its marketing and provide references for clinical safe medication.Methods:The reporting odds ratio(ROR),proportional reporting ratio(PRR),information component(IC),and multi-item gamma poisson shrinker(MGPS)methods were used to mine the adverse event data of semaglutide in the Adverse Event Reporting System(FAERS)of the US Food and Drug Administration(FDA)from the first quarter of 2004 to the second quarter of 2024.The adverse event signals of various injuries,poisonings,and operative complications were screened and comparatively analyzed.Results:A total of 17947720 background patients(with 53352754 adverse event occurrences)and 28747 patients in the target drug group(with 82931 adverse event occurrences)were included.A total of 430 positive signals of semaglutide were identified,involving 27 system organ classes(SOCs),mainly concentrated in gastrointestinal system diseases,general disorders and administration site reactions,various injuries,poisonings,and operative complications,etc.Among the preferred terms(PTs)related to various injuries,poisonings,and operative complications,the top 5 in frequency ranking included off-label use,product use in unapproved indications,etc.;the top 5 in intensity ranking included failure to perform drug dose titration,product communication issues,etc.Conclusion:There are multiple potential risks in the clinical use of semaglutide,especially issues related to medication norms and products.Clinicians should standardize medication use and closely monitor adverse reactions,and pharmaceutical manufacturers and regulatory authorities need to strengthen management to ensure the safety of patients'medication.