Signal mining and analysis of adverse drug events of raltegravir and dolutegravir based on the FAERS database

GU Jia-hui; ZHAO Jian-qun; CHEN Qing-yu; CAO Yan-li; MA Yin-ling

doi:10.20251/j.cnki.1003-3734.2026.11.013

Abstract：Objective:To mine the adverse drug event(ADE)signals of raltegravir and dolutegravir based on the FDA adverse event reporting system(FAERS)database,and provide references for clinical medication safety and rational drug selection.Methods:All ADE reports of raltegravir from the fourth quarter of 2007 to the fourth quarter of 2024 and dolutegravir from the third quarter of 2013 to the fourth quarter of 2024 in the FAERS database were mined using reporting odds ratio(ROR)and proportional report ratio(PRR).Results:After excluding all kinds of injuries,poisoning,and operation complications,as well as other unrelated signals such as all kinds of operations and medical operations,product problems and social problems,there were 4 136 ADE reports related to raltegravir,288 effective signals were obtained,and the signals involved 23 system organs;there were 2 119 cases of dolutegravir-related ADE reports,165 effective signals were mined,and 22 system organs were involved.The related ADE signals with significant differences between raltegravir and dolutegravir were mainly concentrated in nervous system disorders,psychiatric disorders,infections and infestations,blood and lymphatic system diseases,pregnancy,puerperium and perinatal conditions,congenital,familial and genetic diseases,and eye diseases,etc.Dolutegravir had a higher risk of ADEs in nervous system disorders and psychiatric disorders,while raltegravir had a higher risk in other disease-related ADEs.Conclusion:The study found that there is a significant difference in the risk of adverse events between raltegravir and dolutegravir in the treatment of acquired immunodeficiency syndrome,which can provide references for individualized clinical treatment.