Adverse drug reaction signals of statin-induced male sexual dysfunction:Mining and analysis based on the FDA Adverse Event Reporting System

GAO Wen; SUN Ling; AN Xiaotong; DU Wei; CHEN Bo; WANG Xitao; PANG Kun

doi:10.13263/j.cnki.nja.2026.02.009

Abstract：Objective To mine and analyze the adverse drug reaction(ADR)signals of statin-induced male sexual dys-function based on the database of the FDA Adverse Event Reporting System(FAERS).Methods We searched the FAERS da-tabase for the case reports published from the first quarter of 2004 to the fourth quarter of 2023,in which statins were shown as the primary suspected drugs for sexual dysfunction ADRs in male patients,and subjected the reports to standardized processing according to the WHO Adverse Reaction Terminology.We detected the ADR signals using the reporting odds ratio(ROR),pro-portional reporting ratio(PRR),and Bayesian confidence propagation neural network(BCPNN).Results A total of 2 408 adverse event reports of male sexual dysfunction associated with statins as the primary suspected drug were extracted from the FAERS database,involving 2 173 patients(some patients reported multiple adverse events).The largest proportion of the pa-tients(47.22％[1 026/2 173])were aged 18-65 years old,primarily from the United States(n=897,41.28％),the lar-gest number of cases reported in 2010(n=183,8.42％),and atorvastatin ranking the first for intervention(n=990,41.11％),followed by rosuvastatin(n=639,26.54％)and simvastatin(n=502,20.85％).Totally,28 high-risk ADR signals for male sexual dysfunction were identified,among which,hypoesthesia was found related to 7 statins(atorvastatin,rosuvastatin,simvastatin,pravastatin,fluvastatin,lovastatin,and pitavastatin),and ED associated with 6(atorvastatin,rosuvastatin,simv-astatin,pravastatin,ezetimibe and lovastatin).Conclusion Sufficient medication evaluation is necessitated prior to clinical ap-plication of statins,especially for patients aged 18-65 years,with caution against the development of male sexual dysfunction within 30 days of administration.Clinicians should pay attention to ADR signals beyond those listed in the drug package inserts to ensure the safety of medication.