Abstract： Objective To mine and evaluate the adverse drug event(ADE)signals of sorafenib and regorafenib,so as to provide reference for clinical medication.Methods ADE reports of sorafenib and regorafenib were retrieved in the OpenVigil 2.1 database up to the second quarter of 2022.The reporting odds ratio(ROR),proportional reporting ratio(PRR)and comprehensive standard method(MHRA)were used for signal mining to evaluate the characteristics of ADE signals.Results A total of 11 391 cases of sorafenib ADE and 4 941 cases of regorafenib ADE were reported.There were 929 ADE signals,including 579 for sorafenib and 350 for regorafenib.The ADE most frequently reported for sorafenib was diarrhea,with 1 363 cases(11.97％),and its strongest association was with vitamin K deficiency or antagonist Ⅱ-induced protein elevation(ROR=502.46,PRR=502.064).As for regorafenib,the most frequently reported ADE was fatigue,with 598 cases(12.1％),and its strongest association was with palmoplantar keratoderma(ROR=185.378,PRR=185.08).Sorafenib ADE signals involved 25 system organ classes(SOCs),while regorafenib ADE signals involved 22 SOCs.Two ADE signals were identified as unmentioned in the sorafenib package insert,and three were found unmentioned in the regorafenib package insert.Conclusion Sorafenib and regorafenib,as structurally similar anti-cancer drugs,have mostly overlapping ADE signals.New signals were found in terms of the number of reports,involved systems and organs,and association strength,suggesting that clinicians should pay attention to the related ADEs.The differences in the number of ADE signal reports and association strength between the two drugs can provide reference for their clinical use,and it is recommended to use them based on signal bias in clinical practice.