Objective To provide a reference for the safe use of alectinib in the clinic.Methods Alectinib-related adverse drug event(ADE)reports from the first quarter of 2014 to the third quarter of 2022 in the Food and Drug Administration Adverse Event Reporting System(FAERS)were retrieved,and the ADE signals were mined by the reported odds ratio(ROR)method and proportional reporting ratio(PRR)method.Results A total of 2 236 effective ADE reports were obtained,with alectinib as the primary suspected drug,with a male-to-female ratio of approximately 1∶1.27.A total of 118 ADE signals of alectinib were obtained,with the most commonly reported adverse drug reactions(ADRs)being death,fatigue,constipation,rash,etc.The ADRs with high correlation mainly included the presence of acanthocyte,spike cell anemia,hemolysis,central nervous system metastasis,intracranial tumor bleeding,etc.ADR not listed in the drug instructions included the presence of acanthocyte,spike cell anemia,intracranial tumor hemorrhage,protein reduction,pleural effusion,fatigue,pericardial effusion,COVID-19 infection,etc.Conclusion The common ADRs of alectinib are basically consistent with the drug instructions,but attention should be paid to ADRs not listed in the drug instructions,such as red blood cell membrane disease,fatigue,pleural effusion,etc,to ensure the safety and effectiveness of medication in the clinic.
alectinibFAERSadverse drug reactionspharmacovigilancedata mining
万方数据
维普
