Mining adverse event signal of zanubrutinib based on the American FAERS database
WANG Na
Abstract：Objective:To explore adverse drug reaction(ADR)signals of zanubrutinib,so as to provide reference for medication safety in the clinic.Methods:Reports of zanubrutinib isrimary suspect drug-related ADR were collected from the American food and drug administration(FDA)adverse event reporting system(FAERS)database from Janu-ary 1,2019 to September 30,2024.Reporting odds ratio(ROR)method and medicines and proportional reportingratio(PRR)were used for data mining.The preferred system organ classification(SOC)and preferred terminology(PT)in the ICH Medical Dictionary for Regulatory Activities(MedDRA)were used to describe,classify and analyze ADR.Re-sults:A total of 1 472 ADR reports related to zanubrutinib were retrieved.This signal mining involves 24 kind of SOC,which were general disorders and administration site conditions/injury,poisoning and procedural complications,skin and subcutaneous tissue disorders.Conclusion:Before the application of zanubrutinib,a clinical medication assessment must be conducted,and during the treatment period,special attention should be paid to the risks of bleeding,hematological system,second primary malignancies,and infections in patients to ensure the safety of the treatment.
Keywords：zanubrutinibadverse event reporting systemadverse drug reactiondata mining
Publication Date：2025-10-10
Online Publishing Date：2025-10-29(First online date of this platform, not the publication date of the document)
Pages：6( 733-738 )