Mining and analysis of ADR signals of six representative TKI drugs based on FAERS

WU Qian; LIU Lihui; WANG Ting; NIE Jing; WU Jiyong

doi:10.3969/j.issn.1002-266X.2025.01.013

Abstract：Objective To mine and analyze the adverse drug reaction(ADR)signals associated with representative tyrosine kinase inhibitors(TKIs)drugs in the US Food and Drug Administration Adverse Event Reporting System(FAERS),with the aim of providing insights for rational drug use in the clinical practice.Methods ADR reports of six TKI(imatinib,gefitinib,dasatinib,sunitinib,sorafenib and rivoceranib)from March 2004 to September 2022 were col-lected by using FAERS and the data platform of OpenVigil 2.1.Reporting odds ratio(ROR)and proportional reporting ra-tio(PRR)were used to analyze the ADR signals of these six representative TKI drugs,and we ranked them according to their frequency and signal intensity.Results A total of 105,052 ADR reports were retrieved from six representative TKIs,with sunitinib accounting for the highest number of reports(38,498).In terms of frequency,ADRs associated with the six TKIs predominantly affected the skin and subcutaneous tissues,as well as the gastrointestinal system.Among respi-ratory,thoracic,and mediastinal diseases,imatinib ranked 7th in the occurrence of pleural effusion.Imatinib was linked to risk signals related to abnormal genetic analysis,including chromosomal and cellular alterations.Gefitinib showed risk signals such as elevated mitochondrial aspartate aminotransferase levels.Dasatinib might cause chylothorax,sunitinib might result in eyelash discoloration,and sorafenib might lead to palmoplantar keratoderma.Conclusions The ADRs and affected systems indicated by the risk signals of the six representative TKIs are consistent with those described in the package inserts.However,risk signals such as pleural effusion caused by imatinib and ocular ADRs caused by sunitinib are not mentioned in the package inserts.