Analysis of Adverse Drug Events of Isavuconazole Based on Real-World Data

LIANG Yan; QIAO Lijuan; LU Jingli; HAO Jie; ZHANG Rui; JIA Mengmeng; DU Shuzhang

doi:10.3969/j.issn.1004-437X.2026.09.003

Abstract：Objective To evaluate the adverse drug event(ADE)of isavuconazole(ISA)based on America Food and Drug Administration Adverse Event Reporting System(FAERS)database,so as to provide references for clinical medication safety.Methods ADE reports of ISA from the third quarter of 2014 to the second quarter of 2022 were collected,and ADE signals were analyzed using proportional reporting ratio(PRR)method and reporting odds ratio(ROR)method in the proportional imbalance method.Results A total of 873 cases related to ISA were extracted,and 394 of them listed ISA as the primary suspect drug.The male was more than the female,and median age was 65 years old.A total of 37 valid signals were ultimately identified and mapped to 11 system organ classifications(SOCs),while 30 signals were not mentioned in the ISA package insert.The SOC of ISA ADE signals mainly involved general disorders and administration site conditions,infections and infestations,blood and lymphatic system disorders.While,the ADE signals mainly involved aspergillus infection,leukemia recurrent,systemic candida,mucormycosis et al.Conclusion In the clinical application of ISA,in addition to ADE mentioned in the drug instructions,we should also monitor the patient's liver function,heart rhythm,electrolytes,et al.Close attention should be paid to the general disorders,infections and infestations,blood and lymphatic system disorders,especially during off-label use.Meanwhile,we should be alert for the occurrence of ADE signals not mentioned in the drug instructions,take preventive and treatment measures in time to lower clinical drug-induced risks.