Data analysis of isavuconazole adverse events based on FAERS database and case reports
Xu Hui-yu
Qi Rui-zhe
Yan Yao-dong
Lu Shu
Fan Li-ping
Abstract：Objective To provide a reference for the safe use of isaconazole through the analysis of adverse events in FAERS database and case reports of adverse reactions at home and abroad. Methods SAS 9.4 software was used to mine and analyze the adverse event signals of isavuconazole from the first quarter of 2015 to the second quarter of 2024 by using the ROR method and BCPNN method. Endnote 20.0 software was used for case report screening. Results A total of 788 patients with isavuconazole as the main suspected drug were obtained,2292 adverse events were reported,and 37 effective positive signals were obtained. Changes in blood drug concentration,gastrointestinal tract,hepatobiliary system and drug interactions were screened out. Other adverse events such as intestinal perforation and prolongation of the QT interval on the electrocardiogram etc. not mentioned in the instructions were found. A total of 7 cases were collected in the case reports,and the reported adverse reactions included hypomagnesemia,liver injury,liver failure,pancytopenia,edema and delirium. Conclusion The adverse events mined in the FAERS database and the adverse reactions mentioned in case reports are basically in consistent with the instructions,and the potential adverse events not mentioned in the label can be important hints for clinical application.
Keywords：IsavuconazoleFAERSAdverse eventData analysisCase report
Publication Date：2024-12-25
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 852-857 )