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CC BY-NC-ND 4.0 · Drug Res (Stuttg)
DOI: 10.1055/a-2575-1530
Original Article

A Real-world Pharmacovigilance Study Of FDA Adverse Event Reporting System (FAERS) Events For Gender Of Voriconazole Drugs

Qiong Xu
1   Department of Hematology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, China
,
Hongxia Cheng
1   Department of Hematology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, China
,
Xu Sun
1   Department of Hematology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, China
,
Jing Zhao
1   Department of Hematology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, China
,
Yingying Chen
1   Department of Hematology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, China
,
Lingyu Ji
1   Department of Hematology, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, China
,
Yan Liang
2   Department of Orthopedics, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, China.
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Abstract

Purpose

To detect the gender variations in adverse events (AEs) of voriconazole, promote personalised medicine.

Methods

A normalized dataset from Q1 2004 to Q4 2022 from the US Food and Drug Administrationʼs Adverse Event Reporting System (FAERS) was analyses. The reporting odds ratio (ROR), proportional reporting ratio (PRR), and P value were used to examine data from the FAERS database to detect risk signals and quantify the presence and extent of gender variations in voriconazole adverse events.

Results

A total of 7670 cases (female/male (2785/4885)) of adverse reactions to voriconazole were analysed, and drug interaction (ROR 1.30 (1.10,1.54)), death and sudden death (ROR 1.31 (1.06,1.61)), actinic keratosis (ROR 1.98 (1.10,3.57)) were found to be significantly more frequent in male patients than in female patients.

Conclusion

We found that gender was a determinant in voriconazole-related AEs using FAERS. Our results require future validation due to the inherent limits of this open data source, but they also identify potential contributing elements for a customised side effect profiling.

Keywords

voriconazole - gender differences - real-world study - FAERS - adverse events

Supplementary Material



Publikationsverlauf

Eingereicht: 01. Januar 2025

Angenommen: 31. März 2025

Artikel online veröffentlicht:
28. April 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Georg Thieme Verlag
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 

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