Pharmacovigilance analysis of posaconazole in the treatment of systemic fungal infection : assessing safety profiles and adverse event patterns in real-world data from FAERS (2018-2022)

Abstract

This study uses FDA Adverse Event Reporting System (FAERS) data to analyse Posaconazole, a second-generation antifungal drug. The goal is to gain insights into Posaconazole's safety profile by analysing clinical adverse occurrences. Data spanning 2018 to 2022 were extracted from FAERS, cleaned, and merged with the MedDRA terminology for adverse event categorization. Using the Reporting Odds Ratio (ROR), the study focuses on comparing the relative odds of specific adverse events associated with Posaconazole versus other drugs. Potential associations between Posaconazole and adverse events were identified based on ROR values and 95% confidence intervals. Among the 32,954 reports analyzed, 2,359 distinct adverse events and 727 signals were identified. Notable adverse events with high ROR values included Pseudoaldosteronism, CARD9 deficiency, Microsporum infection, Left-atrial hypertrophy, Acquired apparent mineralocorticoid excess, Donor leukocyte infusion, and SARS-CoV-2 RNA. By using real-world FAERS data, this study provides useful understanding of Posaconazole's safety profile, can help healthcare professionals make informed decisions about its use, and advances pharmacovigilance.