Real-world study of isavuconazole adverse events based on pharmacovigilance spontaneous reporting systems

BACKGROUND: Isavuconazole is a novel second-generation triazole antifungal agent.We conducted a retrospective investigation to analyze the occurrence of adverse events (AEs) associated with isavuconazole in real-world clinical use by data-mining self-reporting databases, aiming to provide comprehensive data for its safe and effective clinical application. RESEARCH DESIGN AND METHODS: All data obtained from the VigiBase, the EudraVigilance and the FAERS database. In the FAERS database, data mining algorithms, including reporting odds ratio (ROR) and proportional reporting ratio (PRR), were utilized to detect adverse event (AE) signals. RESULTS: A total of 4,105 AE reports related to isavuconazole were retrieved from these databases. The highest proportion of AE reports was observed in individuals aged between 18-64 years old. The general disorders and administration site conditions system organ class accounted for the largest number of reported cases. The system organ classes with most signals and reports included general disorders and administration site conditions, blood and lymphatic system disorders as well as investigations related to hepatobiliary disorders. Notably high ROR and PRR values were observed for AE signals associated with hepatobiliary disorders. CONCLUSION: Isavuconazole has fewer interactions and less liver, kidney and cardiac toxicity than other triazole antibiotics. The identification of novel AEs necessitates meticulous attention and further investigation and analysis.