Severe cutaneous adverse reactions associated with antifungal agents: a pharmacovigilance analysis based on the FDA Adverse Event Reporting System (FAERS) database.

Background: The aim of this study was to explore the risk of severe cutaneous adverse reactions (SCARs) caused by different antifungal drugs in the real world.

Methods: We extracted the data from the FDA Adverse Event Reporting System (FAERS) from January 2004 to December 2022 and performed disproportionality analyses to characterize the signal differences of antifungal agents-related SCARs.

Results: A total of 952 antifungals-related SCARs were identified. Antifungal drugs-related SCARs were more common in the 18-64 age group than other groups, and five agents were detected significant SCAR signals in this age group. Among these antifungals, fluconazole had the strongest associations with the SCARs, and showed significant SCAR signals at all age stages. Six antifungals showed a significant association with SCARs under disproportionality. The reporting odds ratios (RORs) and the 95% confidence intervals (95% CI) for six antifungals were as follows: fluconazole (9.50, 8.62-10.47), caspofungin (8.92, 7.29-10.91), itraconazole (3.48, 2.78-4.35), amphotericin B (2.73, 2.20-3.39), micafungin (2.62, 1.85-3.71) and voriconazole (2.50, 2.12-2.94).

Conclusions: The data mining of FAERS demonstrated that antifungal drugs were significantly associated with SCARs, which reminded clinicians to continue monitoring patients who are at risk of developing SCARs with the use of these drugs.