FAERS Database Analysis of Arrhythmia Risk for Nine Systemic Antifungal Drugs

42,393 adverse event reports from the US FDA Adverse Event Reporting System (FAERS) were analyzed for arrhythmogenic toxicity signals associated with nine systemic antifungal drugs. The study, authored by Xiaohu Yang and last updated in May 2026, used four disproportionality analysis algorithms (ROR, PRR, MGPS, BCPNN) to calculate risk signals. Itraconazole, fluconazole, and posaconazole showed stronger arrhythmogenic risks, while micafungin, flucytosine, and isavuconazole showed negative signals.

Use Cases

• Compare arrhythmia risk signals between nine antifungal drugs based on disproportionality analysis results.
• Validate pharmacovigilance algorithms (ROR, PRR, MGPS, BCPNN) using a real-world adverse event reporting database.
• Identify high-risk antifungal agents for specific arrhythmia types (e.g., Torsade de pointes/QT prolongation) based on reported ROR values.
• Support clinical decision-making for personalized antifungal drug selection based on patient cardiac risk profiles.

Strengths

• Analysis is based on 42,393 real-world adverse event reports from the FAERS database.
• Employs four established disproportionality analysis methods (ROR, PRR, MGPS, BCPNN) for signal detection.
• Provides specific risk metrics, such as an ROR of 14.55 for Fluconazole in 'Torsade de pointes/QT prolongation'.

Limitations

• Row count and column-level documentation for the underlying data are unknown, limiting suitability assessment.
• The dataset is very small (52.0 KB), suggesting it may contain summary statistics rather than the raw case-level data.
• Description metadata is limited; actual data structure and quality require manual inspection after download.

Provenance

Source

US Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Collection Method

Disproportionality analysis of reported adverse events using Standardized MedDRA Queries (SMQs).

Freshness

Last updated 2026-05-26 08:11:05; freshness should be verified.

Geography

Likely United States, inferred from the use of the US FAERS database.