Drug-Related Candidiasis Risk Profiling: A Real-World Pharmacovigilance Study Leveraging the FDA Adverse Event Reporting System (FAERS).

Background: Although several drugs have been linked to candidiasis, the risk profiles of this condition remain unclear for most therapeutic agents.

Objectives: Aiming to provide critical references for developing clinically actionable risk stratification frameworks, this study investigated risk factors associated with the occurrence and mortality of drug-related candidiasis using real-world data.

Methods: Reporting odds ratios (ROR) were calculated to evaluate the signal strength of candidiasis across drugs reported in the FDA Adverse Event Reporting System (FAERS; Q1 2004 to Q3 2024). Multidimensional regression analyses were conducted to identify key risk factors for drug-related candidiasis.

Results: This pharmacovigilance study identified 259 drugs associated with candidiasis through disproportionality analysis. After exclusion through univariate regression and LASSO regression, the final multivariable logistic regression analysis included 1526 candidiasis cases and 200,173 non-cases (control), revealing that female gender, older age (≥ 65 years) and 32 specific drugs were independent risk factors for drug-related candidiasis. These drugs primarily included monoclonal antibodies (6/32), antibiotics (4/32), glucocorticoids (4/32) and chemotherapy agents (4/32). Affected patients exhibited distinct clinical outcomes, with mortality-related regression analysis further revealing a significant association for these drug classes. Notably, five drugs, cytarabine, etoposide, prednisone, prednisolone and dexamethasone, exhibited dual associations as both independent susceptibility factors and mortality risk factors in drug-candidiasis progression. Our temporal analysis suggested enhanced clinical vigilance during the first month following the administration of these drugs to facilitate early infection detection.

Conclusion: The findings offer critical references for developing risk stratification frameworks in clinical practice, and establish priority targets for future research into the pathogenesis and mortality mechanisms of this infection.