Assessing the Risk of Genital Infections and Fournier's Gangrene in Patients Taking SGLT2 Inhibitors: Insights from the FAERS Database
Document Type
Poster Presentation
Publication Date
4-17-2026
Keywords
fsc2026
Abstract
Background: Sodium-glucose co-transporter-2 (SGLT2) inhibitors are widely prescribed for type 2 diabetes mellitus, heart failure, and chronic kidney disease. While highly effective, their mechanism of increasing urinary glucose excretion elevates the risk of genitourinary adverse events. These include genital fungal infections and Fournier's gangrene, a rare but life-threatening necrotizing fasciitis that prompted an FDA warning in 2018.
Objective: This study aimed to determine which SGLT2 inhibitor (canagliflozin, dapagliflozin, or empagliflozin) presents the greatest risk for developing genital fungal infections and Fournier's gangrene, and to evaluate whether age and gender serve as confounding variables.
Methods: A retrospective pharmacovigilance analysis was conducted using the FDA Adverse Event Reporting System (FAERS) database. Data spanning from 2014 to 2024 were extracted for patients prescribed canagliflozin, dapagliflozin, and empagliflozin. The analysis evaluated the yearly and geographic distribution of adverse events, alongside clinical outcomes, disease severity, and demographic differences.
Results: The FAERS data revealed distinct variations in the frequency of genital fungal infections and Fournier's gangrene across the three SGLT2 inhibitors. The highest volume of reported adverse event cases for these medications occurred during the year 2019. Furthermore, the analysis illuminated specific demographic patterns, indicating that patient age and gender influence both the susceptibility to and severity of these genitourinary complications.
Conclusion: SGLT2 inhibitors carry varying risks for severe genitourinary infections depending on the specific medication and patient demographics. These findings emphasize the critical need for personalized risk assessment and vigilant clinical monitoring when prescribing these agents.
Publication Information
Anderson, Callahan; Gainer, Harley; and Bhatt, Priyanka, "Assessing the Risk of Genital Infections and Fournier's Gangrene in Patients Taking SGLT2 Inhibitors: Insights from the FAERS Database" (2026). Fisher Showcase 2026. Paper 37.
https://fisherpub.sjf.edu/fsc2026/37
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Comments
Poster presented at the 2026 Fisher Showcase, St. John Fisher University, April 17, 2026.