ArticleJournal of endocrinological investigation2026
Amputation and gangrene associated with SGLT2 inhibitors: pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database.
Article in Journal of endocrinological investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- Comparative Analysis of Potential Side Effects of Targeted Oral Hypoglycemic Agents Using Spontaneous Adverse Event Reports and Social Media Data.Pharmacoepidemiology and drug safety · 2026Article
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1 author.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundSodium-glucose co-transporter-2 (SGLT2) inhibitors are widely prescribed to diabetic patients for their cardiorenal benefits. However, concerns over adverse events—specifically amputation risk and gangrene—have risen in recent years. This study aimed to describe the frequency and severity of these events in relation to SGLT2 inhibitor use, using the U.S. FDA Adverse Event Reporting System (FAERS).
methodsOpenVigil 2.1 was used to extract safety reports submitted to FAERS from 2003 Q4 to 2024 Q4. Amputation and gangrene events linked to SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin) were identified and compared to other drugs. Reporting odds ratios (RORs) were calculated.
resultsA total of 3,540 adverse event reports were identified: 2,128 for canagliflozin, 361 for dapagliflozin, 1,049 for empagliflozin, and 2 for ertugliflozin. Canagliflozin was strongly associated with toe amputation (ROR = 635.6; 95%CI: 566.7–712.1), foot amputation (ROR = 201.8; 95%CI: 174.3–233.7), and Fournier’s gangrene (ROR = 117.5; 95%CI: 100.0–138.0). Empagliflozin was linked with Fournier’s gangrene (ROR = 565.2; 95%CI: 525.3–608.2) and toe amputation (ROR = 21.2; 95%CI: 17.6–25.6). Dapagliflozin showed weaker signals; ertugliflozin had minimal data.
conclusionToe amputation and Fournier’s gangrene were most reported with canagliflozin and empagliflozin, reinforcing prior safety concerns and the need for monitoring.
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