Pharmacovigilance analysis of the association between SGLT-2 inhibitors and diabetic foot infections using the FAERS database: An observational study
Authors' conclusion
A strong, agent-specific signal links canagliflozin to DFI. Clinicians should prioritise foot surveillance and consider safer SGLT-2 inhibitor alternatives in high-risk patients.
Study context
- Population
- FAERS reports 2004 Q1–2024 Q2; 62,098 records with an SGLT2i as primary suspect drugreports
- Participants
- 8,312,293 reports
- Exposure
- Individual SGLT2i vs other reports in FAERS
- Outcome
- Disproportionality (ROR, Proportional Reporting Ratio (PRR), Information Component (IC), EBGM) for diabetic foot infection (DFI) with individual SGLT2i
Methodological detailsFAERS database, 2004 Q1–2024 Q2, primary suspect events only
- FAERS database
- 2004 Q1–2024 Q2
- Primary suspect events only
Main finding
As reported in the abstract
Disproportionality signal for DFI (ROR) by SGLT-2 inhibitor
Canagliflozin
162.84
Reporting Odds Ratio (ROR) · 95% CI 134.14–197.68
Empagliflozin
0.56
ROR
Dapagliflozin
2.19
ROR
- Class-level ROR (SGLT-2 inhibitors)
- 55.51 (45.18-68.21)
- Diabetic foot infection (DFI) cases implicating an SGLT-2 inhibitor, among 8 312 293 reports
- 565
Observational data: associations, not effects.
Further findings
DFI ROR by exposure duration (SGLT2i)
- ROR, exposure ≤30 days
- 11.25 (95% CI 8.14-15.56)
- ROR, exposure >365 days
- 48.77 (95% CI 39.88-59.64)
- Empirical Bayes Geometric Mean (EBGM) and its 95%CI progressively intensified with longer exposure
Original publication
Pharmacovigilance analysis of the association between SGLT-2 inhibitors and diabetic foot infections using the FAERS database: An observational study. Diabetes Res Clin Pract. Published 21 January 2026. doi:10.
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