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Safety of SGLT2 inhibitors for patients with type 2 diabetes: where are we now?

André J Scheen1,2

  • 1Division of Diabetes, Nutrition and Metabolic Disorders, CHU Liège, Liège, Belgium.

Expert Opinion on Drug Safety
|April 25, 2026
PubMed
Abstract

Insights

Sodium-glucose cotransporter 2 inhibitors (SGLT2is) show a reassuring safety profile, with confirmed risks of genital infections but not urinary tract infections. Initial fears of severe events like fractures and amputations were not substantiated in further studies.

Area of Science:

  • Pharmacology
  • Cardiology
  • Endocrinology

Background:

  • Sodium-glucose cotransporter 2 inhibitors (SGLT2is) are increasingly used for type 2 diabetes (T2D).
  • Concerns regarding adverse events may contribute to their underutilization.
  • An updated safety assessment is crucial for clinical practice.

Purpose of the Study:

  • To provide a comprehensive review of the safety and tolerability of SGLT2is.
  • To address fears surrounding adverse events associated with SGLT2is.

Main Methods:

  • Extensive literature search including randomized controlled trials, observational cohort studies, and pharmacovigilance reports.
  • Focus on safety data in patients with type 2 diabetes (T2D), including those with comorbidities or at-risk conditions.

Main Results:

  • Confirmed increased risk of genital infections; urinary tract infection risk not confirmed.
  • Euglycemic diabetic ketoacidosis and volume depletion remain rare events.
  • Severe adverse events like fractures, amputations, perineal infections, and acute renal injury were not confirmed in subsequent studies.

Conclusions:

  • The overall safety profile of SGLT2is is reassuring, even in at-risk populations.
  • Caution is advised in patients with severe comorbidities, the very old, or frail individuals due to limited data.
Keywords:
Adverse eventsSGLT2 inhibitorsfrailty populationssafetytolerabilitytype 2 diabetes

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