Although well tolerated, there are known adverse effects with SGLT2 inhibitors that require clinical monitoring, such as genital mycotic infections, diabetic ketoacidosis, volume depletion particularly in the setting of concomitant diuretic use, and lower limb amputations with canagliflozin.
These data suggest that the goal to use SGLT2 inhibitors for their vasculo- and renoprotective actions may be problematic, as those most likely to benefit may also have the highest risk for DKA.
More DKA events were observed during off-label use of SGLT2 inhibitors in Sentinel than would be expected based on sotagliflozin clinical trials (SIR = 1.83; 95% CI, 1.45-2.28).
Adverse events including diabetic ketoacidosis in post-bariatric patients on sodium-glucose co-transporter 2 (SGLT2) inhibitors or inadequate insulin have been reported in patient's with both type 1 and type 2 diabetes.