The sodium-glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin is approved to treat type 2 diabetes mellitus (T2DM) in adults.

This analysis was conducted on safety data pooled from seven randomized, double-blind phase 3 studies using ertugliflozin 5 mg or 15 mg versus placebo or an active comparator.

Ertugliflozin was associated with thirst, increased urination, volume depletion in some subgroups [those with impaired renal function (estimated glomerular filtration rate < 60 ml/min/1.73 m2), or who were at least 65 years of age, or who were taking diuretics, and those with genital mycotic infection (in both females and males)]; ertugliflozin was not associated with urinary tract infection, fracture, or hypoglycemia, and there were no cases of Fournier’s gangrene. Events of ketoacidosis were reported.

There were small numbers of patients with lower limb amputation; an association with ertugliflozin remains uncertain.

Ertugliflozin was generally well tolerated in a large general population of patients with T2DM taking a range of background diabetes medications including insulin and insulin secretagogs and had a safety profile generally consistent with other SGLT2 inhibitors.