Table 4.

Adverse reactions to sodium glucose co-transporter 2 inhibitors9,11,12,1921

Adverse reactionFrequencyNotes
Genital mycotic infectionsCommon / very commonBoth male and female. Provide genital hygiene advice. Most initial cases can be treated with topical antifungals and won't recur. Consider reviewing therapy if recurrent infections.
Increased urinationCommonIncreased frequency and/or increased volume.
Urinary tract infectionsCommonIn recent large trials, any increase in risk was small and non-significant.
Volume depletion side effects (thirst, postural dizziness, hypotension and dehydration)Common/uncommon (varies with agent)Caution in frail/elderly. Consider measuring blood pressure in lying and standing position in those at risk of fall and those on diuretics
Diabetic ketoacidosisRare: <1/1,000 in SmPC (between 0 and 2 additional events per 1,000 person-years in RCTs); real life events may be higherInform and advise patients and healthcare professionals about how to prevent diagnose and treat DKA
AmputationUncommon: event rate <1/100 in SmPC (between 0 and 3 additional events per 1,000 person-years in RCTs);a real-life events may be lowerEncourage routine preventative foot care; regular foot checking
Advise patients to report wounds, discoloration or tender/painful feet
Consider stopping therapy if significant foot problems arise (such as infection or skin ulcers)
  • aExcess amputations were only seen in one study; subsequent studies with the same SGLT2 inhibitor and others have not confirmed a significant increase; any risk is likely to be very low. Necrotising fasciitis (Fournier's gangrene): post-marketing reports have been reported (six yellow card reports in >500,000 patient-years. Recent large trials have not shown any increase in risk. Patients should be advised to seek urgent medical attention if they experience fever/malaise along with pain, tenderness or redness in the genital or perineal area.22 DKA = diabetic ketoacidosis; SmPC = summary of product characteristics. Frequency: very common = ≥1/10; common = ≥1/100 to <1/10; uncommon = ≥1/1,000 to <1/100; rare = ≥1/10,000 to < 1/1,000.