Adverse reaction | Frequency | Notes |
---|---|---|
Genital mycotic infections | Common / very common | Both 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 urination | Common | Increased frequency and/or increased volume. |
Urinary tract infections | Common | In 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 ketoacidosis | Rare: <1/1,000 in SmPC (between 0 and 2 additional events per 1,000 person-years in RCTs); real life events may be higher | Inform and advise patients and healthcare professionals about how to prevent diagnose and treat DKA |
Amputation | Uncommon: 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 lower | Encourage 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.