Information to patients taking (canagliflozin, dapagliflozin and empagliflozin)

The following information only applies if you are currently taking this medication. (canagliflozin, dapagliflozin and empagliflozin)

Cases of a rare but serious infection of the genitals and areas around them have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious condition, called necrotizing fasciitis of the perineum or Fournier’s gangrene, can progress quickly and must be treated immediately because it can cause severe damage to the tissues around the genital area.

Seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly.

SGLT2 inhibitors can also cause local genital fungal infections, also known as yeast infections. Yeast infections are different from necrotizing fasciitis of the perineum (Fournier’s gangrene) because they cause limited local symptoms like vaginal or penile discharge, itching, or redness, and are not associated with fever or generally feeling unwell.

Read the patient information leaflet every time you receive a prescription for an SGLT2 inhibitor because there may be new or important additional information about your drug. The Medication Guide explains the benefits and risks associated with the medicine.