• Dehydration. Dapagliflozin can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury in people with Type 2 diabetes who are taking dapagliflozin. You may be at a higher risk of dehydration if you:
o take medicines to lower your blood pressure, including water pills (diuretics)
o are 65 years of age or older
o are on a low salt diet
o have kidney problems
Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long.
• Vaginal yeast infection. Women who take dapagliflozin may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
o vaginal odor
o white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
o vaginal itching
• Yeast infection of the penis (balanitis). Men who take dapagliflozin may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
o redness, itching, or swelling of the penis
o rash of the penis
o foul smelling discharge from the penis
o pain in the skin around the penis
Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.
• Ketoacidosis in people with diabetes mellitus (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with dapagliflozin. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with dapagliflozin. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death.
Ketoacidosis can happen with dapagliflozin even if your blood sugar is less than 250 mg/dL. Stop taking dapagliflozin and call your healthcare provider right away if you get any of the following symptoms:
o trouble breathing
o stomach area (abdominal) pain
If you get any of these symptoms during treatment with dapagliflozin, if possible, check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
• Low blood sugar (hypoglycemia) in patients with diabetes mellitus. If you take dapagliflozin with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take dapagliflozin. Signs and symptoms of low blood sugar may include:
o shaking or feeling jittery
o fast heartbeat
• A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men with diabetes mellitus who take dapagliflozin. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals:
o pain or tenderness
o redness of skin (erythema)