Dapagliflozin

What are the side effects of dapagliflozin?

Dapagliflozin may cause serious side effects, including:

• See “Important information” above.
• 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:
  • nausea
  • vomiting
  • stomach area (abdominal) pain
  • tiredness
  • trouble breathing
    
    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:
  • headache
  • shaking or feeling jittery
  • irritability
  • fast heartbeat
  • weakness
  • drowsiness
  • sweating
  • confusion
  • dizziness
  • hunger
• 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:
  • pain or tenderness
  • swelling
  • redness of skin (erythema)

The most common side effects of dapagliflozin include:

• vaginal yeast infections and yeast infections of the penis
• stuffy or runny nose and sore throat
• changes in urination, including urgent need to urinate more often, in larger amounts, or at night

These are not all the possible side effects of dapagliflozin. For more information, ask your healthcare provider or pharmacist.