Dapagliflozin and metformin is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. This medicine is not for treating type 1 diabetes.

Dapagliflozin and metformin is also used to lower the risk of needing to be in the hospital for heart failure in adults with type 2 diabetes who also have heart disease.

Dapagliflozin and metformin is also used to reduce the risk of worsening kidney disease and death due to heart problems, and the need to be in the hospital for heart failure in adults with type 2 diabetes who also have chronic kidney disease.

Dapagliflozin and metformin may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to dapagliflozin (Farxiga) or metformin, or if you have

• severe kidney disease (or if you are on dialysis); or
• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking dapagliflozin and metformin.

Tell your doctor if you have ever had:

• liver or kidney disease;
• a bladder infection or urination problems;
• heart problems, low blood pressure;
• problems with your pancreas, including surgery; or
• if you are on a low salt diet.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.

Tell your doctor right away if you become pregnant. You should not use dapagliflozin and metformin during the second or third trimester of pregnancy.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while using this medicine.

Dapagliflozin and metformin is not approved for use by anyone younger than 18 years old.

Use Xigduo XR (Dapagliflozin And Metformin) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Call your doctor at once if you have:

• little or no urination;
• signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back;
• dehydration symptoms--dizziness, weakness, feeling light-headed (like you might pass out);
• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Side effects may be more likely to occur in older adults.

Common side effects may include:

• genital infections;
• headache;
• nausea, vomiting, diarrhea; or
• runny or stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.