dapagliflozin / metformin

• Risk factors: Kidney or liver problems | Heart failure or heart attack | Age 65 years or older | Not eating food or fasting before surgery | Drinking large amounts of alcohol | Imaging procedure using contrast dye | Taking certain medications that affect the kidneys or acid-base balance

Metformin in Xigduo XR (dapagliflozin / metformin) can cause a rare, but serious medical condition called lactic acidosis (too much lactic acid in your blood). If left untreated, this condition can lead to other health problems, including organ failure, which can be life-threatening. Discuss with your primary care provider about your medical history before starting Xigduo XR (dapagliflozin / metformin) and any planned procedures during treatment. They can check for your risk of lactic acidosis. Get medical attention right away if you experience fast breathing, irregular heartbeat, or weakness. These can be signs that you have too much lactic acid in your blood.

• Risk factors: Lowered calorie intake | After surgery | Sudden fever | Pancreas problems | Stopping or lowering dose of insulin | Drinking too much alcohol

Dapagliflozin in Xigduo XR (dapagliflozin / metformin) can cause a rare but serious medical condition called diabetic ketoacidosis (DKA). This condition happens when you don't have enough insulin to help your body use blood sugar as a source of energy. When this occurs, your body gets energy another way by breaking down fat into a type of acid called ketone. But it can be dangerous when too many acidic ketones build up in the blood. Seek medical attention right away if you notice signs and symptoms of ketoacidosis, such as trouble breathing, vomiting, belly pain, dry skin and mouth, feeling very tired, and fruity-smelling breath.

• Risk factors: 65 years and older | History of kidney problems | Taking certain loop diuretics (water pills) | Low salt (sodium) diet

Xigduo XR (dapagliflozin / metformin) can cause low levels of fluids in the body because dapagliflozin might cause you to urinate more. This can lead to dehydration, low blood pressure, or sudden kidney injury. Very rarely, the kidney problems can require hospitalization or dialysis. You're at higher risk for these problems if you have kidney problems or are an older adult. If you have any risk factors for low fluid levels, talk with your prescriber about how you can safely take Xigduo XR (dapagliflozin / metformin). You might need to get blood and urine tests done before or during treatment so your provider can check your kidney health. Speak with your care team if you feel dizzy, confused, chest pain, or notice you're urinating less than usual while taking Xigduo XR (dapagliflozin / metformin). These might be symptoms of dehydration, low blood pressure, or kidney problems.

• Risk factors: History of urinary tract infections (UTIs) or genital yeast infections

Dapagliflozin in Xigduo XR (dapagliflozin / metformin) might raise your risk of genital and urinary tract infections, including yeast and fungal infections. Your risk of a yeast infection is higher if you've had frequent or long-term genital yeast infections in the past. In rare cases, these genital infections can be serious and life-threatening, and they might require hospitalization or surgery. Let your prescriber know if you have genital itching, pain while urinating, cloudy urine, or back pain. These can be signs of a genital yeast infection or kidney infection. Get medical attention right away if you have symptoms of a more serious infection, like pain, swelling, or redness in the genital area, along with fever and weakness.

• Risk factors: Long-term use of metformin | Lower than average calcium or vitamin B12 intake or absorption

Taking diabetes medications that contain metformin, including Xigduo XR (dapagliflozin / metformin), for a long period of time can cause your vitamin B12 levels to drop. Having low vitamin B12 levels can lead to a higher risk of anemia. Your prescriber will check your vitamin B12 levels through blood work every 2 to 3 years. If needed, your prescriber might recommend that you take vitamin B12 supplementation. Let your care team know if you frequently have low energy, dizziness, muscle problems, or tingling or numbness in your hands and feet.

Although extremely rare, people who took dapagliflozin have developed a very serious skin infection called necrotizing fasciitis. If you develop this type of infection, your prescriber will ask you to stop taking Xigduo XR (dapagliflozin / metformin) and get treated with antibiotics right away. Get medical help as soon as possible if you notice swelling, redness, tenderness, in the skin area around the genitals.

• Risk factors: Changes in diet and exercise | Drinking alcohol | Taking other diabetes medications

Xigduo XR (dapagliflozin / metformin) can raise the risk of dangerously low blood sugar when taken together with other diabetes medications, such as insulin and sulfonylureas. You might also be at risk of having low blood sugar if you've recently changed your diet, exercise, and drinking habits. Very low blood sugar can be life-threatening. Symptoms of low blood sugar include feeling shaky; feeling nervous, anxious, or confused; sweating; and having fast heartbeat, body chills, low energy, and hunger. Make sure you know how to check your blood sugar if you get these symptoms and what to do if you have low blood sugar. Talk to your prescriber about your risk for low blood sugar.