INDICATION AND IMPORTANT SAFETY INFORMATION FOR FARXIGA
WHAT IS FARXIGA™ (dapagliflozin)?
FARXIGA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).
IMPORTANT SAFETY INFORMATION FOR FARXIGA
Do not take FARXIGA™ (dapagliflozin) if you are allergic to dapagliflozin or any of the ingredients in FARXIGA. Symptoms of a serious allergic reaction to FARXIGA may include: skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking FARXIGA and contact your healthcare provider or go to the nearest hospital emergency room right away.
Do not take FARXIGA if you have severe kidney problems or are on dialysis. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with FARXIGA.
Serious side effects can happen in people who take FARXIGA, including:
- Dehydration (the loss of body water and salt) which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure, including water pills (diuretics), are 65 years of age or older, are on a low salt diet, or have kidney problems.
- Low blood sugar (hypoglycemia) can occur if you take FARXIGA with another medicine that can cause low blood sugar, such as sulfonylureas or insulin. Symptoms of low blood sugar include shaking, sweating, fast heartbeat, dizziness, hunger, headache and irritability. Follow your healthcare provider's instructions for treating low blood sugar.
- Vaginal yeast infections in women who take FARXIGA. Talk to your healthcare provider if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching.
- Yeast infection of skin around the penis (balanitis) in men who take FARXIGA. Talk to your healthcare provider if you experience redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; or pain in the skin around penis. Certain uncircumcised men may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis.
- Increase in bad cholesterol (LDL-C). Your healthcare provider should check your LDL-C during treatment with FARXIGA.
- Bladder cancer. In studies of FARXIGA in people with diabetes, bladder cancer occurred in a few more people who were taking FARXIGA than in people who were taking other diabetes medications. There were too few cases of bladder cancer to know if bladder cancer was related to FARXIGA. Tell your healthcare provider right away if you have blood or a red color in your urine or pain while you urinate.
- Kidney problems
Tell your healthcare provider if you are pregnant. FARXIGA may harm your unborn baby.
Tell your healthcare provider if you are breastfeeding, or plan to breastfeed. It is unknown if FARXIGA passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
The most common side effects of FARXIGA include yeast infections of the vagina or penis, urinary tract infections, and changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
Please read full Prescribing Information
and Medication Guide
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.