Possible side effects

FARXIGA may cause serious side effects including:

• Ketoacidosis. FARXIGA can cause ketoacidosis, a serious condition which may require hospitalization and lead to death. People with type 1 diabetes, type 2 diabetes, or pancreas problems have a high risk of getting ketoacidosis. Signs and symptoms may include nausea, tiredness, vomiting, trouble breathing, abdominal pain, and ketones in your urine or blood. If you get any of these symptoms, stop taking FARXIGA and call your healthcare provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL
• 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). There have been reports of sudden kidney injury in people with type 2 diabetes who are taking FARXIGA. You may be at a higher risk of dehydration if you take medicines to lower your blood pressure, including water pills (diuretics); are age 65 or older; are on a low salt diet, or 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, or if you experience vomiting or diarrhea
• Genital and urinary tract infections. FARXIGA can cause serious infections in your genital area or urinary tract that could require hospitalization. A rare but serious bacterial infection called necrotizing fasciitis can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). This infection may require hospitalization, multiple surgeries, and could lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop pain or tenderness, swelling, or redness of skin (erythema) in the area between and around your anus and genitalsAlso tell your healthcare provider if you have any of these signs or symptoms of infection:
  • urinary tract infection: burning feeling when you urinate, need to urinate often or right away, pain in the lower part of your stomach (pelvis), blood in your urine. You may also have a fever, back pain, nausea, or vomiting
  • vaginal yeast infection: vaginal odor, white or yellowish vaginal discharge (may be lumpy or look like cottage cheese), vaginal itching
  • yeast infection of the skin around the penis: swelling of an uncircumcised penis may make it difficult to pull back the skin around the tip of your penis. Other symptoms include: redness, itching, or swelling of the penis, bad smelling discharge from the penis, rash on the penis, and/or pain in the skin around the penis. Talk to your healthcare provider about what to do if you get symptoms of a yeast infection. They may suggest you use an over-the-counter antifungal medicine. Contact your healthcare provider right away if your symptoms do not improve after using an over-the-counter antifungal medicine
• 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

FARXIGA is a prescription medicine used to:

• improve blood sugar control along with diet and exercise in adults and children who are 10 years of age and older with type 2 diabetes

• reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors 

• reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure, when the heart cannot pump enough blood to the rest of your body 

• reduce the risk of further worsening of your kidney disease, end-stage kidney disease, death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease 
  

FARXIGA is not for use to improve blood sugar (glucose) control in people with type 1 diabetes.

FARXIGA is not for use to improve blood sugar (glucose) control in people with type 2 diabetes who have moderate to severe kidney problems, because it may not work.

FARXIGA is not for people with certain genetic forms of polycystic kidney disease, or who are taking or have recently received immunosuppressive therapy to treat kidney disease. FARXIGA is not expected to work if you have these conditions.