TYPE 2 DIABETES AFFECTS YOUR EVERYDAY LIFE

Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE. Symptoms of a serious allergic reaction may include:

• rash
• raised, red areas on your skin (hives)
• swelling of your face, lips, mouth, and throat that may cause difficulty in breathing or swallowing

If you have any of these symptoms, stop taking JARDIANCE and call your healthcare provider right away or go to the nearest hospital emergency room.

JARDIANCE can cause serious side effects, including:

• Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 and other ketoacidosis. JARDIANCE can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who are sick, cannot eat or drink as usual, skip meals, and are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking JARDIANCE and call your healthcare provider or get medical help right away if you get any of the following symptoms. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL: nausea, vomiting, stomach-area (abdominal) pain, tiredness, trouble breathing, ketones in your urine or blood.
• Dehydration. JARDIANCE can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up. Sudden worsening of kidney function has happened in people who are taking JARDIANCE. You may be at a higher risk of dehydration if you: take medicines to lower your blood pressure, including water pills (diuretics), are on a low salt diet, have kidney problems, or are 65 years of age or older. 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, if you are sick or cannot eat, or start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long.
• Vaginal yeast infection. Talk to your healthcare provider if you have vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
• Yeast infection of the skin around the penis. Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Talk to your healthcare provider if you have redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from 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 of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.
• Serious urinary tract infections. Serious urinary tract infections can occur in people taking JARDIANCE and may lead to hospitalization. Tell your healthcare provider if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea, or vomiting.
• Low blood sugar (hypoglycemia). In adults, if you take JARDIANCE with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of low blood sugar is higher. In children 10 years of age and older, the risk for low blood sugar is higher with JARDIANCE regardless of use with another medicine that can also lower blood sugar. The dose of your sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking or feeling jittery.
• Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in people who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have a fever or are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema).
• Amputations. SGLT2 inhibitors may increase your risk of lower limb amputations. You may be at a higher risk of lower limb amputation if you have a history of amputation; have had blocked or narrowed blood vessels, usually in your leg; have had diabetic foot infection, ulcers or sores. Call your healthcare provider right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Talk to your healthcare provider about proper foot care.
• Serious allergic reactions. If you have any symptoms of a serious allergic reaction stop taking JARDIANCE and call your healthcare provider right away or go to the nearest hospital emergency room.

The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females. These are not all the possible side effects of JARDIANCE. For more information, ask your healthcare provider or pharmacist.

Before you take JARDIANCE, tell your healthcare provider about all of your medical conditions, including if you have type 1 diabetes or have had diabetic ketoacidosis, have a decrease in your insulin dose, have a serious infection, have a history of infection of the vagina or penis, have a history of amputation, or have kidney or liver problems. Also tell your healthcare provider if you have a history of urinary tract infections or problems with urination. Tell your healthcare provider if you are on a low sodium (salt) diet because your healthcare provider may change your diet or dose. Tell your healthcare provider if you are going to have surgery because your healthcare provider may stop JARDIANCE before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking JARDIANCE and when to start it again. Also tell your healthcare provider if you are eating less or there is a change in your diet; are dehydrated; have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas; drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking); have ever had an allergic reaction to JARDIANCE; are pregnant or plan to become pregnant. JARDIANCE may harm your unborn baby. If you become pregnant while taking JARDIANCE, tell your healthcare provider as soon as possible. Tell your healthcare provider if you are breastfeeding or are planning to breastfeed. JARDIANCE may pass into your breast milk and may harm your baby. Do not breastfeed while taking JARDIANCE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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.

For more information, please see Prescribing Information and Medication Guide.

CL-JAR-100168 09.21.2023