LIVING WITH CHRONIC
KIDNEY DISEASE

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. 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  
  • 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.

• Genital and urinary tract infections. JARDIANCE 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 genitals. Also tell your healthcare provider if you have any of these signs or symptoms of infections: 

  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  
  • 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): 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

• 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 taking 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
• have kidney problems
• have liver problems
• have a history of urinary tract infections or problems with urination
• are on a low sodium (salt) diet. Your healthcare provider may change your diet or dose
• are going to have surgery. 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
• 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. Tell your healthcare provider right away if you become pregnant during treatment with JARDIANCE
• 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-100211 10.24.2025