MEDICATION GUIDE

 DAPAGLIFLOZIN (dap a gli FLOE zin)

tablets, USP for oral use

What is the most important information I should know about Dapagliflozin?

Dapagliflozin can cause serious side effects, including:

• Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis.Dapagliflozin 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, 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 dapagliflozinand 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	tiredness
vomiting	trouble breathing
stomach area (abdominal) pain	ketones in your urine or blood

• Dehydration.Dapagliflozincan cause some people to become dehydrated (the loss of body water and salt). Dehydration 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 dapagliflozin. 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, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long.
• Vaginal yeast infection. Women who take dapagliflozinmay get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
  • vaginal odor
  • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
  • vaginal itching
• Yeast infection of the penis (balanitis). Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:

• redness, itching, or swelling of the penis
• foul smelling discharge from the penis
• rash of 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 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.

 

What is dapagliflozin?

• Dapagliflozin is a prescription medicine used:
  • to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes who also have known cardiovascular disease or multiple cardiovascular risk factors.
  • along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
• Dapagliflozin is not for use to improve blood sugar (glucose) control in people with type 1 diabetes.
• Dapagliflozin 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.
•  It is not known if dapagliflozin is safe and effective to lower blood sugar (glucose) in children younger than 10 years of age with type 2 diabetes.

Who should not take dapagliflozin?

Do not take dapagliflozin if you:

• are allergic to dapagliflozin or any of the ingredients in dapagliflozin. See the end of this Medication Guide for a list of ingredients in dapagliflozin. Symptoms of a serious allergic reaction to dapagliflozin may include:

• 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 dapagliflozin and contact your healthcare provider or go to the nearest hospital emergency room right away.

What should I tell my healthcare provider before taking dapagliflozin?

Before you take dapagliflozin, tell your healthcare provider 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 liver problems.
• have a history of urinary tract infections or problems with urination.
• are on a low sodium (salt) diet. Your healthcare provider may ask you to change your diet.
• are going to have surgery. Your healthcare provider may stop your dapagliflozin before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking dapagliflozin 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).
• are pregnant or plan to become pregnant. Dapagliflozin may harm your unborn baby. If you become pregnant while taking dapagliflozin, your healthcare provider may switch you to a different medicine to control your blood sugar. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
• are breastfeeding or plan to breastfeed. It is not known if dapagliflozin passes into your breast milk. You should not breastfeed if you take dapagliflozin.

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

Dapagliflozin may affect the way other medicines work, and other medicines may affect how dapagliflozin works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take dapagliflozin?

• Take dapagliflozinexactly as your healthcare provider tells you to take it.
• Take dapagliflozinby mouth 1 time each day, with or without food.
• Your healthcare provider will tell you how much dapagliflozin to take and when to take it. Your healthcare provider may change your dose if needed.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 2 doses of dapagliflozin at the same time. Talk with your healthcare provider if you have questions about a missed dose.
• If you take too much dapagliflozin, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest emergency room right away.
• If you have diabetes:
  • When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider’s instructions.
  • Your healthcare provider may tell you to take dapagliflozin along with other diabetes medicines. Low blood sugar can happen more often when dapagliflozin is taken with certain other diabetes medicines. See “What are the possible side effects of dapagliflozin?”
• Dapagliflozin will cause your urine to test positive for glucose.

• Your healthcare provider may do certain blood tests before you start dapagliflozin and during treatment as needed. Your healthcare provider may change your dose of dapagliflozin based on the results of your blood tests.

What are the possible side effects of dapagliflozin?

Dapagliflozin may cause serious side effects, including:

See “What is the most important information I should know about dapagliflozin?”.

• Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
• Low blood sugar (hypoglycemia) in patients with diabetes mellitus. If you take dapagliflozin with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take dapagliflozin. Signs and symptoms of low blood sugar may include:

headache	drowsiness	weakness
confusion	dizziness	sweating
hunger	fast heartbeat	irritability
shaking or feeling jittery

• A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men with diabetes mellitus who take dapagliflozin. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries, and may lead to death. Seek medical attention rightawayif you have fever or you are feeling very weak, tired, or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals:

pain or tenderness

swelling

redness of skin (erythema)

• Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking dapagliflozin and call your healthcare provider right away or go to the nearest hospital emergency room. See “Who should not take dapagliflozin?”. Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.

The most common side effects of dapagliflozin include:

• vaginal yeast infections and yeast infections of the penis
• stuffy or runny nose and sore throat
• changes in urination, including urgent need to urinate more often, in larger amounts, or at night

These are not all the possible side effects of dapagliflozin. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store dapagliflozin?

Store dapagliflozin at room temperature between 68°F and 77°F (20°C and 25°C).

General information about the safe and effective use of dapagliflozin

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use dapagliflozin for a condition for which it is not prescribed. Do not give dapagliflozin to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about dapagliflozin. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about dapagliflozin that is written for healthcare professionals.

For more information about dapagliflozin tablets, call 1-877-272-7901.

What are the ingredients in dapagliflozin?

Active ingredient: dapagliflozin USP.

Inactive ingredients: colloidal silicon dioxide, hydroxyethyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and polysorbate 80. In addition, the film coating contains the following inactive ingredients: ferric oxide yellow, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide.

Manufactured by:

Alkem Laboratories Ltd.,

Mumbai - 400 013, INDIA.

 

Distributed by:

Ascend Laboratories, LLC

Bedminster, NJ 07921

Pediatric use information is approved for AstraZeneca AB’s Farxiga® (dapagliflozin) Tablets. However, due to AstraZeneca AB’s marketing exclusivity rights, this drug product is not labeled with that information.

 

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: May 2026

PT2969-01