Class Name(s):

• 68:20.18 Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors

Pronunciation:

• (dap'' a gli floe' zin)

Brand Name(s):

• Farxiga^®
• Qtern^® (as a combination product containing Dapagliflozin, Saxagliptin)
• Qternmet^® XR (as a combination product containing Dapagliflozin, Metformin, Saxagliptin)¶
• Xigduo^® XR (as a combination product containing Dapagliflozin, Metformin)

WHY is this medicine prescribed?

Dapagliflozin is used

• to lower blood sugar in people with type 2 diabetes (condition in which blood sugar is too high because the body does not make or use insulin normally).
• to reduce the risk of being hospitalized for heart failure in certain adults with type 2 diabetes
• to reduce the risk of being hospitalized for heart failure and death in adults with heart failure
• to reduce the risk of worsening of kidney disease, being hospitalized for heart failure, and death in certain adults with kidney disease

Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. Dapagliflozin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking dapagliflozin, making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

HOW should this medicine be used?

Dapagliflozin comes as a tablet to take by mouth. Take with or without food once a day. Take dapagliflozin at around the same time every day.

Take dapagliflozin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of dapagliflozin and increase your dose if needed.

Dapagliflozin helps to control your condition but does not cure it. Continue to take dapagliflozin even if you feel well. Do not stop taking dapagliflozin without talking to your doctor.

You will be given you the Medication Guide when you begin treatment with dapagliflozin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking dapagliflozin,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you regularly drink alcohol or sometimes drink large amounts of alcohol in a short time (binge drinking), if you are on a low sodium diet, or if you have an infection. Also tell your doctor if you have or have ever had heart failure, pancreatic disease including pancreatitis or have had surgery on your pancreas, urinary tract infections or problems urinating, low blood pressure, yeast infections in the genital area, or kidney or liver disease. If you are male, tell your doctor if you have never been circumcised. Also, tell your doctor if you are eating or drinking less due to illness, surgery or a change in your diet; if you are following a ketogenic diet (a high fat, low carbohydrate diet); or have recently had diarrhea, vomiting, been in the sun too long, or have been sweating a lot, which may cause dehydration (loss of a large amount of body fluids).
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Do not breastfeed while you are taking dapagliflozin. If you become pregnant while taking dapagliflozin, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dapagliflozin. Your doctor will probably tell you to stop taking dapagliflozin at least 3 days before a surgery.
• alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are taking dapagliflozin.
• you should know that dapagliflozin may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. If you have this problem, call your doctor. This problem is more common when you first start taking dapagliflozin. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of dapagliflozin you may need.

What SPECIAL DIETARY instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet and exercise regularly.

Follow your doctor's instructions about drinking enough fluids throughout the day while you are on this medication.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Dapagliflozin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• urinating a lot, including at night
• stuffy or runny nose
• sore throat
• leg or arm pain
• constipation

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• frequent, urgent, burning, or painful urination; urine that is cloudy, red, pink, or brown; strong smelling urine; decrease in amount of urine; fever, back pain, nausea or vomiting
• dry mouth, dark urine, decreased sweating, dry skin, and other signs of dehydration
• pelvic or rectal pain
• (in women) vaginal odor, white or yellowish vaginal discharge (may be lumpy or look like cottage cheese), or vaginal itching
• (in men) redness, itching, or swelling of the penis; rash on the penis; foul smelling discharge from the penis; or pain in the skin around the penis
• feeling tired, weak, or uncomfortable; along with a fever and pain, tenderness, redness, and swelling of the genitals or the area between the genitals and the rectum

If you experience any of the following symptoms, stop taking dapagliflozin and call your doctor immediately or get emergency medical treatment:

• rash; hives; itching; difficulty breathing or swallowing; hoarseness; or swelling of the face, throat, tongue, lips, mouth, or eyes

If you experience any of the following symptoms of ketoacidosis, stop taking dapagliflozin and call your doctor immediately or get emergency medical treatment. If possible, check for ketones in your urine if you have these symptoms, even if your blood sugar is less than 250 mg/dL:

• nausea, vomiting, stomach-area pain, tiredness, or difficulty breathing

Dapagliflozin can cause dehydration. It is important that you drink plenty of water while taking dapagliflozin. Talk to your doctor or pharmacist about the right amount of water to drink to prevent dehydration while taking dapagliflozin.

Dapagliflozin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will probably order certain laboratory test before and during your treatment to check your body's response to dapagliflozin.

Your blood sugar levels should be checked regularly to determine your response to dapagliflozin. Your doctor will order other lab tests, including glycosylated hemoglobin (HbA1c), to check your response to dapagliflozin. Your doctor will also tell you how to check your response to this medication by measuring your blood sugar levels at home. Follow these instructions carefully.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking dapagliflozin. Because of the way this medication works, your urine may test positive for glucose.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 15, 2025.