Dapagliflozin

Dapagliflozin (brand name Farxiga) is used to treat type 2 diabetes, heart failure, or chronic kidney disease. It is an oral tablet taken once a day.

Dapagliflozin belongs to the drug class called SGLT2 inhibitors and works by blocking sodium-glucose cotransporter 2 (SGLT2), a protein in the kidneys responsible for reabsorbing filtered glucose back into the bloodstream. By inhibiting SGLT2, dapagliflozin causes excess glucose to be excreted in the urine, which helps lower blood sugar levels.

Dapagliflozin also reduces sodium reabsorption in the kidneys, increasing sodium delivery to the distal tubule. This is thought to reduce the workload on the heart by lowering preload and afterload, downregulating sympathetic nervous system activity, and decreasing pressure within the kidneys (intraglomerular pressure).

Dapagliflozin was first approved by the FDA on January 8, 2014, under the brand name Farxiga. Generic versions are also available.

Dapagliflozin is FDA-approved to:

• to reduce the risk of further worsening of your kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease
• to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure, when the heart cannot pump enough blood to the rest of your body
• 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 and children who are 10 years of age and older with type 2 diabetes.

Dapagliflozin is not for use:

• in people with type 1 diabetes to improve blood sugar (glucose) control
• in people with type 2 diabetes who have moderate to severe kidney problems, because it may not work to improve blood glucose control
• for people with certain genetic forms of polycystic kidney disease, or who are taking or have recently received immunosuppressive therapy to treat kidney disease. It is not expected to work if you have these conditions.

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, or for children younger than 18 years of age to treat heart failure or chronic kidney disease.

Take dapagliflozin exactly as your healthcare provider tells you to take it.

• Take dapagliflozin by mouth, 1 time per 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.

Do not take dapagliflozin if you are allergic to dapagliflozin or any of the ingredients in dapagliflozin.

• Symptoms of a serious allergic reaction to dapagliflozin may include rash, raised red patches on your skin (hives), or 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.

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
• are breastfeeding or plan to breastfeed. It is not known if dapagliflozin passes into your breast milk. You should not breastfeed while taking 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. Keep a list of all your medicines to show your healthcare provider and pharmacist when you get a new medicine.

Common side effects

The most common side effects of dapagliflozin are:

• 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.

Important information and serious side effects

Dapagliflozin can cause the following serious side effects:

Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidoses.

Dapagliflozin can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition that 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 pancreatic 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 dapagliflozin 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 tiredness vomiting trouble breathing stomach area (abdominal) pain ketones in your urine or blood.

Dehydration

Dapagliflozin can 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.

Genital and urinary tract infections

Dapagliflozin 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 any of the following symptoms in the area between and around your anus and genitals:

• pain or tenderness
• swelling
• redness of skin (erythema).

Also, tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast 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), or 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), or vaginal itching.
• Yeast infection of the skin around the penis (balanitis or balanoposthitis): if you are uncircumcised, swelling 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, rash on the penis, bad-smelling discharge from the penis, 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) 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 belowered 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

Serious allergic reactions

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.

Notes:

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 the FDA at 1-800-FDA-1088.

Patients should be well hydrated before starting treatment with dapagliflozin.

Withhold dapagliflozin for at least 3 days, if possible, before surgery or procedures associated with prolonged fasting.

Dose of dapagliflozin for type 2 diabetes (adults and children 10+)

• Initial dose: dapagliflozin 5 mg orally once daily
• May increase to 10 mg orally once a day for additional glycemic control if a lower dose has been tolerated
• Maximum dose: 10 mg/day orally.

Dose of dapagliflozin for heart failure and kidney disease

• Initial and maintenance dose: 10 mg orally once a day

Other drugs may increase or decrease the effects of dapagliflozin on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

• Insulin or other oral diabetes medicines
• A diuretic or "water pill", such as furosemide or HCTZ
• Lithium.

Dapagliflozin will increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative ways to monitor glycemic control. It also interferes with some other laboratory assays.

This list is not complete. Other drugs may interact with dapagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Because of the prescription drug law known as the Inflation Reduction Act, Medicare can negotiate directly with drug companies to improve access to some of the costliest single-source brand-name Medicare Part B and Part D drugs.

Dapagliflozin was one of 10 drugs covered under Medicare Part D selected in 2023 for the first cycle of negotiation, based on total expenditures under Part D and other criteria required by the law. The negotiated price for dapagliflozin took effect on January 1, 2026. Under this agreement, the negotiated price is $178.50 for a 30-day supply, down from the 2023 list price of $556, a discount of around 68%

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

Active: dapagliflozin.

Inactive: anhydrous lactose, crospovidone, magnesium stearate, microcrystalline cellulose, and silicon dioxide.

The film coating contains: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.

Available as dapagliflozin 5 mg and 10 mg tablets.

Dapagliflozin is available under the brand name Farxiga, manufactured by AstraZeneca Pharmaceuticals LP, and as generic tablets manufactured by other companies.