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Farxiga®

Pronunciation: FAR-SEE-GUH
Generic name: dapagliflozin
Dosage form: oral tablets
Drug class: SGLT-2 inhibitors

What is Farxiga?

Farxiga (dapagliflozin) is an oral medication that may be given to certain people with diabetes, heart disease, or kidney disease to improve their outcomes. Specifically, Farxiga is used to:

Improve blood sugar control in adults and children aged 10 years and older with type 2 diabetes mellitus alongside diet and exercise

Lower the risk of going to hospital for heart failure in adults with type 2 diabetes who also have cardiovascular disease or multiple risk factors for cardiovascular disease

Reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure

Lower the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Farxiga mechanism of action involves preventing glucose reabsorption in the kidneys, and increasing how much is excreted in the urine. Farxiga works by inhibiting sodium-glucose cotransporter 2 (SGLT2), which is present in the proximal renal tubules and reabsorbs filtered glucose. By inhibiting this, Farxiga promotes the excretion of glucose in the urine.

Farxiga also works by reducing the amount of sodium reabsorbed by the kidneys and increasing how much reaches the distal tubule. This is thought to influence several physiological functions including lowering the preload and afterload of the heart, downregulating sympathetic activity, and decreasing pressure inside the kidneys.

Farxiga first gained FDA approval on January 8, 2014. There is no Farxiga generic.

Farxiga side effects

The most common side effects of Farxiga are:

Female genital yeast infections (vaginal thrush)

Urinary tract infections

Nasopharyngitis (a runny or stuffy nose).

Serious side effects

Farxiga can cause the following serious side effects.

Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. Farxiga 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 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 FARXIGA and call your healthcare provider or get medical help right away if you get any of the following:

nausea

tiredness

vomiting

trouble breathing

stomach area (abdominal) pain

ketones in your urine or blood.

If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.

Dehydration. Farxiga may cause dehydration. Dehydration may lead to low blood pressure, especially when you stand up (orthostatic hypotension), or kidney damage. Call your healthcare provider right away if you have any of the following symptoms of dehydration, low blood pressure, or kidney damage.

Dizziness or lightheadedness

Weakness or unusual tiredness

Confusion

Unsteadiness

Peeing less than normal

Swelling in your legs, ankles, and feet

Loss of appetite/nausea

Difficulty catching your breath or chest pain/pressure

Seizures

Extreme thirst

Urosepsis and Pyelonephritis. Farxiga may cause pyelonephritis (a kidney infection) or urosepsis (an untreated urinary tract infection that spreads to your kidney). These are serious infections and may need to be treated in the hospital. Get help right away if you have any of the following symptoms of these serious infections.

Dark, cloudy, or bloody pee or pee that smells bad

Fever and chills

Loss of appetite

Needing to pee a lot or feeling pain when you pee

Pain in your lower back, side, or groin

Upset stomach, nausea, and vomiting

Low Blood Sugar (Hypoglycemia). Farxiga can cause low blood sugar, especially when combined with insulin or other medicines that increase your insulin levels. Low blood sugar can be serious and may lead to death. You may need a lower dose of your other diabetes medicine to reduce your risk of hypoglycemia. Do not take Farxiga and call your healthcare provider right away if you have any of the following symptoms of hypoglycemia.

Headache

Crankiness or anxiety

Hunger

Dizziness or confusion

Blurry vision

Slurred speech

Sweating

Feeling jittery or shakiness

Fast heartbeat

Seizures

Necrotizing Fasciitis (Fournier’s Gangrene). Farxiga can cause necrotizing fasciitis (an aggressive infection of the skin and the tissue underneath the skin that causes some of the tissue involved to die). Necrotizing fasciitis is rare, but very serious, can lead to death, and may require surgery to treat it. Get help right away if you have any of the following symptoms of this serious infection.

Pain, redness, tenderness, or swelling of the perineum (of and around the anus and genitals)

Fever

General feeling of illness or discomfort

Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink daily. 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 liquid from your body, for example from vomiting, diarrhea, or being in the sun too long.

Vaginal yeast infections in women who take FARXIGA. Talk to your healthcare provider if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching

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). in men who take FARXIGA. Talk to your healthcare provider if you experience redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; or pain in the skin around penis. Certain uncircumcised men may have swelling of the penis 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.

Allergic reactions. Farxiga may cause an allergic reaction. Do not take Farxiga if you have a history of serious hypersensitivity reactions to dapagliflozin, Farxiga, or any of the inactive ingredients in the tablets. Serious reactions, including anaphylaxis and angioedema, have been reported.

Farxiga should not be used in patients with type 1 diabetes to improve blood sugar control because it may increase their risk of diabetic ketoacidosis.

Not recommended to improve blood sugar control in people with type 2 diabetes with moderate to severe kidney disease (an eGFR of less than 45 mL/min/1.73 m2) (likely to be ineffective in this setting).

Dosages of insulin or other medications that increase insulin release may need reducing to avoid the risk of hypoglycemia. Farxiga may increase the risk of hypoglycemia developing when combined with these medications.

Some side effects may be more likely to occur in older adults.

There may be other side effects of Farxiga that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

Before taking this medicine

You should not use Farxiga if you are allergic to dapagliflozin, or if you have:

severe kidney disease (or if you are on dialysis)

diabetic ketoacidosis (call your doctor for treatment).

To make sure Farxiga is safe for you, tell your doctor if you:

have type 1 diabetes or have had diabetic ketoacidosis

have polycystic kidney disease

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 Farxiga before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking Farxiga 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

are breastfeeding or plan to breastfeed.

Pregnancy & Breastfeeding

While it’s very important to manage diabetes during pregnancy, it’s not known if Farxiga is safe to take during this time. It is not recommended that a person take Farxiga during the second and third trimesters.

If you’re pregnant or can become pregnant, talk with your doctor about other medications that may be better options for you.

Farxiga isn’t recommended if you’re breastfeeding. It’s not known if the drug passes into breast milk. But if it does, it could cause serious side effects in a child who’s breastfed.

If you’re breastfeeding or plan to breastfeed, ask your doctor to suggest other medications to treat your condition.

How should I take Farxiga?

Take Farxiga exactly as your doctor prescribed. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Farxiga is taken 1 time per day.

You may take Farxiga with or without food.

Your treatment may include dietary changes, exercise, weight control, and special medical care.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Farxiga can cause life-threatening ketoacidosis. Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in the urine.

During prolonged illness, you may become dehydrated. Call your doctor if you are sick with vomiting or diarrhea or if you eat or drink less than usual.

Farxiga dosing information

Farxiga is available in the following dosage forms that are taken by mouth.

5 mg oral tablets

10 mg oral tablets

Patients should be well hydrated before starting treatment with Farxiga.

Recommended Farxiga dose for adults and children aged 10 and older for Type 2 diabetes to improve blood sugar control

Initial dose: Farxiga 5 mg once daily

May increase to 10 mg orally once a day for additional glycemic control if a lower dose has been tolerated

Maximum dose: Farxiga 10 mg/day

Usual adult dose of Farxiga for heart failure and kidney disease

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

Maximum dose: Farxiga 10 mg/day.

Should Farxiga be stopped for surgery?

The Farxiga Package Insert recommends withholding Farxiga for at least 3 days, if possible, before major surgery or procedures associated with prolonged fasting. Farxiga should be restarted once the person is clinically stable and has started eating or receiving nutrition again.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away

What should I avoid while taking Farxiga?

There are no known interactions between Farxiga and foods or drinks.

Being on a low-salt diet while taking Farxiga may increase your risk of dehydration. See the Side Effects section for more details.

Drinking alcohol often or too much alcohol while taking Farxiga may increase your risk of diabetic ketoacidosis. See the Side Effects section for more details. It is unknown if drinking alcohol will affect Farxiga in other ways, but alcohol may affect blood sugar levels in people with diabetes. This may interfere with the effect of Farxiga. It is best to limit the amount of alcohol you drink.

What other drugs will affect Farxiga?

Other drugs may increase or decrease the effects of Farxiga 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, also called a water pill, which is a medicine used to reduce edema (fluid retention) and blood pressure, such as furosemide or HCTZ

Lithium, which is a medicine for certain mental health conditions.

Farxiga 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.

Farxiga and Medicare

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.

Farxiga is one of 10 drugs covered under Medicare Part D that were selected in 2024 for the first cycle of negotiation based on Total Expenditures under Part D and other criteria as required by the law. Negotiations with participating drug companies are ongoing, and any negotiated prices for the first cycle of negotiation is effective from 2026.

Storage

Store at room temperature 20°C to 25°C (68°F to 77°F) away from moisture and heat. Excursions are permitted between 15°C and 30°C (59°F and 86°F).

Similar drugs

Other drugs are available that can treat your condition. If you’d like to explore an alternative to Farxiga, talk with your doctor. They can tell you about other medications that might work well for you.

The following drugs are similar to Farxiga:

canagliflozin (Invokana)

empagliflozin (Jardiance)

ertugliflozin (Steglatro) (pdf)

dapagliflozin/metformin (Xigduo XR)

Who makes Farxiga?

AstraZeneca Pharmaceuticals LP. makes Farxiga.

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