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Generic Name:

dapagliflozin-metformin, Oral tablet

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  • Xigduo XR
SECTION 1 of 4

Highlights for dapagliflozin-metformin

Oral tablet
1

Dapagliflozin/metformin is used to treat type 2 diabetes.

2

Lactic acidosis is a rare, but serious, side effect of dapagliflozin/metformin where there’s a build up of lactic acid in the blood. This condition may cause death and is a medical emergency.

3

Avoid excessive alcohol use while taking dapagliflozin/metformin. Use of alcohol while taking dapagliflozin/metformin can increase your risk of lactic acidosis.

4

Dehydration is a side effect of taking dapagliflozin/metformin. Symptoms include feeling dizzy, faint, lightheaded, or weak, especially when you stand up.

5

Other common side effects include increased risk of genital infections, urinary tract infection, stomach problems, and headache.

IMPORTANT INFORMATION

FDA warning

This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to potentially dangerous effects.

Lactic acidosis warning. Lactic acidosis is a rare, but serious, side effect of this drug. It’s a buildup of lactic acid in your blood. This condition may cause death and is a medical emergency. It should be treated in the hospital. Stop taking this drug and call your doctor right away if you experience any of these symptoms of lactic acidosis:

  • feeling very tired or weak
  • unusual muscle pain
  • trouble breathing
  • unusual sleepiness or sleeping longer than usual
  • stomach pains, nausea, or vomiting
  • dizziness or lightheadedness
  • slow or irregular heartbeat

Low blood pressure

This drug can cause you to experience low blood pressure, especially if you have kidney problems, are elderly, taking medications to lower your blood pressure, or have been diagnosed with low blood pressure. Symptoms of low blood pressure include lightheadedness, dizziness, and feeling faint.

Genital infections

Use of this drug can increase the risk of genital infections in both males and females. You’re at a greater risk if you have a history of these infections or if you’re an uncircumcised male.

Ketoacidosis

This drug may cause diabetic ketoacidosis. This is a serious complication of diabetes. It happens when your body makes high levels of the blood acids called ketones. This condition should be treated with insulin. If you develop ketoacidosis, your doctor may have you stop taking this drug temporarily or permanently.

Urinary tract infections

This drug can cause severe urinary tract infections. If you have any signs of a urinary tract infection, tell your doctor right away. Symptoms can include a burning sensation when you urinate, cloudy urine, and pain in your pelvis or back.

What is dapagliflozin-metformin?

This drug is a prescription drug. It’s available as an oral extended-release tablet.

This drug is a combination of two or more drugs in a single form. It’s important to know about all the drugs in the combination because they each may have unique traits.

This drug may be taken as part of a combination therapy. That means you need to take it with other drugs.

Why it's used

This drug, when combined with lifestyle changes (diet, exercise, quitting smoking) and sometimes other medications, can help lower your blood sugar level and keep your diabetes under control.

How it works

This drug is a combination of 2 prescription medications, with each drug working differently.

More Details

How it works

This drug is a combination of 2 prescription medications, with each drug working differently.

  • Dapagliflozin: Dapagliflozin belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. A class of drugs refers to medications that work similarly. They’re often used to treat similar conditions. Dapagliflozin lowers your blood sugar by causing your kidneys to get rid of sugar in your urine.
  • Metformin: Metformin works by decreasing the amount of sugar made by your liver, decreasing the absorption of sugar by your intestines, and increasing the effect of insulin in your body. These all help to lower your glucose level.
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SECTION 2 of 4

dapagliflozin-metformin Side Effects

Oral tablet

Most Common Side Effects

The most common side effects that occur with dapagliflozin/metformin include:

  • genital/urinary infections

    • vaginal yeast infections
    • yeast infections of the penis
    • urinary tract infections. Symptoms can include:
      • a burning sensation when you urinate
      • cloudy urine
      • pain in your pelvis or back
  • stomach problems

    • nausea
    • vomiting
    • diarrhea
  • headache

  • stuffy or runny nose and sore throat

If these effects are mild, they may disappear within a few days or a couple of weeks. If they’re more severe or don’t disappear, talk to your doctor or pharmacist.

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening, or if you think you’re experiencing a medical emergency, call 9-1-1.

  • lactic acidosis. Lactic acidosis is rare. It’s a buildup of lactic acid in your blood. It may cause death and is a medical emergency. Symptoms may include:

    • feeling very tired or weak
    • unusual muscle pain
    • trouble breathing
    • unusual sleepiness or sleeping longer than usual
    • stomach pains, nausea, or vomiting
    • dizziness or lightheadedness
    • slow or irregular heartbeat
  • dehydration. Symptoms may include:

    • dizziness
    • feeling faint
    • lightheadedness
    • weakness, especially when you stand up
  • kidney damage

  • yeast infection. Symptoms in women may include:

    • vaginal odor
    • white or yellowish vaginal discharge
    • vaginal itching

    Symptoms in men may include:

    • redness, itching, or swelling of the penis
    • rash of the penis
    • foul-smelling discharge from the penis
    • pain in the skin around the penis
  • increased levels of bad cholesterol (LDL)

  • diabetic ketoacidosis. Symptoms can include:

    • excessive thirst
    • urinating more often than normal
    • nausea
    • vomiting
    • stomach pain
    • weakness
    • shortness of breath
    • fruity smelling breath
    • confusion
  • low vitamin B12 levels. Symptoms may include:

    • weakness
    • fatigue
    • rapid heartbeat
    • easy bruising
    • bleeding gums
    • stomach upset
Pharmacist's Advice
Clinical Associate Professor, University of Illinois at Chicago College of Pharmacy

This drug doesn’t cause drowsiness.

This drug can cause stomach problems, such as stomach upset, diarrhea, nausea, and vomiting. This may occur especially when you first start taking it.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 4

dapagliflozin-metformin May Interact with Other Medications

Oral tablet

Dapagliflozin/metformin can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Alcohol Interaction

Avoid drinking alcohol while taking dapagliflozin/metformin. Use of alcohol while taking dapagliflozin/metformin can increase your risk of experiencing lactic acidosis.

Medications That Might Interact with This Drug

Other diabetes drugs
  • chlorpropamide
  • glipizide
  • glimepiride
  • glyburide
  • tolbutamide
  • tolazamide
  • repaglinide
  • nateglinide

Use of dapagliflozin/metformin with these drugs may cause your blood sugar levels to drop too low (hypoglycemia).

Blood pressure drugs
  • thiazide diuretics
    • hydrochlorothiazide
    • furosemide

Use of dapagliflozin/metformin with these drugs may lower the effect of these blood pressure drugs.

  • verapamil

Use of dapagliflozin/metformin with this drug may lower the effect of this blood pressure drug. It may also increase your risk of experiencing side effects from this drug.

Hormone drugs
  • androgens
    • testosterone
  • pegvisomant
  • oral contraceptives
  • thyroid hormone

Use of dapagliflozin/metformin with these drugs may cause your blood sugar levels to drop too low (hypoglycemia).

  • danazol
  • luteinizing hormone-releasing hormone analogs
    • goserelin
    • leuprolide
    • triptorelin
  • corticosteroids (inhaled and oral)
    • prednisone
    • hydrocortisone
    • methylprednisolone
    • betamethasone
  • somatropin

Use of these drugs with dapagliflozin/metformin may lower the effectiveness of dapagliflozin/metformin.

Depression drugs
  • duloxetine

Use of this drug with dapagliflozin/metformin may increase your risk of low blood pressure when standing.

  • bupropion

Use of this drug with dapagliflozin/metformin may increase the levels of dapagliflozin/metformin in your body and increase your risk of side effects.

Seizure drugs
  • barbiturates
  • phenytoin

Use of barbiturates with dapagliflozin/metformin may increase your risk of experiencing low blood pressure. Use of phenytoin with dapagliflozin/metformin may worsen blood sugar control.

  • topiramate

Use of this drug with dapagliflozin/metformin may increase your risk of side effects from metformin.

  • lamotrigine

Use of this drug with dapagliflozin/metformin may increase the levels of metformin in your body and increase your risk of side effects.

Parkinson disease drug
  • levodopa

Use of this drug with dapagliflozin/metformin may increase your risk of low blood pressure when standing.

Antibiotics
  • cephalexin
  • trimethoprim

Use of these drugs with dapagliflozin/metformin may increase the levels of trimethoprim and cephalexin in your body and increase your risk of side effects.

X-ray drug
  • iodine as a dye or contrast

Dapagliflozin/metformin will need to be stopped for a short time if you’re going to have an injection of dye or contrast for an x-ray procedure. The dye can temporarily damage your kidneys, which can cause a build-up of metformin in your body. This may also lead to lactic acidosis.

Stomach problem drugs
  • cimetidine
  • glycopyrrolate

Use of these drugs with dapagliflozin/metformin may increase the levels of metformin in your body and increase your risk of side effects.

Heart drugs
  • dofetilide

Use of this drug with dapagliflozin/metformin may increase the levels of dofetilide in your body and increase your risk of side effects from dofetilide.

  • ranolazine

Use with dapagliflozin/metformin may increase the levels of metformin in your body and increase your risk of side effects from metformin.

Overactive bladder drug
  • trospium

Use of this drug with dapagliflozin/metformin may decrease the levels of trospium in your body and lower the effect of that medication.

Glaucoma drugs
  • brinzolamide
  • dorzolamide

Use of these drugs with dapagliflozin/metformin may increase your risk of experiencing lactic acidosis.

Cancer drug
  • vandetanib

Use of this drug with dapagliflozin/metformin may increase the levels of metformin in your body and increase your risk of side effects from metformin.

Multiple sclerosis drug
  • dalfampridine

Use of this drug with dapagliflozin/metformin may increase the levels of dalfampridine in your body and increase your risk of side effects from dalfampridine.

Human immunodeficiency virus (HIV) drug
  • dolutegravir

Use of this drug with dapagliflozin/metformin may increase the levels of metformin in your body and increase your risk of side effects from metformin.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
Drug warnings
high cholesterol
People with high cholesterol

Taking this drug may increase the level of your bad cholesterol. Your doctor should monitor your cholesterol levels regularly if you already have high levels of bad cholesterol.

kidney damage
People with moderate to severe kidney damage

If you have moderate to severe kidney damage or end-stage kidney disease, or are on dialysis, don’t take this drug. Taking metformin puts you at increased risk of lactic acidosis.

liver damage
People with liver damage

If you have liver damage, don’t take this drug. Taking metformin if you have liver damage puts you at risk for lactic acidosis.

pregnant women
Pregnant women

This drug is a category C pregnancy drug. That means two things:

  1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
  2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

If you’re pregnant, talk with your doctor about the best way to control your blood sugar while you’re pregnant.

breastfeeding
Women who are breast-feeding

This drug may pass through breast milk and may cause serious adverse effects.

Tell your doctor if you’re breastfeeding. You and your doctor may need to decide if you’ll take this drug or breastfeed.

for seniors
For seniors

If you’re 80 years old or older, don’t take this drug unless your doctor confirms that you have normal kidney function. You’re at an increased risk of lactic acidosis at this age.

allergies
Allergies

This drug can cause a severe allergic reaction. Symptoms may include:

  • trouble breathing
  • swelling of your throat or tongue
  • hives

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal. Also avoid this drug if you’ve ever had a serious reaction to dapagliflozin or metformin.

SECTION 4 of 4

How to Take dapagliflozin-metformin (Dosage)

Oral tablet

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What Are You Taking This Medication For?

Type 2 diabetes
Form: Oral extended-release tablet
Strengths: dapagliflozin 5 mg/metformin 500 mg, dapagliflozin 5 mg/metformin 1,000 mg, dapagliflozin 10 mg/metformin 500 mg, and dapagliflozin 10 mg/metformin 1,000 mg
Adult Dosage (ages 18-79 years)
  • The usual dose ranges from dapagliflozin 5 mg/metformin 500 mg, taken per once per day in the morning to dapagliflozin 10 mg/metformin 2,000 mg, taken once per day in the morning.
  • The maximum dose per day is dapagliflozin 10 mg/metformin 2,000 mg.
  • This drug isn’t recommended for people aged 80 years and older.
Child Dosage (ages 0-17 years)

Dosage for people younger than 18 years hasn’t been established.

Senior Dosage (ages 65 years and older)

If you’re 80 years old or older, don’t take dapagliflozin/metformin unless your doctor confirms that you have normal kidney function. You’re at an increased risk of lactic acidosis at this age.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Clinical Associate Professor, University of Illinois at Chicago College of Pharmacy

This drug comes with serious risks if you don't take it as prescribed.

If you don't take it at all

If you don’t take it at all, your symptoms of type 2 diabetes may not improve or even worsen over time.

If you stop taking it suddenly

If your condition improved while taking the medication regularly and you stop taking dapagliflozin/metformin suddenly, your symptoms of type 2 diabetes may come back again.

If you don't take it on schedule

If you don’t take it on schedule, this drug may not work as well in controlling your blood sugar level.

If you take too much

If you take too much of this drug, you may be at higher risk of experiencing serious side effects, such as low blood sugar (hypoglycemia).

What to do if you miss a dose

If you forget to take your dose, take it as soon as you remember, unless you remember just a few hours before your next dose. Then only take one dose. Never try to catch up by taking two tablets at once. This could result in toxic side effects.

How to tell if the drug is working

Your blood sugar level will go down if it’s high, and it will stay within the normal range.

This drug is a long-term drug treatment.

Important considerations for taking this drug
take with food
Take it with food
take in morning
Take it in the morning
don't cut or crush
Don’t cut or crush the tablet
storage
Store this drug from 68–77°F (20–25ºC)
See Details
refillable
Prescription is refillable
travel
Travel
See Details
self-management
Self-management
See Details
clinical monitoring
Clinical monitoring
See Details
not usually stocked
Not every pharmacy stocks this drug, so call ahead
prior authorization
Insurance
See Details

Store this drug from 68–77°F (20–25ºC)

When traveling, this medication can be stored from 59–86°F (15–30ºC).

Keep it away from light and high temperature.

Keep your drugs away from areas where they could get wet, such as bathrooms. Store these drugs away from moisture and damp locations.

Travel

When traveling with your medication:

  • Always carry your medication with you or in your carry-on bag.
  • Don’t worry about airport X-ray machines; they can’t hurt your medication.
  • You may need to produce your pharmacy’s preprinted label clearly identifying the medication. Keep the original pharmacy prescription-labeled box when traveling with your medication.
  • Don’t put this medicine in your glove compartment or leave it in the car, especially when the temperature is hot or freezing.

Self-management

You may have to regularly check your blood sugar level at home.

Clinical monitoring

Your doctor may do tests during your treatment with this drug to check your:

  • blood sugar level
  • hemoglobin A1c level (shows how well controlled your blood sugar levels have been over the past three months)
  • cholesterol level
  • electrolyte level
  • red blood cell count
  • kidney function

Your doctor may also monitor your blood pressure level and check for signs of a genital infection.

Insurance

Many insurance companies will require a prior authorization before they approve the prescription and pay for this drug.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.


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Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on January 21, 2016

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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