Xigduo XR (Dapagliflozin and Metformin) – Oral

Warning:

Lactic acidosis: Xigduo XR may cause lactic acidosis (too much acid in the blood). This can result in hypotension (very low blood pressure), hypothermia (dangerously low body temperature), very slow heart rate with arrhythmias (irregular heartbeats), or death.

The risk is worse in people having surgery, exams, or contrast tests. The risk also increases in people with kidney or liver issues, heart failure, or who drink alcohol. If you have a slow or fast heartbeat, shortness of breath, muscle cramps, or feeling cold, stop taking Xigduo XR. Go to your nearest hospital and contact your healthcare provider.

What Is Xigduo XR?

Xigduo XR is a combination drug containing dapagliflozin (as found in the brand Farxiga) and metformin (as found in the brand Glucophage). It is commonly taken in addition to diet and exercise to help control blood sugar and treat adults with type 2 diabetes mellitus, a common chronic condition characterized by the way your body regulates and uses glucose as fuel.

This drug belongs to two drug classes: sodium-glucose cotransporter 2 (SGLT2) inhibitor and biguanides. This drug is used in adults. It is only available with a prescription and as a tablet.

Dapagliflozin stops your body from reabsorbing glucose. Hence, more glucose is flushed out of your body when you urinate. It may also help your heart work better.

Metformin lowers how much glucose your liver makes and the amount of glucose your body absorbs. It also increases insulin sensitivity in your body so that your body can readily use insulin.

Drug Facts

Generic Name: Dapagliflozin and metformin

Brand Name(s): Xigduo XR

Drug Availability: Prescription

Therapeutic Classification: Sodium-glucose cotransporter 2 (SGLT2) inhibitor and biguanide.

Available Generically: No

Controlled Substance: N/A

Administration Route: Oral

Active Ingredient: Dapagliflozin and metformin

Dosage Form(s): Tablet

What Is Xigduo XR Used For?

Xigduo XR (dapagliflozin and metformin) is used to lower blood sugar in adults with type 2 diabetes, a condition affecting people around the world. Xigduo also lessens the risk of dying from or going to the hospital due to heart failure.

Do not use this medicine if you have type 1 diabetes mellitus or diabetic ketoacidosis (DKA). Xigduo XR is also indicated in people with specific kidney problems to lower their risk of worsening kidney issues.

Xigduo XR (Dapagliflozin and Metformin) Drug Information: A person and their pancreas

Verywell / Dennis Madamba

How to Use Xigduo XR 

Take in the morning with food to reduce stomach upset. Swallow it whole. Do not crush or chew the tablet. Continue taking this medicine as directed by your healthcare provider, even if you feel better.

Storage

Store Xigduo XR at room temperature (68 to 77 degrees Fahrenheit) in a dry place away from children and pets. Excursions are allowed between cool and mildly hot temperatures (59 to 86 degrees). Do not store it in your bathroom. 

Keep your medications out of the reach of children and pets, ideally locked in a cabinet or closet.

If you plan to travel with Xigduo XR, become familiar with your final destination's regulations. In general, be sure to make a copy of your Xigduo XR prescription. If possible, keep your medication in its original container from your pharmacy with your name on the label. If you have any questions about traveling with your medicine, be sure to ask your pharmacist or healthcare provider.

Discard all unused and expired drugs, but do not pour them down the drain or in the toilet. Ask your pharmacist or healthcare provider for the best ways to dispose of this medicine. And check out medication take-back programs in your area.

How Long Does Xigduo XR Take to Work?

It takes two hours for dapagliflozin to peak in your system. Metformin starts working within days, and effects are seen after about two weeks of use.

What Are the Side Effects of Xigduo XR?

This is not a complete list of side effects. Others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 800-FDA-1088.

Many people notice no negative side effects at all from taking Xigduo XR. However, some people do experience problems while taking the medication.

Common Side Effects

Common side effects of Xigduo XR include but are not limited to:

  • Headache
  • Vomiting
  • Throat and nose irritation
  • Diarrhea
  • Nausea
  • Urinary tract infections (ITIs)
  • Fungal infections of the genitals
  • Tablet shell in stool

Severe Side Effects

Xigduo XR can cause many side effects. Some may be life-threatening. Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you have a medical emergency.

Severe side effects include signs and symptoms of:

Urinary tract infections like: 

  • Lower abdominal pain
  • Blood in the urine
  • Burning or pain when passing urine

Lactic acidosis like:

  • Abnormal heartbeat
  • Feeling cold
  • Muscle pain or cramps

Kidney problems like:

  • Blood in the urine
  • Unable to pass urine

Low blood sugar like: 

  • Headache
  • Shaking
  • Sweating

Fluid and electrolyte problems like: 

  • Confusion
  • Increased thirst
  • Seizures

Sometimes experiencing very low blood sugar levels can happen while on this medicine. Call your healthcare provider if you have signs of low blood sugar. You may need to take some glucose tablets, glucose liquid, or drink orange juice.

Xigduo may also increase your risk for:

  • Bone fracture (in people with moderate kidney problems)
  • Hypotension (in adults over the age of 65, people on other blood pressure medicines) 
  • Necrotizing fasciitis, a rare but severe infection
  • Lactic acidosis
  • Dehydration
  • Vitamin B12 deficiency (due to long term use of metformin)
  • Ketoacidosis (sometimes fatal)

Factors that may increase your risk of ketoacidosis while on this medication include:

  • Restricting your calorie intake (for example, from dieting)
  • Consuming alcohol
  • Stress
  • Surgery
  • Lowering your insulin dose
  • Acute illness with fever
  • Insulin dependency by your pancreas

Report Side Effects

Xigduo may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much of Xigduo XR Should I Take?

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release tablets):
    • For type 2 diabetes:
      • Adults—At first, 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than dapagliflozin 10 mg and metformin 2000 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • To lower risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular (heart or blood vessel) disease:
      • Adults—10 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.
    • To lower risk of cardiovascular death and hospitalization in patients with heart failure:
      • Adults—10 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.
    • To lower risk of worsening of kidney disease, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease:
      • Adults—10 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.

Modifications

People of childbearing age: Metformin, an ingredient in Xigduo XR, may increase ovulation, resulting in unplanned pregnancies in people of childbearing age. Routine use of contraceptives may lower the risk of unexpected pregnancies.

Pregnancy: Dapagliflozin, an ingredient in Xigduo XR, should not be used during the second and third trimesters of pregnancy because it may harm kidney development in a fetus.

Breastfeeding: The manufacturer does not recommend nursing due to the potential of severe adverse reactions in the breastfeeding infant.

Children: Xigduo XR is not approved for use in children younger than 18 years old.

People over 65 years: This population should use with caution due to a possible increased risk of metformin-associated lactic acidosis.

People going into surgery: Your healthcare provider should temporarily stop your medicine at least three days before your surgery to lower the risk of ketoacidosis.

Missed Dose

Take the missed dose once you think of it. If it is too close to your next dose, skip the missed dose. Return to your regular schedule. Do not take extra pills or double your amount.

Try to find ways that work for you to help yourself remember to routinely take your medication.

Overdose: What Happens If I Use Too Much Xigduo XR?

Overdose of Xigduo XR may cause lactic acidosis with symptoms like confusion or rapid breathing.

What Happens If I Overdose on Xigduo?

If you think you or someone else may have overdosed on Xigduo XR, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Xigduo XR, call 911 immediately.

Precautions

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It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Serious allergic reactions may occur with this medicine. Check with your doctor right away if you have a skin rash, hives or welts, itching, redness of the skin, trouble breathing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals.

Using this medicine during the second and third part of your pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause some women who do not have regular monthly periods to ovulate. This can increase the chance of pregnancy. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

It is very important to follow carefully any instructions from your doctor about:

  • Alcohol—Drinking alcohol may cause severe low blood sugar and increase risk for lactic acidosis. Discuss this with your doctor.
  • Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
  • Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
  • Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
  • In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Under certain conditions, too much metformin can cause a serious condition called lactic acidosis. The symptoms of lactic acidosis are severe and appear quickly. Lactic acidosis usually occurs when other serious health problems are present, such as a heart attack or kidney failure. Check with your doctor right away if you have decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, stomach discomfort, and unusual sleepiness, tiredness, or weakness.

Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Taking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.

Ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination, or stomach pain.

Tell your doctor if you have bloody urine, decrease in how much or how often you urinate, painful or difficult urination, lower back or side pain, fever, chills, or swelling of the face, finger, or lower legs. These may be symptoms of a serious kidney problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, urine glucose tests may not be accurate). Also, you may need to stop taking this medicine at least 3 days before you have a surgery.

This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.

This medicine may increase risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.

This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). Fournier's gangrene may lead to hospitalization, multiple surgeries, or death. Check with your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with other diabetes medicines (eg, insulin, glipizide, glyburide). The symptoms of low blood sugar must be treated before they cause you to pass out. People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual. Some symptoms of high blood sugar include: blurred vision, drowsiness, dry mouth, flushed and dry skin, fruit-like breath odor, increased frequency and amount of urination, ketones in the urine, loss of appetite, nausea or vomiting, rapid and deep breathing, tiredness, or unusual thirst. If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn't Take Xigduo XR?

Avoid taking Xigduo XR if you have:

  • Hypersensitivity to dapagliflozin, metformin, or any of their ingredients (ask your pharmacist for a complete list of ingredients if you're unsure)
  • End-stage kidney disease, or are on hemodialysis.
  • Metabolic acidosis (diabetic ketoacidosis, with or without coma)

Xigduo is not recommended in children, people who are breastfeeding, and some pregnant people. Consult your healthcare provider to ensure that this medicine is right for you. 

What Other Medications Interact With Xigduo XR?

Using alcohol with Xigduo XR may increase the risk for severe side effects like ketoacidosis, which may be life-threatening.

Carbonic anhydrase inhibitors might increase your risk of lactic acidosis. Your healthcare provider will work with you to monitor your symptoms more closely.

Drugs that reduce metformin clearance and increase metformin levels in the body, such as:

Be sure to talk with your healthcare provider about any other medicines that you take or plan to take, including over-the-counter (OTC) and prescription products, vitamins, herbs, and plant-based medicines.

What Medications Are Similar?

Other drugs similar to Xigduo XR that are antidiabetic agents include:

This is a list of drugs also prescribed to treat diabetes. It is not a list of medicines recommended to take with Xigduo XR. You should not take these drugs together unless your healthcare provider tells you to.

Ask your pharmacist or a healthcare practitioner if you have questions.

Frequently Asked Questions

  • What is Xigduo XR used to treat?

    Xigduo XR is used to lower blood glucose in adults with type 2 diabetes.

  • What are the common side effects of Xigduo XR?

    Common side effects of Xigduo XR include:

    • Vomiting
    • Headache
    • Nose and throat irritation
    • Urinary tract infections (UTIs)
    • Diarrhea
    • Nausea
    • Fungal infections of the genitals
    • Tablet shell in stool
  • Can I break Xigduo XR in half?

    No. Swallow it whole. Do not break, chew, or crush the tablet.

  • Can I drink alcohol while on Xigduo XR?

    No, it is best to avoid drinking alcohol with this medicine. Using alcohol increases the risk for a severe and sometimes fatal side effect known as ketoacidosis.

  • What should I do if I miss a dose of Xigduo XR?

    Take the missed dose as soon as you think of it. If it is too close to your next dose, skip it. Return to your regular dosing schedule. Do not take extra doses or double the amount.

How Can I Stay Healthy While Taking Xigduo XR?

Controlling your blood sugar as a person with type 2 diabetes can be a lifelong journey. While taking your medicine, you must routinely check your blood sugar. This helps you to notice how stable or fluctuating your readings may be.

Although diet and exercise may be necessary, speak to your healthcare provider before changing your eating pattern or starting any new exercise regimen to minimize your risk of any side effects. Consider working with a team that includes a registered dietitian (RD) or a registered dietitian nutritionist (RDN), particularly one who is a certified diabetes care and education specialist (CDCES).

CDCES RDs can help you explore your eating, movement, and medication habits, and more. They can help you build your toolkit and capacity to avoid spikes in blood sugar and help you feel better. Navigating blood sugar control and your eating patterns can be challenging, but you don't have to do this alone.

Speak to your healthcare provider about starting a vitamin B12 supplement, especially if you're on this drug long term. Do not start, adjust, or stop taking any medicine, including OTC vitamins, herbs, or supplements without speaking to your medical provider.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

4 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. Xigduo XR label.

  2. Food and Drug Administration. Farxiga label.

  3. Food and Drug Administration. Glucophage label.

  4. Wu Y, Ding Y, Tanaka Y, Zhang W. Risk factors contributing to type 2 diabetes and recent advances in the treatment and preventionInt J Med Sci. 2014;11(11):1185-1200. Published 2014 Sep 6. doi:10.7150/ijms.10001

By Queen Buyalos, PharmD
Queen Buyalos is a pharmacist and freelance medical writer. She takes pride in advocating for cancer prevention, overall health, and mental health education. Queen enjoys counseling and educating patients about drug therapy and translating complex ideas into simple language.