Xigduo XR Side Effects

Generic name: dapagliflozin / metformin

Medically reviewed by Drugs.com. Last updated on Oct 8, 2023.

Note: This document provides detailed information about Xigduo XR Side Effects associated with dapagliflozin / metformin. Some dosage forms listed on this page may not apply specifically to the brand name Xigduo XR.

Applies to dapagliflozin / metformin: oral tablet extended release.

Precautions

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.

Diabetic 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 dapagliflozin / metformin at least 3 days before you have a surgery or other procedures that require fasting.

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.

Serious side effects of Xigduo XR

Along with its needed effects, dapagliflozin / metformin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dapagliflozin / metformin:

Other side effects of Xigduo XR

Some side effects of dapagliflozin / metformin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to dapagliflozin / metformin: oral tablet extended release.

General adverse events

The most common adverse reactions reported with this combination drug included female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache.^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Volume depletion (Including dehydration, hypovolemia, orthostatic hypotension, or hypotension)^[Ref]

Dermatologic

Dapagliflozin:

• Postmarketing reports: Rash

Metformin:

• Uncommon (0.1% to 1%): Angioedema
• Very rare (less than 0.01%): Urticaria, erythema, pruritus^[Ref]

Endocrine

Dapagliflozin:

• Frequency not reported: Small Increase in serum parathyroid hormone levels^[Ref]

Small increases in serum parathyroid hormone (PTH) levels were observed with increases larger in subjects with higher baseline PTH concentrations.^[Ref]

Gastrointestinal

Dapagliflozin-Metformin:

• Common (1% to 10%): Diarrhea, nausea, constipation

Dapagliflozin:

• Uncommon (0.1% to 1%): Constipation, dry mouth

Metformin:

• Very common (10% or more): Nausea, vomiting, diarrhea, abdominal pain, loss of appetite^[Ref]

Genitourinary

• Common (1% to 10%): Escherichia urinary tract infection, female genital mycotic infections (including vulvovaginal mycotic infection, vaginal infection, genital infection, vulvovaginitis, fungal genital infection, vulvovaginal candidiasis, vulval abscess, vulvitis, genital candidiasis, and vaginitis bacterial), urinary tract infections (including urinary tract infection, cystitis, pyelonephritis, urethritis, and prostatitis), male genital mycotic infections (including balanitis, fungal genital infection, penile infection, trigonitis, balanitis candida, genital candidiasis, balanoposthitis, balanoposthitis infective, genital infection, posthitis), nocturia (including pollakiuria, polyuria, and increased urine output), discomfort with urination
• Uncommon (0.1% to 1%): Vulvovaginal pruritus
• Postmarketing reports: Fournier's gangrene, urosepsis, pyelonephritis^[Ref]

Genital mycotic infections have been commonly reported with dapagliflozin treatment. Discontinuation due to genital infection occurred in 0.2% of patients in dapagliflozin clinical trials. Infections were more frequently reported in females than males, and patients with a history of genital mycotic infections were more likely to have an infection than those without a history.

In the 5 years (2013 to 2018) since SGLT2 inhibitor approval, 12 cases of Fournier's gangrene have been reported. Reports were almost equal in adults (men=7; women=5), ages ranged from 38 to 78 years, and the average time to onset after starting an SGLT2 inhibitor was 9.2 months (range 7 days to 25 months).^[Ref]

Hematologic

Dapagliflozin:

• Common (1% to 10): Increased hematocrit

Metformin:

• Very rare (less than 0.01%): Decreased vitamin B12 serum levels^[Ref]

Hepatic

Metformin:

• Very rare (less than 0.01%): Liver function disorders, liver function tests abnormalities, hepatitis
• Postmarketing reports: Cholestatic, hepatocellular, mixed hepatocellular liver injury^[Ref]

Hypersensitivity

Dapagliflozin:

• Uncommon (0.1% to 1%): Serious anaphylactic reactions, severe cutaneous reactions
• Frequency not reported: Hypersensitivity reactions (included urticaria, hypersensitivity)^[Ref]

Immunologic

• Common (1% to 10): Influenza^[Ref]

Metabolic

Dapagliflozin-Metformin:

• Very common (10% or more): Hypoglycemia (when used with sulfonylurea or insulin)
• Common (1% to 10%): Dyslipidemia

Dapagliflozin:

• Common (1% to 10%): Hyperphosphatemia, increases in low-density lipoprotein cholesterol (LDL-C)
• Uncommon (0.1% to 1%): Decreased weight, thirst
• Postmarketing reports: Acidosis including diabetic ketoacidosis, ketoacidosis, or ketosis

Metformin:

• Very rare (less than 0.01%): Lactic acidosis, vitamin B12 deficiency^[Ref]

Hypoglycemia was reported more frequently when this drug was added to sulfonylurea or insulin (up to 43%).

Twenty reports of acidosis have been identified in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database during the period March 2013 through 06 June 2014. All patients required emergency room treatment or hospitalization. These cases were not typical of ketoacidosis or diabetic ketoacidosis (DKA) in that they occurred in patients with type 2 diabetes and their blood sugar levels were only slightly increased. Some factors identified as potentially triggering the acidosis included major illness, reduced food and fluid intake, and reduced insulin dose.^[Ref]

Musculoskeletal

Dapagliflozin-Metformin:

• Common (1% to 10%): Back pain

Dapagliflozin:

• Common (1% to 10%): Pain in extremity^[Ref]

Nervous system

Dapagliflozin-Metformin:

• Common (1% to 10%): Headache, dizziness

Metformin:

• Common (1% to 10%): Taste disturbance^[Ref]

Oncologic

Dapagliflozin:

• Uncommon (0.1% to 1%): Bladder cancer^[Ref]

Newly diagnosed bladder cancer was reported in 10 of 6045 (0.17%) patients receiving dapagliflozin in clinical trials.^[Ref]

Other

• Uncommon (0.1% to 1%): Fungal infection

Renal

Dapagliflozin:

• Uncommon (0.1% to 1%): Increased serum creatinine, increased blood urea
• Frequency not reported: Decreases in eGFR, kidney infection
• Postmarketing reports: Acute kidney injury and impaired renal function^[Ref]

Cases of acute kidney injury have been reported during the postmarketing period with dapagliflozin. Some cases required hospitalization and dialysis; some reports were in patients less than 65 years old.^[Ref]

Respiratory

• Common (1% to 10%): Nasopharyngitis, cough, pharyngitis^[Ref]

See also:

Frequently asked questions

• What are the ingredient drugs contained in Qternmet XR?

Further information

Xigduo XR side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer