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Xigduo XR
Dapagliflozin and Metformin
$342.00
5/1000mg · 3 × 56 tablets · 6 months supply
BrandBranded medicine· By Astra Zeneca
$57.00 per month
Strength
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Annual cost
$798a year at this pack size
Prescription required
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5/1000mg
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FDA boxed warningLactic acidosis
- Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by non‑specific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.
- Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, hepatic impairment and mitochondrial diseases.
- Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the full prescribing information.
- If metformin-associated lactic acidosis is suspected, immediately discontinue XIGDUO XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.
If lactic acidosis is suspected, discontinue XIGDUO XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
About Xigduo XR
Overview
Xigduo XR is an extended-release tablet containing dapagliflozin and metformin hydrochloride. It is used alongside diet and exercise to improve blood sugar control in adults and children aged 10 years and older with type 2 diabetes. In adults with type 2 diabetes and certain kidney or heart conditions, its dapagliflozin component is also indicated to reduce specific risks related to kidney disease progression or heart failure. It works by helping the kidneys remove more sugar through urine, reducing sugar production by the liver and absorption from the gut, and helping the body use insulin more effectively.
What it treats
• Type 2 diabetes in adults and children aged 10 years and older, alongside diet and exercise, to improve blood sugar control. In adults with type 2 diabetes, the dapagliflozin component is also used for: • Chronic kidney disease at risk of worsening: to reduce the risk of sustained kidney function decline, end-stage kidney disease, cardiovascular death and hospital admission for heart failure. • Heart failure: to reduce the risk of cardiovascular death, hospital admission for heart failure and urgent heart failure visits. • Established cardiovascular disease or multiple cardiovascular risk factors: to reduce the risk of hospital admission for heart failure.
Safety information
Side effects
Common side effects include vaginal yeast infections, cold-like symptoms, urinary tract infections, diarrhea and headache. Nausea and vomiting are also common side effects of the metformin component. Serious side effects include lactic acidosis (a buildup of lactic acid), ketoacidosis (a buildup of acids called ketones), dehydration, and serious urinary or genital infections, including kidney infections and infections that spread to the bloodstream. Ketoacidosis can occur even when blood sugar is not high. Low blood sugar can occur when Xigduo XR is used with insulin or medicines that stimulate insulin release. Metformin may also lower vitamin B12 levels. Contact a doctor promptly if you suspect a serious side effect. Seek immediate medical attention for pain, tenderness, redness or swelling around the genitals or the area between the genitals and anus, together with fever or feeling unwell. These may be signs of Fournier’s gangrene, a serious infection that destroys tissue and requires urgent treatment.
FDA boxed warning
Lactic acidosis
- Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by non‑specific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.
- Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, hepatic impairment and mitochondrial diseases.
- Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the full prescribing information.
- If metformin-associated lactic acidosis is suspected, immediately discontinue XIGDUO XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.
If lactic acidosis is suspected, discontinue XIGDUO XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not take Xigduo XR if you have severe kidney impairment (eGFR below 30 mL/min/1.73 m²), end-stage kidney disease, or acute or chronic metabolic acidosis, including diabetic ketoacidosis. Do not take it if you have had a serious allergic reaction to dapagliflozin, metformin hydrochloride or any other ingredient. Avoid use if you have liver impairment. Xigduo XR carries warnings for lactic acidosis and ketoacidosis. Ketoacidosis must be assessed regardless of blood glucose levels. If it is suspected, Xigduo XR should be stopped and should not be restarted until the condition has resolved. Extra caution is needed in older adults and people with kidney impairment, low blood pressure or those taking diuretics, because of fluid loss and low blood pressure risks. Fluid status should be assessed and corrected before treatment. Older adults need more frequent kidney function checks. Urinary and genital infections require prompt assessment and treatment. Seek immediate medical attention for pain, tenderness, redness or swelling around the genitals or the area between the genitals and anus, together with fever or feeling unwell. These may indicate a serious infection called Fournier’s gangrene. Taking Xigduo XR with insulin or medicines that stimulate insulin release increases the risk of low blood sugar. Metformin may lower vitamin B12 levels; blood counts should be checked annually. There is a potential risk to the fetus during pregnancy, especially in the second and third trimesters. Xigduo XR is not recommended while breastfeeding. Women who have not reached menopause should be aware of the potential for unintended pregnancy.
Interactions
Topiramate, zonisamide, acetazolamide and dichlorphenamide may increase the risk of lactic acidosis (a buildup of lactic acid in the blood) when taken with Xigduo XR. More frequent monitoring may be needed. Ranolazine, vandetanib, dolutegravir and cimetidine can reduce the removal of metformin from the body, which may also increase this risk. Avoid excessive alcohol intake while taking Xigduo XR. Alcohol can increase metformin’s effect on how the body processes lactate. Insulin and medicines that stimulate insulin release, such as sulfonylureas, can increase the risk of low blood sugar when used with Xigduo XR. Your prescriber may need to adjust these medicines. Some medicines can raise blood sugar and make it harder to control. These include thiazides and other diuretics, corticosteroids, phenothiazines, thyroid medicines, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers and isoniazid. Closer blood sugar monitoring is needed when these medicines are started or stopped. Xigduo XR may lower lithium levels in the blood. If you take lithium, levels should be checked more frequently when Xigduo XR is started or its prescribed dose changes. Tell your doctor that you take Xigduo XR before tests used to assess blood sugar control. It causes positive urine glucose tests and makes the 1,5-anhydroglucitol (1,5-AG) test unreliable for this purpose. Other monitoring methods should be used.
Using Xigduo XR
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label XIGDUO XR (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] (DailyMed, retrieved 19 September 2026).
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