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Xigduo
Dapagliflozin and Metformin
$285.00
5mg/850mg · 3 × 60 tablets · 3 months supply
GenericGeneric medicine
$95.00 per month
Strength
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Annual cost
$1140a year at this pack size
Prescription required
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5mg/850mg
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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
Overview
Xigduo is a prescription medicine 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. Dapagliflozin helps the kidneys remove glucose through urine, while metformin reduces the glucose made by the liver and helps the body use insulin more effectively.
What it treats
• Type 2 diabetes in adults and children aged 10 years and older, to improve blood sugar control alongside diet and exercise. • Chronic kidney disease at risk of progression in adults with type 2 diabetes: the dapagliflozin component reduces the risk of sustained kidney function decline, end-stage kidney disease, cardiovascular death and hospitalization for heart failure. • Heart failure in adults with type 2 diabetes: the dapagliflozin component reduces the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits. • In adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors: the dapagliflozin component reduces the risk of hospitalization for heart failure.
Safety information
Side effects
Common side effects include genital yeast infections in women, nose and throat inflammation, urinary tract infections, diarrhoea and headache. Nausea and vomiting are also common side effects reported with metformin. Serious side effects include lactic acidosis (a build-up of lactic acid in the blood), ketoacidosis, dehydration, severe urinary infections involving the kidneys or bloodstream, and Fournier’s gangrene, a serious infection of tissue around the genitals and the area between the genitals and anus. Seek urgent medical attention if ketoacidosis is suspected, even if blood glucose is not high. Pain, tenderness, redness or swelling around the genitals or the area between the genitals and anus, together with fever or feeling unwell, also requires urgent medical attention. Contact your doctor promptly for signs of urinary or genital infection or dehydration. Low blood sugar can occur when this medicine is used with insulin or medicines that stimulate insulin release. Metformin can also lower vitamin B12 levels; the label recommends annual blood tests to monitor blood cell measures.
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 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 ever had a serious allergic reaction to dapagliflozin, metformin or any other ingredient. Serious reactions can include anaphylaxis and angioedema. Use should be avoided in people with liver impairment. Xigduo may pose a risk to an unborn baby, especially during the second and third trimesters, and is not recommended while breastfeeding. Women who have not reached menopause should be advised of the potential for an unintended pregnancy. Important precautions include lactic acidosis and ketoacidosis. Ketoacidosis must be assessed regardless of blood glucose levels. If it is suspected, Xigduo should be stopped and should not be restarted until the condition has resolved. Older adults, people with kidney impairment or low blood pressure, and those taking diuretics need assessment for fluid depletion before treatment and monitoring during treatment. Older adults need more frequent kidney function checks and have a higher risk of low blood pressure. Urinary and genital infections can occur, including serious infections. Seek immediate medical assessment for pain, tenderness, redness or swelling around the genitals or the area between the genitals and anus, together with fever or feeling unwell. Taking Xigduo with insulin or medicines that stimulate insulin release increases the risk of low blood sugar; the prescriber may need to adjust those medicines. Metformin may lower vitamin B12 levels, and annual blood tests are recommended.
Interactions
Topiramate, zonisamide, acetazolamide and dichlorphenamide may increase the risk of lactic acidosis (a build-up of lactic acid in the blood) when taken with Xigduo. More frequent monitoring may be needed. Ranolazine, vandetanib, dolutegravir and cimetidine can slow the removal of metformin from the body and may also increase this risk. Avoid excessive alcohol intake, as alcohol increases metformin’s effect on how the body processes lactic acid. Insulin and medicines that increase insulin release, such as sulfonylureas, can increase the risk of low blood sugar when used with Xigduo. 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 may be needed when these medicines are started or stopped. Xigduo may lower lithium levels in the blood. If you take lithium, more frequent blood tests may be needed when Xigduo is started or its prescribed dose changes. Xigduo causes glucose to appear in urine, so urine glucose tests should not be used to monitor blood sugar control. The 1,5-anhydroglucitol (1,5-AG) test is also unreliable during treatment; other monitoring methods should be used.
Using Xigduo
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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