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Janumet XR
Sitagliptin and Metformin
$435.00
50mg/500mg · 3 × 60 tablets · 6 months supply
BrandBranded medicine· By MSD
$72.50 per month
Strength
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Annual cost
$870a year at this pack size
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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 nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), 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 JANUMET 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 JANUMET XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
About Janumet XR
Overview
Janumet XR is a prescription extended-release tablet containing sitagliptin and metformin hydrochloride. It is used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes. It works by combining two medicines that lower blood sugar. It is not for treating type 1 diabetes.
What it treats
Janumet XR is used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes. It is not for treating type 1 diabetes.
Safety information
Side effects
Common side effects include diarrhea, upper respiratory tract infection and headache. Serious side effects include lactic acidosis, inflammation of the pancreas (pancreatitis), acute kidney failure that may require dialysis, serious allergic reactions, severe skin reactions and severe, disabling joint pain. Pancreatitis can be fatal. Contact a doctor immediately if pancreatitis or a serious allergic or skin reaction is suspected; Janumet XR should be stopped promptly in these cases. Report any skin blisters or sores to a doctor, as these may indicate bullous pemphigoid, a serious skin condition that may require hospitalization. Janumet XR should be stopped if this condition is suspected. Low blood sugar is more likely when Janumet XR is used with insulin or medicines that stimulate insulin release. Metformin may also lower vitamin B12 levels. Kidney function, blood counts and vitamin B12 levels need monitoring. Heart failure has been observed with two other medicines in the same class as sitagliptin. Patients with risk factors for heart failure need assessment and monitoring for signs and symptoms.
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 nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), 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 JANUMET 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 JANUMET 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 Janumet XR if you have severe kidney impairment (eGFR below 30 mL/min/1.73 m²), acute or chronic metabolic acidosis, including diabetic ketoacidosis, or a history of a serious allergic reaction to Janumet XR, sitagliptin or metformin. Serious allergic reactions include anaphylaxis and angioedema (swelling beneath the skin). Use should be avoided in people with liver impairment. Warnings include lactic acidosis, pancreatitis and acute kidney failure. Kidney function should be checked before treatment and at least annually, with more frequent checks in older adults. If you have risk factors for heart failure, your prescriber should weigh the risks and benefits and monitor for symptoms; heart failure has been observed with two other medicines in the same class as sitagliptin. Taking Janumet XR with insulin or medicines that stimulate insulin release increases the risk of low blood sugar. Metformin may lower vitamin B12 levels, so blood counts and vitamin B12 need periodic monitoring. Janumet XR should be stopped promptly if pancreatitis or a serious allergic reaction is suspected. Severe, disabling joint pain and blistering skin disease have also been reported with medicines in sitagliptin’s class. Report severe joint pain, blisters or open skin sores to your prescriber; treatment may need to be stopped. Premenopausal women should be advised of the potential for unintended pregnancy.
Interactions
Some medicines can increase the risk of lactic acidosis, a buildup of lactic acid in the blood, when taken with Janumet XR. Tell your doctor if you take: • Topiramate, zonisamide, acetazolamide or dichlorphenamide, which can affect the body’s acid balance. More frequent monitoring may be needed. • Ranolazine, vandetanib, dolutegravir or cimetidine, which can slow the removal of metformin from the body. Your doctor should review the benefits and risks of using these together. Alcohol can increase metformin’s effect on lactic acid metabolism. Avoid excessive alcohol intake and discuss alcohol use with your doctor. Insulin and medicines that stimulate insulin release, such as sulfonylureas, can increase the risk of low blood sugar when used with Janumet XR. Your prescriber may need to adjust those 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 starting these medicines and when stopping them, as stopping them may lead to low blood sugar.
Using Janumet 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 JANUMET XR (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MERCK SHARP & DOHME LLC] (DailyMed, retrieved 19 September 2026).
Patient information and references
Official and supporting information to read alongside advice from your prescriber or pharmacist.
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