Janumet XR Side Effects

Generic Name: metformin / sitagliptin

Note: This page contains information about the side effects of metformin / sitagliptin. Some of the dosage forms included on this document may not apply to the brand name Janumet XR.

Not all side effects for Janumet XR may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to metformin / sitagliptin: oral tablet, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by metformin / sitagliptin. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking metformin / sitagliptin:

Less common
  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • fast heartbeat
  • headache
  • increased hunger
  • loss of consciousness
  • mental cloudiness
  • nausea
  • nightmares
  • not thinking clearly
  • seizures
  • shakiness
  • slurred speech
  • unusual tiredness or weakness
Rare
  • Abdominal or stomach discomfort
  • decreased appetite
  • diarrhea
  • fast, shallow breathing
  • general feeling of discomfort
  • muscle pain or cramping
  • shortness of breath
  • sleepiness

Some of the side effects that can occur with metformin / sitagliptin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Bloated
  • excess air or gas in the stomach or intestines
  • fever
  • full feeling
  • indigestion
  • lack or loss of strength
  • muscle aches
  • passing gas
  • sore throat
  • stuffy or runny nose
  • vomiting

For Healthcare Professionals

Applies to metformin / sitagliptin: oral tablet, oral tablet extended release

Metabolic

Metformin-sitagliptin:
Very common (10% or more): Hypoglycemia (13.8% when combined with sulfonylurea; 10.9% when combined with insulin)
Common (1% to 10%): Hypoglycemia, decrease levels of vitamin B12 without clinical manifestations and rarely associated with anemia
Rare (less than 0.1%): Lactic acidosis due to metformin

Sitagliptin:
Uncommon (0.1% to 1%): Hypoglycemia

Metformin:
Common (1% to 10%): Hypoglycemia (5% or more when combined with glyburide)
Uncommon (0.1% to 1%): Hypoglycemia
Very rare (less than 0.01%): Lactic acidosis, vitamin B12 deficiency

The incidence of lactic acidosis has been about 1.5 cases per 10,000 patient years. The risk of lactic acidosis has been particularly high in patients with underlying renal insufficiency and rarely in patients with normal renal function. Concomitant cardiovascular or liver disease, sepsis, and hypoxia have also increased the risk of lactic acidosis.

Signs and symptoms of severe acidosis may include vomiting, abdominal pain, nausea, dyspnea, hypothermia, hypotension, and bradycardia.

Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption. Malabsorption of vitamin B12, due to intrinsic factor deficiency and possibly other mechanisms, in as many as 30% of treated patients, were reported. Megaloblastic anemia has occurred. Decreased levels of vitamin B12 appear to be reversible with discontinuation of metformin or vitamin B12 supplementation.

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, flatulence, vomiting
Uncommon (0.1% to 1%): Constipation, upper abdominal pain, dry mouth
Postmarketing reports: Indigestion, abdominal discomfort, dyspepsia, abdominal pain, acute pancreatitis (including fatal and non-fatal hemorrhagic and necrotizing pancreatitis)

Metformin:
Very common (10% or more): Nausea, vomiting, diarrhea, abdominal pain, loss of appetite

Sitagliptin:
Rare (less than 0.1%): Pancreatitis

Nervous system

Metformin-sitagliptin:
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Somnolence
Frequency not reported: Asthenia

Metformin:
Common (1% to 10%): metallic taste

Respiratory

Common (1% to 10%): Upper respiratory tract infections, nasopharyngitis, pharyngolaryngeal pain, bronchitis, sinusitis, influenza
Postmarketing reports: Interstitial lung disease

Hypersensitivity

Frequency not reported: Hypersensitivity reactions including anaphylaxis

Hepatic

Metformin-sitagliptin:
Postmarketing reports: Hepatic enzyme elevation

Metformin:
Very rare (less than 0.01%): Liver function disorders, hepatitis

Renal

Frequency not reported: Impaired renal function, acute renal failure (sometimes requiring dialysis)

Musculoskeletal

Common (1% to 10%): Arthralgia
Postmarketing reports: Myalgia, pain in extremities, back pain

General

Common (1% to 10%): Peripheral edema

Dermatologic

Postmarketing reports: Angioedema, rash, urticarial, cutaneous vasculitis, exfoliative skin conditions including Steven-Johnson syndrome

Metformin:
Very rare (less than 0.01%): Urticaria, erythema, pruritus

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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