Metformin / sitagliptin Side Effects

Some side effects of metformin / sitagliptin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

Along with its needed effects, metformin / sitagliptin 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 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 side effects of metformin / sitagliptin 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:

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

Metabolic side effects have included hypoglycemia and lactic acidosis, which is a potentially fatal metabolic complication. 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. Cases of lactic acidosis occurring in patients with normal renal function have been rarely reported. Concomitant cardiovascular or liver disease, sepsis, and hypoxia have also increased the risk of lactic acidosis.

Lactic acidosis is a medical emergency requiring immediate evaluation and treatment. The case fatality rate may be as high as 50.3%. Patients taking metformin who present with even vague medical illnesses such as myalgia, malaise, somnolence, abdominal discomfort, and so forth, should be evaluated for a metabolic etiology like lactic acidosis.

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

Laboratory evaluation of metformin induced lactic acidosis generally includes determination of the following: blood glucose concentration, lactic acid concentration, serum electrolytes, blood pH, metformin concentration, and exclusion of ketoacidosis.

If lactic acidosis is present, immediate institution of general supportive care is indicated. Prompt hemodialysis is also generally recommended in order to correct the acidosis and remove metformin. Hemodialysis often results in rapid improvement. Some investigators have suggested that dialysis with a bicarbonate buffered dialysate may be particularly effective.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, indigestion, abdominal discomfort, diarrhea, dyspepsia, flatulence, and abdominal pain. Postmarketing experience has included constipation, vomiting, acute pancreatitis, including fatal and nonfatal hemorrhagic and necrotizing pancreatitis.

Nervous system

Nervous system side effects have included asthenia and headache.

Respiratory

Respiratory side effects have included nasopharyngitis.

Hematologic

Hematologic side effects have included malabsorption of vitamin B12, due to intrinsic factor deficiency and possibly other mechanisms, in as many as 30% of treated patients. Megaloblastic anemia has occurred. Discontinuation of metformin or supplementation with vitamin B12 has been necessary.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Postmarketing hypersensitivity reactions have included rash, urticaria, and cutaneous vasculitis.

Hepatic

Hepatic side effects have included postmarketing reports of hepatic enzyme elevations.

Renal

Renal side effects have included postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis.

Musculoskeletal

Arthralgia, myalgia, pain in extremities, and back pain have been reported postmarketing.

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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