Glucophage XR Side Effects
Generic name: metformin
Note: This document contains side effect information about metformin. Some of the dosage forms listed on this page may not apply to the brand name Glucophage XR.
Some side effects of Glucophage XR 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: oral solution, oral tablet, oral tablet extended release
Get emergency medical help if you have any of these signs of an allergic reaction while taking metformin (the active ingredient contained in Glucophage XR) hives; difficult breathing; swelling of your face, lips, tongue, or throat.
This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:
muscle pain or weakness;
numb or cold feeling in your arms and legs;
feeling dizzy, light-headed, tired, or very weak;
stomach pain, nausea with vomiting; or
slow or uneven heart rate.
Call your doctor at once if you have any other serious side effect such as:
feeling short of breath, even with mild exertion;
swelling or rapid weight gain; or
fever, chills, body aches, flu symptoms.
Less serious side effects of metformin may include:
headache or muscle pain;
mild nausea, vomiting, diarrhea, gas, stomach pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to metformin: compounding powder, oral solution, oral tablet, oral tablet extended release
Metformin (the active ingredient contained in Glucophage XR) has been generally well tolerated. About 20% of patients experienced mild, transient side effects sometime during therapy.
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 (the active ingredient contained in Glucophage XR) 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.
Metabolic side effects have included 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.
Subnormal vitamin B12 levels have been reported, and may result in anemia or neuropathy. Serum vitamin B12 levels at 2 to 3 year intervals may be useful.
Hypoglycemia occurred uncommonly in patients receiving metformin as monotherapy. Strenuous exercise, decreased caloric intake, general debilitation, adrenal insufficiency, pituitary insufficiency, and ethanol use have increased the risk of hypoglycemia.
Gastrointestinal effects have included nausea, anorexia, metallic taste, diarrhea, dyspepsia, flatulence, and abdominal pain. One study has reported a 20% incidence of diarrhea.
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 (the active ingredient contained in Glucophage XR) or supplementation with vitamin B12 has been necessary.
Other side effects include a single case of leukocytoclastic vasculitis with pneumonitis.
Hepatic side effects have included at least two cases of hepatitis associated with metformin (the active ingredient contained in Glucophage XR) use.
A 52-year-old female with a history of type II diabetes mellitus and hypertension developed lethargy, fatigue, and diarrhea after taking metformin for more than 2 weeks. After continuing metformin for a total of four weeks, her sclera became icteric and she was hospitalized. Aside from a soft systolic ejection fracture and a moderate degree of bilateral lower extremity edema, her physical examination was unremarkable. Laboratory data showed grossly elevated total bilirubin, AST, ALT, and alkaline phosphatase. Several days after her initial presentation all of her medications were discontinued. Her signs and symptoms significantly improved over the following several days, and she was discharged within two weeks of her hospitalization. The patient's presentation was considered consistent with drug-induced toxicity attributed to metformin.
Other side effects have included reports of a distinct drug odor. The odor is generally described as "fish or fishy". The odor report varies considerably between generic versions and seems to be less noticeable with film-coated formulations.
More Glucophage XR resources
- Glucophage XR Advanced Consumer (Micromedex) - Includes Dosage Information
- Glucophage XR Prescribing Information (FDA)
- Glucophage XR extended-release tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Fortamet Prescribing Information (FDA)
- Glucophage Consumer Overview
- Glucophage MedFacts Consumer Leaflet (Wolters Kluwer)
- Glucophage Prescribing Information (FDA)
- Glumetza Prescribing Information (FDA)
- Metformin Prescribing Information (FDA)
- Metformin Hydrochloride Monograph (AHFS DI)
- Riomet Prescribing Information (FDA)
- Riomet Consumer Overview
- Riomet solution MedFacts Consumer Leaflet (Wolters Kluwer)
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