Slideshows Images Quizzes

Glucophage

Last reviewed on RxList: 6/22/2018
Glucophage Side Effects Center

Last reviewed on RxList 6/22/2018

Glucophage and Glucophage XR (metformin hydrochloride) are oral antihyperglycemic drugs used to treat type 2 diabetes. Glucophage is available as tablets while Glucophage XR is available as extended-release tablets. Common side effects include:

Contact your doctor if you experience serious side effects of Glucophage including shortness of breath, swelling or rapid weight gain, fever or chills, flu symptoms, body aches, muscle pain or weakness, numb or cold feeling in your arms or legs, trouble breathing, dizziness, or slow or irregular heart rate.

Glucophage should be given in divided doses with meals while Glucophage XR should generally be given once daily with the evening meal. Glucophage or Glucophage XR should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. Glucophage should not be given to a child younger than 10 years old. Glucophage XR should not be given to a child younger than 17 years old. The FDA classifies Glucophage as a class-B drug during pregnancy, which means that there have not been enough studies to determine the safety of its use in pregnant women, so Glucophage and Glucophage XR should not be used during pregnancy unless clearly needed. Safety studies have also not been conducted in nursing mothers. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Glucophage and Glucophage XR may interact with furosemide, nifedipine, cimetidine, ranitidine, amiloride, triamterene, digoxin, morphine, procainamide, quinidine, quinine, trimethoprim, vancomycin, isoniazid, diuretics (water pills), steroids, heart or blood pressure medications, niacins, phenothiazines, thyroid medicines, birth control pills and other hormones, seizure medicines, and diet pills or medicines to treat asthma, colds or allergies. Tell your doctor all medications and supplements you use.

Our Glucophage and Glucophage XR Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Glucophage Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • slow or uneven heart rate.

Common side effects may include:

  • low blood sugar;
  • nausea, upset stomach; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Glucophage (Metformin Hcl)

Glucophage Professional Information

SIDE EFFECTS

The following adverse reactions are also discussed elsewhere in the labeling:

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Glucophage

In a U.S. clinical trial of GLUCOPHAGE in patients with type 2 diabetes mellitus, a total of 141 patients received GLUCOPHAGE up to 2550 mg per day. Adverse reactions reported in greater than 5% of GLUCOPHAGE treated patients and that were more common than in placebo-treated patients, are listed in Table 1.

Table 1: Adverse Reactions from a Clinical Trial of GLUCOPHAGE Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus

  GLUCOPHAGE
(n=141)
Placebo
(n=145)
Diarrhea 53% 12%
Nausea/Vomiting 26% 8%
Flatulence 12% 6%
Asthenia 9% 6%
Indigestion 7% 4%
Abdominal Discomfort 6% 5%
Headache 6% 5%

Diarrhea led to discontinuation of GLUCOPHAGE in 6% of patients. Additionally, the following adverse reactions were reported in ≥1% to ≤5% of GLUCOPHAGE treated patients and were more commonly reported with GLUCOPHAGE than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.

In GLUCOPHAGE clinical trials of 29-week duration, a decrease to subnormal levels of previously normal serum vitamin B12 levels was observed in approximately 7% of patients.

Pediatric Patients

In clinical trials with GLUCOPHAGE in pediatric patients with type 2 diabetes mellitus, the profile of adverse reactions was similar to that observed in adults.

Glucopage XR

In placebo-controlled trials, 781 patients were administered GLUCOPHAGE XR. Adverse reactions reported in greater than 5% of the GLUCOPHAGE XR patients, and that were more common in GLUCOPHAGE XR-than placebo-treated patients, are listed in Table 2.

Table 2: Adverse Reactions from Clinical Trials of GLUCOPHAGE XR Occurring >5% and More Common than Placebo in Patients with Type 2 Diabetes Mellitus

  GLUCOPHAGE XR
(n=781)
Placebo
(n=195)
Diarrhea 10% 3%
Nausea/Vomiting 7% 2%

Diarrhea led to discontinuation of GLUCOPHAGE XR in 0.6% of patients. Additionally, the following adverse reactions were reported in ≥1.0% to ≤5.0% of GLUCOPHAGE XR patients and were more commonly reported with GLUCOPHAGE XR than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of metformin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.

Read the entire FDA prescribing information for Glucophage (Metformin Hcl)

Related Resources for Glucophage
CONTINUE SCROLLING FOR RELATED ARTICLE