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Glumetza

Last reviewed on RxList: 5/27/2016
Glumetza Side Effects Center

Last reviewed on RxList 11/11/2016

Glumetza (metformin hydrochloride) is an oral diabetes medicine for people with type 2 (non-insulin-dependent) diabetes. Glumetza is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes. Glumetza is available in generic form. Common side effects of Glumetza include:

  • nausea,
  • vomiting,
  • stomach upset or pain,
  • gas,
  • diarrhea,
  • weakness,
  • headache,
  • muscle pain, or
  • a metallic taste in the mouth.

An empty Glumetza tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication. Low blood sugar may occur if Glumetza is prescribed with other anti-diabetic medications. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet.

Glumetza should be taken once daily. Dosage is individualized based on effectiveness and tolerance. The maximum recommended daily dose is 2000 mg. Hyperglycemia (high blood sugar) may result if you take Glumetza with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, and diet pills, or medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if you take Glumetza with drugs that lower blood sugar, such as: alcohol, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, or probenecid. It may also interact with furosemide, nifedipine, cimetidine or ranitidine, amiloride or triamterene, digoxin, morphine, procainamide, quinidine, trimethoprim, or vancomycin. During pregnancy, Glumetza should be used only when prescribed. Your doctor may direct you to use insulin instead of this product during your pregnancy. This medication can cause changes in the menstrual cycle (promote ovulation) and increase the risk of becoming pregnant. Consult your doctor about the use of reliable birth control. This medication passes into breast milk in small amounts. Consult your doctor before breastfeeding.

Our Glumetza (metformin hydrochloride) 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.

Glumetza Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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;
  • trouble breathing;
  • 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 may include:

  • headache or muscle pain;
  • weakness; or
  • 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. You may report side effects to FDA at 1-800-FDA-1088.

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

Glumetza Professional Information

SIDE EFFECTS

Clinical Trials 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 clinical practice.

In clinical trials conducted in the U.S., over 1000 patients with type 2 diabetes mellitus have been treated with GLUMETZA 1500-2000 mg/day in active-controlled and placebo-controlled studies with the 500 mg dosage form.

In the 24-week monotherapy trial comparing GLUMETZA to immediate-release metformin, serious adverse reactions were reported in 3.6% (19/528) of the GLUMETZA-treated patients compared to 2.9% (5/174) of the patients treated with immediate-release metformin. In the add-on to sulfonylurea study, patients receiving background glyburide therapy were randomized to receive add-on treatment of either one of three different regimens of GLUMETZA or placebo. In total, 431 patients received GLUMETZA and glyburide and 144 patients received placebo and glyburide. A serious adverse reaction was reported in 2.1% (9/431) of the GLUMETZA and glyburide-treated patients compared to 1.4% (2/144) of the placebo and glyburide-treated patients. When the data from the monotherapy and add-on to sulfonylurea clinical trials were combined, the most frequently (incidence ≥ 0.5 %) reported serious adverse reactions classified by system organ class were gastrointestinal disorders (1.0% of GLUMETZA-treated patients compared to 0% of patients not treated with GLUMETZA) and cardiac disorders (0.4% of GLUMETZA-treated patients compared to 0.5% of patients not treated with GLUMETZA). Only 2 serious adverse reactions (unstable angina [n=2] and pancreatitis [n=2]) were reported in more than one GLUMETZA-treated patient.

Adverse reactions reported in greater than 5% of patients treated with GLUMETZA that were more common in the combined GLUMETZA and glyburide group than in the placebo and glyburide group are shown in Table 1.

In 0.7% of patients treated with GLUMETZA and glyburide, diarrhea was responsible for discontinuation of study medication compared to no patients in the placebo and glyburide group.

Table 1: Treatment-Emergent Adverse Reactions Reported By >5H* of Patients for the Combined GLUMETZA Groups Venus Placebo Group

Adverse Reaction GLUMETZA + Ghburide
(n =431)
Placebo + Glyburide
(n = 144)
Hypoglycemia 13.7% 4.9%
Dianhea 12.5% 5.6%
Nausea 6.7% 4.2%
* ARs that were more common in the GLUMETZA-treated than in the placebo- treated patients

Laboratory Tests

Vitamin B12 concentrations

Metformin may lower serum vitamin B12 concentrations. Measurement of hematologic parameters on an annual basis is advised in patients on GLUMETZA and any apparent abnormalities should be appropriately investigated and managed. (See WARNINGS AND PRECAUTIONS)

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

Related Resources for Glumetza

Read the Glumetza User Reviews »

© Glumetza Patient Information is supplied by Cerner Multum, Inc. and Glumetza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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