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Glumetza

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Glumetza

Glumetza Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Glumetza (metformin hydrochloride) is for people with type 2 (non-insulin-dependent) diabetes. It is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes. Glumetza is an oral diabetes medicine. This medication is available in generic form. Common side effects include nausea, vomiting, stomach upset, diarrhea, weakness, or a metallic taste in the mouth.

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, non-steroidal 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 breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Glumetza in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Glumetza Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, stomach upset, diarrhea, weakness, or a metallic taste in the mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after taking the same dose for several days or weeks), tell your doctor immediately. Stomach symptoms that occur after the first days of your treatment may be signs of lactic acidosis.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Metformin does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if this drug is prescribed with other anti-diabetic medications. Talk with your doctor or pharmacist about whether the dose of your other diabetic medication(s) needs to be lowered.

Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction immediately. Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your doctor may need to adjust your diabetes medication(s).

Stop taking this medication and tell your doctor right away if this very serious side effect occurs: lactic acidosis (see Warning section).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Glumetza (Metformin Hcl)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Glumetza FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

In the 24-week active-controlled monotherapy trial, serious adverse events were reported in 3.6% (19/528) of the GLUMETZA (metformin hcl) -treated patients compared to 2.9% (5/174) of the patients treated with immediate-release metformin. During the 6-month open-label, uncontrolled, extension trial, an additional 10 (4.0%) GLUMETZA (metformin hcl) -treated patients reported a serious adverse event. In the add-on to sulfonylurea study, a serious adverse event was reported in 2.1% (9/431) of the GLUMETZA (metformin hcl) +glyburide treated patients compared to 1.4% (2/144) of the placebo+glyburide treated patients. When the data from all clinical trials were combined, the most frequently (incidence ≥ 0.5 %) reported serious adverse events classified by system organ class were gastrointestinal disorders (1.0% of GLUMETZA (metformin hcl) -treated patients compared to 0% of patients not treated with GLUMETZA (metformin hcl) ) and cardiac disorders (0.4% of GLUMETZA (metformin hcl) -treated patients compared to 0.5% of patients not treated with GLUMETZA (metformin hcl) ). Only 2 serious adverse events (unstable angina [n=2] and pancreatitis [n=2]) were reported in more than one GLUMETZA (metformin hcl) -treated patient.

In the placebo-controlled study, patients receiving background glyburide (SU; sulfonylurea) therapy were randomized to receive add-on treatment of either one of three different regimens of GLUMETZA (metformin hcl) or placebo. In total, 431 patients received GLUMETZA (metformin hcl) + SU and 144 patients placebo + SU. Adverse events reported in greater than 5% of patients treated with GLUMETZA (metformin hcl) that were more common in the combined GLUMETZA (metformin hcl) + SU group than in the placebo + SU group are shown in Table 5. In 0.7% of patients treated with GLUMETZA (metformin hcl) + SU, diarrhea was responsible for discontinuation of study medication compared to zero in the placebo + SU group.

Table 5 : Treatment-Emergent Adverse Events Reported By > 5% * of Patients for the Combined GLUMETZA (metformin hcl) Group Versus Placebo Group

Adverse Event
(MedDRA Preferred Term)
GLUMETZA + SU
(n = 431)
Placebo + SU
(n = 144)
Hypoglycemia NOS 13.7% 4.9%
Diarrhea 12.5% 5.6%
Nausea 6.7% 4.2%
*AE's that were more common in the GLUMETZA-treated than in the placebo-treated patients.

In the same study, the following adverse events were reported by 1-5% of patients for the combined GLUMETZA (metformin hcl) + SU group and these events occurred more commonly in the GLUMETZA (metformin hcl) -treated than in the placebo-treated patients:

Ear and labyrinth disorders: ear pain

Gastrointestinal disorders: vomiting NOS, dyspepsia, flatulence, abdominal pain upper, abdominal distension, abdominal pain NOS, toothache, loose stools

General disorders and administration site conditions: asthenia, chest pain

Immune system disorders: seasonal allergy

Infections and infestations: gastroenteritis viral NOS, tooth abscess, tonsillitis, fungal infection NOS

Injury, poisoning and procedural complications: muscle strain

Musculoskeletal and connective tissue disorders: pain in limb, myalgia, muscle cramp

Nervous system disorders: dizziness, tremor, sinus headache, hypoaesthesia

Respiratory, thoracic and mediastinal disorders: nasal congestion

Skin and subcutaneous tissue disorders: contusion

Vascular disorders: hypertension NOS

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

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Glumetza - User Reviews

Glumetza User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Glumetza sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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