"April 11, 2013 -- A new oral diabetes drug is expected to arrive on pharmacy shelves in the U.S. this week.
Many people predict that Invokana (canagliflozin), approved by the FDA in March, will be a brisk seller. That's partly because i"...
Glucophage, Glucophage XR
Glucophage Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
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. Possible serious side effects of Glucophage include shortness of breath even with mild exertion; swelling or rapid weight gain; fever; chills; body aches; or flu symptoms. Less serious side effects include headache or muscle pain, weakness or mild nausea, vomiting, diarrhea, gas, or stomach pain. This is not a complete list of side effects, and others may occur.
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.
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.
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.
Glucophage 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.
Read the entire detailed patient monograph for Glucophage (Metformin Hcl) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Glucophage Overview - Patient Information: Side Effects
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 Glucophage (Metformin Hcl)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Glucophage FDA Prescribing Information: Side Effects
In a US double-blind clinical study of GLUCOPHAGE in patients with type 2 diabetes, a total of 141 patients received GLUCOPHAGE therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the GLUCOPHAGE patients, and that were more common in GLUCOPHAGE- than placebo-treated patients, are listed in Table 11.
Table 11: Most Common Adverse Reactions ( > 5.0 Percent)
in a Placebo-Controlled Clinical Study of GLUCOPHAGE Monotherapy*
|% of Patients|
|* Reactions that were more common in GLUCOPHAGE- than placebo-treated patients.|
Diarrhea led to discontinuation of study medication in 6% of patients treated with GLUCOPHAGE. Additionally, the following adverse reactions were reported in ≥ 1.0% to ≤ 5.0% of GLUCOPHAGE 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 worldwide clinical trials over 900 patients with type 2 diabetes have been treated with GLUCOPHAGE XR in placebo- and active-controlled studies. In placebo-controlled trials, 781 patients were administered GLUCOPHAGE XR and 195 patients received placebo. 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 12.
Table 12: Most Common Adverse Reactions ( > 5.0 Percent)
in Placebo-Controlled Studies of GLUCOPHAGE XR*
|Adverse Reaction||GLUCOPHAGE XR
|% of Patients|
|* Reactions that were more common in GLUCOPHAGE XR- than placebo-treated patients.|
Diarrhea led to discontinuation of study medication in 0.6% of patients treated with GLUCOPHAGE XR. 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.
In clinical trials with GLUCOPHAGE in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.
Read the entire FDA prescribing information for Glucophage (Metformin Hcl) »
Additional Glucophage, Glucophage XR Information
- Glucophage, Glucophage XR Drug Interactions Center: metformin oral
- Glucophage, Glucophage XR Side Effects Center
- Glucophage, Glucophage XR in detail including Side Effects and Drug Images
- Glucophage, Glucophage XR Overview including Precautions
- Glucophage, Glucophage XR FDA Approved Prescribing Information including Dosage
Glucophage, Glucophage XR - User Reviews
Glucophage, Glucophage XR User Reviews
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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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