Avandamet Side Effects

Please note - some side effects for Avandamet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Avandamet - for the Consumer

Avandamet

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Avandamet:

Cold symptoms; diarrhea; headache; indigestion; mild weight gain; nausea; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; bone pain; chest pain or discomfort; dark urine; dizziness or lightheadedness; fainting; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; muscle pain or weakness; numbness of an arm or leg; pale stools; persistent loss of appetite; red, swollen, blistered, or peeling skin; severe or persistent nausea or vomiting; shortness of breath; slow or irregular heartbeat; sudden severe headache, dizziness, or vomiting; sudden unexplained weight gain; swelling of the hands, ankles, or feet; unusual bone pain; unusual drowsiness; unusual stomach pain or discomfort; unusual tiredness or weakness; yellowing of the eyes or skin.

Avandamet Side Effects - for the Professional

Avandamet

The most common adverse reactions (≥10%) include nausea/vomiting, diarrhea, headache, and dyspepsia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

General

Metformin-rosiglitazone has been generally well tolerated. Viral infection, injury, headache, back pain, fatigue, and arthralgia were reported slightly more frequently than placebo in clinical trials.

Metabolic

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 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 of metformin have included lactic acidosis, which is a potentially fatal metabolic complication of biguanide therapy. The incidence of lactic acidosis has been about 1.5 cases per 10,000 patient years. The incidence may be lower with current recommended doses and less frequent use in the elderly. The risk of lactic acidosis is 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 may also increase the risk of lactic acidosis. Hypoglycemia occurs uncommonly in patients receiving metformin as monotherapy. Strenuous exercise, decreased caloric intake, general debilitation, adrenal insufficiency, pituitary insufficiency, and ethanol use may increase the risk of hypoglycemia. Metabolic side effects of rosiglitazone have included increases in total cholesterol, LDL, and HDL and decreases in free fatty acids. Dose related weight gain has been reported in patients treated with rosiglitazone alone and in combination with other hypoglycemic agents.

Cardiovascular

Cardiovascular side effects of rosiglitazone have included mild to moderate edema. Patients with congestive heart failure have experienced new or worsening edema. Compared to patients receiving placebo, patients with congestive heart failure (CHF) receiving rosiglitazone also experienced more cardiovascular deaths, more CHF worsening, more new or worsening dyspnea, more increases in CHF medication and cardiovascular hospitalization, more myocardial infarctions, and angina.

Healthy volunteers receiving rosiglitazone 8 mg once daily for 8 weeks experienced a statistically significant increase in median plasma volume compared to placebo. Patients with ongoing edema are more likely to have adverse events associated with edema if started on combination therapy with insulin and rosiglitazone.

Dose-related weight gain was seen with rosiglitazone alone and in combination with other hypoglycemic agents. The mechanism is unclear but probably involves a combination of fluid retention and fat accumulation.

In a 26-week study, edema was reported with higher frequency in the rosiglitazone plus insulin combination trials (insulin, 5.4%; and rosiglitazone with insulin 14.7%). Reports of new onset or exacerbation of congestive heart failure occurred at a rate of 1% for insulin alone, and 2% (4 mg) and 3% (8 mg) for insulin in combination with rosiglitazone.

Hematologic

Hematologic side effects have included decreases of previously normal levels of serum vitamin B12 to subnormal levels. Across all controlled clinical studies in adults, decreases in hemoglobin and hematocrit (mean decreases in individual studies of approximately 1.0 gram/dL and 3.3%, respectively) were observed for rosiglitazone maleate alone and in combination with other hypoglycemic agents.

Gastrointestinal

Gastrointestinal side effects have included nausea, anorexia, metallic taste, diarrhea, dyspepsia, flatulence, and abdominal pain. Diarrhea has been reported by 12.7% of patients in clinical trials.

Respiratory

Respiratory side effects have included reports of upper respiratory tract infection in 16% and sinusitis in 6.2% of patients in clinical trials. Patients with congestive heart failure have experienced new or worsening dyspnea.

Hypersensitivity

Hypersensitivity side effects have included rare postmarketing reports of urticaria and angioedema. Postmarketing experience has included rare reports of anaphylactic reactions.

Ocular

Ocular side effects have included changes in accommodation and blurred vision. New onset or worsening (diabetic) macular edema with decreased visual acuity has been reported very rarely in postmarketing experience with rosiglitazone. In some cases, symptoms improved following discontinuation of rosiglitazone. Physicians should consider the possibility of macular edema if a patient reports decreased visual acuity.

Musculoskeletal

Musculoskeletal side effects have included an increased incidence of bone fracture in female patients. The majority of the fractures in the women who received rosiglitazone occurred in the upper arm, hand, and foot. These sites of fracture are different from those usually associated with postmenopausal osteoporosis (e.g., hip or spine). No increase in fracture rates was observed in men treated with rosiglitazone.

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