Glucovance Side Effects

Please note - some side effects for Glucovance 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 Glucovance - for the consumer

Glucovance

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 Glucovance:

Diarrhea; headache; indigestion; mild stomach pain; nausea; stomach upset; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; confusion; dark urine; dizziness or lightheadedness; fainting; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling or being unwell; low blood sugar symptoms (eg, anxiety, dizziness, fast heartbeat, headache, tremors, unusual sweating); muscle pain or weakness; severe or persistent blurred vision or other vision problems; slow or irregular heartbeat; unusual bruising or bleeding; unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness; yellowing of the eyes or skin.

For the professional

Glucovance

Glucovance

In double-blind clinical trials involving Glucovance as initial therapy or as second-line therapy, a total of 642 patients received Glucovance, 312 received metformin therapy, 324 received glyburide therapy, and 161 received placebo. The percent of patients reporting events and types of adverse events reported in clinical trials of Glucovance (all strengths) as initial therapy and second-line therapy are listed in Table 6.

In a controlled clinical trial of rosiglitazone versus placebo in patients treated with Glucovance (n=365), 181 patients received Glucovance with rosiglitazone and 184 received Glucovance with placebo.

Edema was reported in 7.7% (14/181) of patients treated with rosiglitazone compared to 2.2% (4/184) of patients treated with placebo. A mean weight gain of 3 kg was observed in rosiglitazone-treated patients.

Disulfiram-like reactions have very rarely been reported in patients treated with glyburide tablets.

Hypoglycemia

In controlled clinical trials of Glucovance there were no hypoglycemic episodes requiring medical intervention and/or pharmacologic therapy; all events were managed by the patients. The incidence of reported symptoms of hypoglycemia (such as dizziness, shakiness, sweating, and hunger), in the initial therapy trial of Glucovance are summarized in Table 7. The frequency of hypoglycemic symptoms in patients treated with Glucovance 1.25 mg/250 mg was highest in patients with a baseline HbA1c<7%, lower in those with a baseline HbA1c of between 7% and 8%, and was comparable to placebo and metformin in those with a baseline HbA1c>8%. For patients with a baseline HbA1c between 8% and 11% treated with Glucovance 2.5 mg/500 mg as initial therapy, the frequency of hypoglycemic symptoms was 30 to 35%. As second-line therapy in patients inadequately controlled on sulfonylurea alone, approximately 6.8% of all patients treated with Glucovance experienced hypoglycemic symptoms. When rosiglitazone was added to Glucovance therapy, 22% of patients reported one or more fingerstick glucose measurements ≤50 mg/dL compared to 3.3% of placebo-treated patients. All hypoglycemic events were managed by the patients and only one patient discontinued for hypoglycemia.

Gastrointestinal Reactions

The incidence of GI side effects (diarrhea, nausea/vomiting, and abdominal pain) in the initial therapy trial are summarized in Table 7. Across all Glucovance trials, GI symptoms were the most common adverse events with Glucovance and were more frequent at higher dose levels. In controlled trials, <2% of patients discontinued Glucovance therapy due to GI adverse events.

More resources:

Glucovance

Glucovance

Glucovance

Glucovance - Includes detailed dosage instructions.

Glucovance

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