Glyburide And Metformin Side Effects

Please note - some side effects for Glyburide And Metformin 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).

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Glyburide and Metformin

Glyburide and Metformin Hydrochloride

In double-blind clinical trials involving Glyburide and Metformin Hydrochloride as initial therapy or as second-line therapy, a total of 642 patients received the combination product Glyburide and Metformin Hydrochloride, 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 Glyburide and Metformin Hydrochloride (all strengths) as initial therapy and second-line therapy are listed in Table 5.

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

Hypoglycemia

In controlled clinical trials of Glyburide and Metformin Hydrochloride 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 Glyburide and Metformin Hydrochloride are summarized in Table 6. The frequency of hypoglycemic symptoms in patients treated with Glyburide and Metformin Hydrochloride 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 Glyburide and Metformin Hydrochloride 2.5 mg/500 mg as initial therapy, the frequency of hypoglycemic symptoms was 30-35%. As second-line therapy in patients inadequately controlled on sulfonylurea alone, approximately 6.8% of all patients treated with Glyburide and Metformin Hydrochloride experienced hypoglycemic symptoms.

The incidence of GI side effects (diarrhea, nausea/vomiting, and abdominal pain) in the initial therapy trial are summarized in Table 6. Across all Glyburide and Metformin Hydrochloride trials, GI symptoms were the most common adverse events with Glyburide and Metformin Hydrochloride and were more frequent at higher dose levels. In controlled trials, <2% of patients discontinued Glyburide and Metformin Hydrochloride therapy due to GI adverse events.

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