Glipizide and metformin Side Effects

Please note - some side effects for Glipizide 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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Glipizide and Metformin

Glipizide and Metformin Hydrochloride Tablets

In a double-blind 24 week clinical trial involving Glipizide and Metformin hydrochloride tablets as initial therapy, a total of 172 patients received Glipizide and Metformin hydrochloride tablets, 2.5 mg/250 mg, 173 received Glipizide and Metformin hydrochloride tablets, 2.5 mg/500 mg, 170 received glipizide, and 177 received metformin. The most common clinical adverse events in these treatment groups are listed in Table 4.

In a double-blind 18 week clinical trial involving Glipizide and Metformin hydrochloride tablets as second-line therapy, a total of 87 patients received Glipizide and Metformin hydrochloride tablets, 84 received glipizide, and 75 received metformin. The most common clinical adverse events in this clinical trial are listed in Table 5.

In a controlled initial therapy trial of Glipizide and Metformin hydrochloride tablets, 2.5 mg/250 mg and 2.5 mg/500 mg the numbers of patients with hypoglycemia documented by symptoms (such as dizziness, shakiness, sweating, and hunger) and a fingerstick blood glucose measurement ≤ 50 mg/dL were 5 (2.9%) for glipizide, 0 (0%) for metformin, 13 (7.6%) for Glipizide and Metformin hydrochloride tablets, 2.5 mg/250 mg, and 16 (9.3%) for Glipizide and Metformin hydrochloride tablets, 2.5 mg/500 mg. Among patients taking either Glipizide and Metformin hydrochloride tablets, 2.5 mg/250 mg or Glipizide and Metformin hydrochloride tablets, 2.5 mg/500 mg, nine (2.6%) patients discontinued Glipizide and Metformin hydrochloride tablets due to hypoglycemic symptoms and one required medical intervention due to hypoglycemia. In a controlled second-line therapy trial of Glipizide and Metformin hydrochloride tablets, 5 mg/500 mg, the numbers of patients with hypoglycemia documented by symptoms and a fingerstick blood glucose measurement ≤ 50 mg/dL were 0 (0%) for glipizide, 1 (1.3%) for metformin, and 11 (12.6%) for Glipizide and Metformin hydrochloride tablets. One (1.1%) patient discontinued Glipizide and Metformin hydrochloride tablet therapy due to hypoglycemic symptoms and none required medical intervention due to hypoglycemia.

Among the most common clinical adverse events in the initial therapy trial were diarrhea and nausea/vomiting; the incidences of these events were lower with both Glipizide and Metformin hydrochloride tablets dosage strengths than with metformin therapy. There were 4 (1.2%) patients in the initial therapy trial who discontinued Glipizide and Metformin hydrochloride tablet therapy due to GI adverse events. Gastrointestinal symptoms of diarrhea, nausea/vomiting, and abdominal pain were comparable among Glipizide and Metformin hydrochloride tablets, Glipizide and Metformin in the second-line therapy trial. There were 4 (4.6%) patients in the second-line therapy trial who discontinued Glipizide and Metformin hydrochloride tablet therapy due to GI adverse events.

Glipizide and Metformin Tablets

Glipizide and Metformin Hydrochloride Tablets

In a double-blind 24-week clinical trial involving Glipizide and Metformin hydrochloride tablets as initial therapy, a total of 172 patients received Glipizide and Metformin hydrochloride 2.5 mg/250 mg, 173 received Glipizide and Metformin hydrochloride 2.5 mg/500 mg, 170 received glipizide, and 177 received metformin. The most common clinical adverse events in these treatment groups are listed in Table 4.

In a double-blind 18-week clinical trial involving Glipizide and Metformin hydrochloride tablets as second-line therapy, a total of 87 patients received Glipizide and Metformin hydrochloride, 84 received glipizide, and 75 received metformin. The most common clinical adverse events in this clinical trial are listed in Table 5.

Hypoglycemia

In a controlled initial therapy trial of Glipizide and Metformin hydrochloride 2.5 mg/250 mg and 2.5 mg/500 mg the numbers of patients with hypoglycemia documented by symptoms (such as dizziness, shakiness, sweating, and hunger) and a fingerstick blood glucose measurement ≤ 50 mg/dL were 5 (2.9%) for glipizide, 0 (0%) for metformin, 13 (7.6%) for Glipizide and Metformin hydrochloride 2.5 mg/250 mg, and 16 (9.3%) for Glipizide and Metformin hydrochloride 2.5 mg/500 mg. Among patients taking either Glipizide and Metformin hydrochloride 2.5 mg/250 mg or Glipizide and Metformin hydrochloride 2.5 mg/500 mg, nine (2.6%) patients discontinued Glipizide and Metformin hydrochloride tablets due to hypoglycemic symptoms and one required medical intervention due to hypoglycemia. In a controlled second-line therapy trial of Glipizide and Metformin hydrochloride 5 mg/500 mg, the numbers of patients with hypoglycemia documented by symptoms and a fingerstick blood glucose measurement ≤ 50 mg/dL were 0 (0%) for glipizide, 1 (1.3%) for metformin, and 11 (12.6%) for Glipizide and Metformin hydrochloride. One (1.1%) patient discontinued Glipizide and Metformin hydrochloride therapy due to hypoglycemic symptoms and none required medical intervention due to hypoglycemia.

Gastrointestinal Reactions

Among the most common clinical adverse events in the initial therapy trial were diarrhea and nausea/vomiting; the incidences of these events were lower with both Glipizide and Metformin hydrochloride dosage strengths than with metformin therapy. There were 4 (1.2%) patients in the initial therapy trial who discontinued Glipizide and Metformin hydrochloride therapy due to GI adverse events. Gastrointestinal symptoms of diarrhea, nausea/vomiting, and abdominal pain were comparable among Glipizide and Metformin hydrochloride, glipizide, and metformin in the second-line therapy trial. There were 4 (4.6%) patients in the second-line therapy trial who discontinued Glipizide and Metformin hydrochloride therapy due to GI adverse events.

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