Glucotrol Side Effects

Generic name: glipizide

Note: This document contains side effect information about glipizide. Some of the dosage forms listed on this page may not apply to the brand name Glucotrol.

Some side effects of Glucotrol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to glipizide: oral tablet, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking glipizide (the active ingredient contained in Glucotrol) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking glipizide and call your doctor at once if you have a serious side effect such as:

• easy bruising or bleeding (nosebleeds, bleeding gums), feeling tired or short of breath, rapid heart rate;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• pale skin, fever, confusion; or

• throbbing headache, severe nausea and vomiting, fast or pounding heartbeats, sweating or thirst, feeling like you might pass out.

Less serious side effects of glipizide may include:

• mild nausea;

• diarrhea, constipation;

• dizziness, drowsiness; or

• skin rash, redness, or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to glipizide: compounding powder, oral tablet, oral tablet extended release

General

Glipizide (the active ingredient contained in Glucotrol) has been usually well tolerated. Side effects were reported in 3% to 12% of patients in clinical trials. These effects were serious enough to result in discontinuation of therapy in only 0.3% to 3% of patients.

Metabolic

Hypoglycemia, an extension of glipizide (the active ingredient contained in Glucotrol) s pharmacologic effects, may be severe, protracted, refractory to glucose infusion, and, in some cases, may require diazoxide. Hypoglycemia may present as coma or disturbed consciousness. Other signs of hypoglycemia include tachycardia, tremors, and increased sweating. In one review of 19 spontaneously reported cases, the mean dose of glipizide associated with hypoglycemia was 10 mg per day. The mean age in these cases was 75 years. Two patients died, although their cases were complicated and the degree to which hypoglycemia contributed to their deaths cannot be ascertained.

Patients with renal dysfunction, liver disease, or adrenal or pituitary insufficiency may be at increased risk for hypoglycemia as are those who are elderly, debilitated, or malnourished. In addition, acute illness, lack of adherence to diet, ethanol ingestion, or strenuous exercise may precipitate hypoglycemia.

Metabolic side effects have included hypoglycemia, an extension of glipizide's pharmacologic effects. Hypoglycemia has been be severe and protracted in some cases. Fatalities have been reported. Hyponatremia, disulfiram-like reactions, and coproporphyria have also been reported. Elderly patients may be at increased risk for hypoglycemia based on case reviews demonstrating an increased proportion of severe hypoglycemic events in patients aged 60 years and older.

Hematologic

Hematologic side effects have included rare reports of leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia.

Hepatic

Hepatic side effects have included rare reports of mild elevations in alkaline phosphatase, SGOT, and SGPT. The manufacturer has noted one case of jaundice. Cholestatic jaundice and hepatitis have been reported with other sulfonylureas. Frequent monitoring of liver function tests is recommended during the initiation of glipizide (the active ingredient contained in Glucotrol) therapy in patients with liver dysfunction.

Dermatologic

Dermatologic side effects have included rash in 0.5% to 1.4% of patients. Allergic skin reactions have occurred as well and included erythema, morbilliform or maculopapular eruptions, urticaria, pruritus, and eczema. Photosensitivity has been reported with other sulfonylureas.

Gastrointestinal

Gastrointestinal side effects have occurred in up to 3.7% of patients in clinical trials and included nausea, heartburn, vomiting, diarrhea, constipation, and abdominal pain. Gastrointestinal side effects have tended to be mild and transient. In postmarketing experience of the extended release product, the additional side effects of abdominal pain has been reported.

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