Glipizide Side Effects

Brand Names: Glucotrol XL, Glucotrol

Please note - some side effects for Glipizide 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 Glipizide - for the Consumer

Glipizide/Metformin

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 Glipizide/Metformin:

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; dizziness or lightheadedness; fainting; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of 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 drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.

Glipizide

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 Glipizide:

Diarrhea; dizziness; drowsiness; headache; nausea.

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

Glipizide Extended-Release Tablets

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 Glipizide Extended-Release Tablets:

Diarrhea; dizziness; gas; nausea.

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

Glipizide Side Effects - for the Professional

Glipizide

In U.S. and foreign controlled studies, the frequency of serious adverse reactions reported was very low. Of 702 patients, 11.8% reported adverse reactions and in only 1.5% was Glipizide discontinued.

Hypoglycemia

See PRECAUTIONS and OVERDOSAGE sections.

Gastrointestinal

Gastrointestinal disturbances are the most common reactions. Gastrointestinal complaints were reported with the following approximate incidence: nausea and diarrhea, one in seventy; constipation and gastralgia, one in one hundred. They appear to be dose-related and may disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with sulfonylureas: Glipizide should be discontinued if this occurs.

Dermatologic

Allergic skin reactions including erythema, morbilliform or maculopapular eruptions, urticaria, pruritus, and eczema have been reported in about one in seventy patients. These may be transient and may disappear despite continued use of Glipizide; if skin reactions persist, the drug should be discontinued. Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.

Hematologic

Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic

Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas. In the mouse, Glipizide pretreatment did not cause an accumulation of acetaldehyde after ethanol administration. Clinical experience to date has shown that Glipizide has an extremely low incidence of disulfiram-like alcohol reactions.

Endocrine Reactions

Cases of hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulfonylureas.

Miscellaneous

Dizziness, drowsiness, and headache have each been reported in about one in fifty patients treated with Glipizide. They are usually transient and seldom require discontinuance of therapy.

Laboratory Tests

The pattern of laboratory test abnormalities observed with Glipizide was similar to that for other sulfonylureas. Occasional mild to moderate elevations of SGOT, LDH, alkaline phosphatase, BUN and creatinine were noted. One case of jaundice was reported. The relationship of these abnormalities to Glipizide is uncertain, and they have rarely been associated with clinical symptoms.

Side Effects by Body System

General

Glipizide 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'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 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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