Glyburide Side Effects

Some side effects of glyburide 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 glyburide: oral tablet

Stop using glyburide and Get emergency medical help if you have any of these signs of an allergic reaction while taking glyburide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medication and call your doctor at once if you have any of these serious side effects:

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

• pale skin, confusion or weakness;

• easy bruising or bleeding, purple or red pinpoint spots under your skin; or

• headache, trouble concentrating, memory problems, feeling unsteady, hallucinations, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects of glyburide may include:

• mild nausea, heartburn, feeling full;

• joint or muscle pain;

• blurred vision; or

• mild itching or skin rash.

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 glyburide: compounding powder, oral tablet

Metabolic

Hypoglycemia, an extension of glyburide's pharmacologic effects, may be severe, protracted, refractory to glucose infusion, and, in some cases, may require diazoxide. It most commonly presents as coma or disturbed consciousness. Other signs of hypoglycemia include tachycardia, tremor, chest pain, weakness, and increased sweating. In one review of 57 spontaneously reported cases, the mean dose of glyburide associated with hypoglycemia was 10 mg per day although there were cases with doses as low as 2.5 mg per day. The median age in these cases was 75 years. Ten patients died. In another review of 13 cases, in which renal failure, advanced age, and congestive heart failure were deemed to be predisposing factors, hypoglycemia persisted for more than 60 hours in two patients.

Patients with renal dysfunction, liver disease, adrenal or pituitary insufficiency, or congestive heart failure 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 glyburide's pharmacologic effects, in 1.6% to 3.1% of patients. Hypoglycemia has been severe and protracted in some cases. Fatalities have been reported. In addition, hyponatremia and disulfiram-like reactions have been reported. Glyburide metabolism and elimination, as well as hepatic gluconeogenesis and glycogenolysis, may be impaired in patients with renal dysfunction and/or liver disease.

Hematologic

Hematologic side effects have included rare reports of leukopenia, thrombocytopenia, eosinophilia, and hemolytic anemia.

Hepatic

Hepatic side effects have included cholestatic jaundice and hepatitis which may rarely progress to liver failure. Elevations in serum transaminase, alkaline phosphatase, and bilirubin have been reported. Elevations in liver function tests were usually mild and often returned to normal despite continued therapy. Rare cases of acute hepatic hypersensitivity characterized by pruritus, icterus, and cholestatic jaundice have also been reported. In addition, at least two cases of granulomatous hepatitis have been associated with glyburide use.

Renal

Renal side effects have included polyuria and nocturia.

Dermatologic

Dermatologic side effects have occurred in 1.5% of patients in clinical trials and include pruritus, erythema, urticaria, morbilliform and maculopapular eruptions, and vesiculobullous rash. In addition, pemphigus vulgaris, porphyria cutanea tarda, Stevens-Johnson syndrome, and photosensitivity were reported.

Gastrointestinal

Gastrointestinal side effects have occurred in up to 1.8% of patients in clinical trials and included nausea, vomiting, dyspepsia, abdominal fullness, diarrhea, and anorexia. Gastrointestinal side effects tended to be mild and transient.

Hypersensitivity

Hypersensitivity side effects have predominantly included dermatological effects but have also included acute hepatic hypersensitivity, cholestatic jaundice, necrotizing angiitis, hemolytic anemia, angioedema, arthralgia, myalgia, and vasculitis.

Ocular

Ocular side effects have included changes in accommodation and blurred vision.

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