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

Applies to glyburide: oral tablet.

Serious side effects of Glynase PresTab

Along with its needed effects, glyburide (the active ingredient contained in Glynase PresTab) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking glyburide:

Rare

• Abdominal or stomach pain
• chills
• clay-colored stools
• dark urine
• diarrhea
• dizziness
• fever
• headache
• itching or rash
• loss of appetite
• nausea
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Anxiety
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• chest pain
• cold sweats
• coma
• confusion
• cool, pale skin
• cough
• depression
• fast heartbeat
• increased hunger
• nervousness
• nightmares
• painful or difficult urination
• pinpoint red spots on the skin
• seizures
• shakiness
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur while taking glyburide:

Symptoms of overdose

• Anxiety
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• dizziness
• fast heartbeat
• headache
• increased hunger
• nausea
• nervousness
• nightmares
• seizures
• shakiness
• slurred speech
• unusual tiredness or weakness

Other side effects of Glynase PresTab

Some side effects of glyburide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Heartburn
• hives or welts
• redness of the skin

Incidence not known

• Increased sensitivity of the skin to sunlight
• redness or other discoloration of the skin
• severe sunburn

For Healthcare Professionals

Applies to glyburide: compounding powder, oral tablet.

General

Like all sulfonylureas, this drug may commonly cause hypoglycemia and in some case it may be severe. Proper patient selection, dose, and patient instructions are important to avoid hypoglycemic episodes.^[Ref]

Metabolic

Glyburide (the active ingredient contained in Glynase PresTab)

Very rare (less than 0.01%): Disulfiram-like reaction

Frequency not reported: Hypoglycemia, hyponatremia, weight gain, lactic acidosis, syndrome of inappropriate antidiuretic hormone (SIADH) secretion

Sulfonylureas:

Frequency not reported: Hepatic porphyria

Neonatal Diabetes:

Very common (10% or more): Hypoglycemia^[Ref]

Gastrointestinal

Adverse gastrointestinal effects occur in about 1% to 2% of patients and appear to be dose related; they may subside following a dose reduction. Pancreatitis has been reported rarely.^[Ref]

Common (1% to 10%): Nausea, vomiting, epigastric fullness or sensation of pressure, abdominal pain, anorexia, dyspepsia, diarrhea, heartburn

Rare (less than 0.1%): Pancreatitis

Neonatal Diabetes:

Very common (10% or more): Transitory diarrhea, abdominal pain, vomiting, dyspepsia

Common (1% to 10%): Tooth discoloration^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Allergic vasculitis

Frequency not reported: Allergic skin reactions including pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, angioedema, arthralgia, myalgia, vasculitis, erythema multiforme, erythema nodosum, bullous eruptions, exfoliative dermatitis, photosensitivity, Stevens-Johnson syndrome^[Ref]

Allergic skin reactions including pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions occurred in 1.5 % of patients during clinical trials. In some cases these were transient and disappeared despite continue therapy. Hypersensitivity reactions affecting the skin usually occur within the first 6 weeks of treatment with a sulfonylurea.^[Ref]

Dermatologic

Glyburide (the active ingredient contained in Glynase PresTab)

Common (1% to 10%): Allergic skin reactions including pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions

Frequency not reported: Alopecia/hypotrichoses, increased sweating, facial edema, angioedema, bullous reactions, erythema multiforme, exfoliative dermatitis

Sulfonylureas:

-Frequency not reported: Porphyria cutanea tarda, photosensitivity reactions^[Ref]

Allergic skin reactions including pruritus, erythema, urticaria, morbilliform, erythematous and maculopapular and bullous skin eruptions or psoriasiform drug eruptions occurred in 1.5 % of patients during clinical trials. These may be transient and may disappear despite continued therapy. Bullous reactions, erythema multiforme, and exfoliative dermatitis have been reported. If skin reactions persist, this drug should be discontinued.^[Ref]

Ocular

Changes in accommodation and/or blurred vision are thought to be related to fluctuations in glucose levels.^[Ref]

Frequency not reported: Changes in accommodation and/or blurred vision, diplopia, visual disturbances, blindness^[Ref]

Hematologic

Glyburide (the active ingredient contained in Glynase PresTab)

Postmarketing reports: Hemolytic anemia

Sulfonylureas:

Frequency not reported: Leukopenia, agranulocytosis, thrombocytopenia, thrombocytopenia purpura, eosinophilia, bone marrow aplasia, coagulation disorders, hemolytic anemia, aplastic anemia, anemia, pancytopenia^[Ref]

Hepatic

Glyburide (the active ingredient contained in Glynase PresTab)

Rare (less than 0.1%): Cholestatic jaundice, hepatitis

Frequency not reported: Liver function abnormalities including isolated transaminase elevations

Postmarketing reports:

Sulfonylureas:

Frequency not reported: Increased liver enzymes (AST, ALT), abnormal liver function, cholestasis, cholestatic hepatitis, granulomatous hepatitis, bilirubinemia

Neonatal Diabetes:

Very common (10% or more): Transient increased transaminases^[Ref]

Renal

Frequency not reported: Abnormal renal function, acute renal failure^[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, arthritis^[Ref]

Nervous system

Frequency not reported: Paresthesia, tremor, convulsions, encephalopathy, confusion, headache, cerebrovascular disorders^[Ref]

Other

Frequency not reported: Deafness, fever^[Ref]

Psychiatric

Frequency not reported: Acute psychosis^[Ref]