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Glynase PresTab Side Effects

Generic Name: glyburide

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

For the Consumer

Applies to glyburide: oral tablet

Side effects requiring immediate medical attention

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:

Less common

  • Difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, skin rash
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness

Rare

  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • diarrhea
  • fever
  • headache
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • unpleasant breath odor
  • upper right abdominal or stomach pain
  • vomiting of blood
  • yellow eyes and skin

Incidence not known

  • Agitation
  • back, leg, or stomach pains
  • bleeding gums
  • blood in the urine or stools
  • bloody, black, or tarry stools
  • blurred vision
  • change in near or distance vision
  • chest pain
  • coma
  • confusion
  • convulsions
  • cough or hoarseness
  • decreased urine output
  • depression
  • difficulty in focusing eyes
  • fast or irregular heartbeat
  • fluid-filled skin blisters
  • general body swelling
  • high fever
  • hostility
  • increased thirst
  • irritability
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • lower back or side pain
  • muscle pain or cramps
  • muscle twitching
  • nosebleeds
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rapid weight gain
  • sensitivity to the sun
  • skin thinness
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stupor
  • swelling of the face, ankles, or hands
  • swollen or painful 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
  • cold sweats
  • cool, pale skin
  • increased hunger
  • nervousness
  • nightmares
  • shakiness
  • slurred speech

Side effects not requiring immediate medical attention

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

Incidence not known

  • Difficulty with moving
  • joint pain
  • redness or other discoloration of the skin
  • severe sunburn
  • swollen joints

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]

References

1. "Product Information. Glynase PresTab (glyBURIDE)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Micronase (glyburide)." Pharmacia and Upjohn, Kalamazoo, MI.

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

5. "Product Information. Diabeta (glyburide)." Hoechst Marion-Roussel Inc, Kansas City, MO.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.