Glynase PresTab Side Effects

Generic Name: glyburide

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

Not all side effects for Glynase PresTab may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to glyburide: oral tablet

In addition to its needed effects, some unwanted effects may be caused by glyburide (the active ingredient contained in Glynase PresTab). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking glyburide:

Less common
  • Difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives
  • itching
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing
Rare
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • diarrhea
  • fever
  • headache
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • rash
  • unpleasant breath odor
  • upper right abdominal 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
  • difficulty with breathing
  • fast or irregular heartbeat
  • fluid-filled skin blisters
  • general body swelling
  • high fever
  • hostility
  • increased thirst
  • irritability
  • itching of the skin
  • 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
  • seizures
  • 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

If any of the following symptoms of overdose occur while taking glyburide, get emergency help immediately:

Symptoms of overdose
  • Anxiety
  • cold sweats
  • cool, pale skin
  • increased hunger
  • nervousness
  • nightmares
  • shakiness
  • slurred speech

Some of the side effects that can occur with glyburide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Indigestion
  • passing of gas
Incidence not known
  • Difficulty with moving
  • itching
  • joint pain
  • redness or other discoloration of the skin
  • severe sunburn
  • swollen joints

For Healthcare Professionals

Applies to glyburide: compounding powder, oral tablet

Metabolic

Hypoglycemia, an extension of glyburide (the active ingredient contained in Glynase PresTab) 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 (the active ingredient contained in Glynase PresTab) 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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