Glyburide Side Effects

Not all side effects for glyburide 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. 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'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.[Ref]

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.[Ref]

Hematologic

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

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.[Ref]

Renal

Renal side effects have included polyuria and nocturia.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Ocular

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

References

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

2. Kolterman OG "Glyburide in non-insulin-dependent diabetes: an update." Clin Ther 14 (1992): 196-213

3. "Glibenclamide: a review." Drugs 1 (1971): 116-40

4. Asplund K, Wiholm BE, Lithner F "Glibenclamide-associated hypoglycaemia: a report on 57 cases." Diabetologia 24 (1983): 412-7

5. Prendergast BD "Glyburide and glipizide, second-generation oral sulfonylurea hypoglycemic agents." Clin Pharm 3 (1984): 473-85

6. Sonnenblick M, Shilo S "Glibenclamide induced prolonged hypoglycaemia." Age Ageing 15 (1986): 185-9

7. Feldman JM "Glyburide: a second-generation sulfonylurea hypoglycemic agent. History, chemistry, metabolism, pharmacokinetics, clinical use and adverse effects." Pharmacotherapy 5 (1985): 43-62

8. Klonoff DC, Barrett BJ, Nolte MS, Cohen RM, Wyderski R "Hypoglycemia following inadvertent and factitious sulfonylurea overdosages." Diabetes Care 18 (1995): 563-7

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

10. Israeli A, Matzner Y, Or R, Raz I "Glibenclamide causing thrombocytopenia and bleeding tendency: case reports and a review of the literature." Klin Wochenschr 66 (1988): 223-4

11. Nataas OB, Nesthus I "Immune haemolytic anaemia induced by glibenclamide in selective IgA deficiency." Br Med J (Clin Res Ed) 295 (1987): 366-7

12. Goodman RC, Dean PJ, Radparvar A, Kitabchi AE "Glyburide-induced hepatitis." Ann Intern Med 106 (1987): 837-9

13. Del-Val A, Garrigues V, Ponce J, Benages R "Glibenclamide-induced cholestasis ." J Hepatol 13 (1991): 375

14. Wongpaitoon V, Mills PR, Russell RI, Patrick RS "Intrahepatic cholestasis and cutaneous bullae associated with glibenclamide therapy." Postgrad Med J 57 (1981): 244-6

15. Clarke BF, Campbell IW, Ewing DJ, Beveridge GW, MacDonald MK "Generalized hypersensitivity reaction and visceral arteritis with fatal outcome during glibenclamide therapy." Diabetes 23 (1974): 739-42

16. Saw D, Pitman E, Maung M, Savasatit P, Wasserman D, Yeung CK "Granulomatous hepatitis associated with glyburide." Dig Dis Sci 41 (1996): 322-5

17. Meadow P, Tullio CJ "Glyburide-induced hepatitis ." Clin Pharm 8 (1989): 470

18. Rado JP, Borbely L "Enchancement of polyuria by glibenclamide in diabetes insipidus." Lancet 2 (1971): 216

19. Shaw KM, Bloom A, Bulpitt CJ "Glibenclamide and nocturia ." Br Med J 1 (1977): 1415

20. Landor M, Rosenstreich DL "Vesiculobullous rash in a patient with systemic lupus erythematosus." Ann Allergy 70 (1993): 196-203

21. Paterson AJ, Lamey PJ, Lewis MA, Nolan A, Rademaker M "Pemphigus vulgaris precipitated by glibenclamide therapy." J Oral Pathol Med 22 (1993): 92-5

22. Teller J, Rasin M, Abraham FA "Accommodation insufficiency induced by glybenclamide." Ann Ophthalmol 21 (1989): 275-6

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