pharmacopeia
GET
/api/v1/drug/glyburide
2D structure
5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl)phenyl]ethyl]-2-methoxybenzamide
SMILES COC1=C(C=C(C=C1)Cl)C(=O)NCCC2=CC=C(C=C2)S(=O)(=O)NC(=O)NC3CCCCC3
InChIKey ZNNLBTZKUZBEKO-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Insulin Receptor Agonists; Potassium Channel Interactions.

Insulin Receptor

Indications

Sourced from openFDA
  • Glyburide tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.ICD-10: E11.9

Contraindications

Sourced from openFDA
  • Glyburide tablets are contraindicated in patients with: Known hypersensitivity or allergy to the drug. Diabetic ketoacidosis, with or without coma.contraindicated

Dosage & administration

Sourced from openFDA

Patients should be retitrated when transferred from glyburide tablets or other oral hypoglycemic agents. There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets. In addition to the usual monitoring of urinary glucose, the patient's blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, ie , inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, ie , loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient's response to therapy. Short-term administration of glyburide tablets may be sufficient during periods of transient loss of control in patients usually controlled well on diet. Usual Starting Dose The usual starting dose of glyburide tablets is 2.5 to 5 mg daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1.25 mg daily. (See PRECAUTIONS section for patients at increased risk.) Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.

Adverse reactions

Sourced from openFDA

Hypoglycemia: See Precautions and Overdosage Sections. Gastrointestinal Reactions: Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; glyburide tablets should be discontinued if this occurs. Liver function abnormalities, including isolated transaminase elevations, have been reported. Gastrointestinal disturbances, eg , nausea, epigastric fullness, and heartburn are the most common reactions, having occurred in 1.8% of treated patients during clinical trials. They tend to be dose related and may disappear when dosage is reduced. Dermatologic Reactions: Allergic skin reactions, eg , pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions occurred in 1.5% of treated patients during clinical trials. These may be transient and may disappear despite continued use of glyburide tablets; if skin reactions persist, the drug should be discontinued. Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas. Hematologic Reactions: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia (see PRECAUTIONS ), aplastic anemia, and pancytopenia have been reported with sulfonylureas. Metabolic Reactions: Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas; however, hepatic porphyria has not been reported with Glyburide tablets and disulfiram-like reactions have been reported very rarely.

Overdosage

Sourced from openFDA

Overdosage of sulfonylureas, including glyburide tablets, can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological findings, should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate which will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours, since hypoglycemia may recur after apparent clinical recovery.

Approval history

Sourced from openFDA
  • May 1, 1984NDANDA017532Sanofi Aventis Us
  • Aug 29, 1995ANDAANDA074388Teva
  • Apr 20, 1999ANDAANDA074686Teva
  • Nov 14, 2007ANDAANDA077870Aurobindo Pharma
  • Jun 3, 2009ANDAANDA079009Heritage
  • Feb 28, 2011ANDAANDA090937Heritage
  • Feb 29, 2016ANDAANDA206748Zydus Pharms
  • May 10, 2016ANDAANDA206749Zydus Pharms

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
24,183 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Blood Glucose Increased3,05913%
  2. 2Nausea2,0358.4%
  3. 3Weight Decreased1,5456.4%
  4. 4Drug Ineffective1,4175.9%
  5. 5Diarrhoea1,3045.4%
  6. 6Dizziness1,2105.0%
  7. 7Hypoglycaemia1,2035.0%
  8. 8Blood Glucose Decreased1,1684.8%
  9. 9Fatigue1,1504.8%
  10. 10Dyspnoea1,1094.6%
  11. 11Asthenia1,0594.4%
  12. 12Vomiting1,0354.3%
  13. 13Pain9553.9%
  14. 14Myocardial Infarction9053.7%
  15. 15Decreased Appetite8903.7%

Literature

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Recent PubMed references pinned to Glyburide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 139 ClinicalTrials.gov registrations naming Glyburide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Glyburide. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • G6PDCPIC CClinPGx 3FDA label: Actionable PGx
    G6PD

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Glyburide work?
Mechanism-of-action classes: Insulin Receptor Agonists; Potassium Channel Interactions.
What is Glyburide used for?
According to FDA labeling, Glyburide carries indications including: Glyburide tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Glyburide?
Glyburide is classified as Sulfonylureas, Sulfonylurea, Insulin Receptor Agonists, Potassium Channel Interactions, Decreased Glycolysis, Increased Diuresis, Increased Glucose Transport into Cells, Increased Insulin Secretion.
What are the brand names for Glyburide?
Glyburide is marketed under brand names including Glynase.
What are the contraindications for Glyburide?
Glyburide labeling lists contraindications including: Glyburide tablets are contraindicated in patients with: Known hypersensitivity or allergy to the drug. Diabetic ketoacidosis, with or without coma.. Always consult the full prescribing information and a clinician.
Note. Data for glyburide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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