glyburide
Pharmaranks rates Glyburide 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Glyburide is a sulfonylurea used to treat Type 2 Diabetes Mellitus.
Sulfonylurea · by Epic Pharma LLC
Generic of Diabeta
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Glyburide
- Drug class
- Sulfonylurea
- Form
- Tablet
- Strength
- Glyburide 1.25MG · Glyburide 2.5MG · Glyburide 5MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- type 2 diabetes mellitus
- Manufacturer
- Epic Pharma LLC
- Half-life
- about 10 hours (terminal/elimination half-life) (how long it stays in your system)
- What the pharmacy pays
- ~$1.97 for 30 — not your price
- FDA application
- ANDA076257
What is Glyburide?
From the FDA label:Glyburide tablets, USP contain a smaller particle size glyburide, which is an oral blood-glucose-lowering drug of the sulfonylurea class. Glyburide is a white, crystalline compound, formulated as glyburide tablets, USP of 1.25, 2.5, and 5 mg strengths for oral administration. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate. In addition, the 2.5 mg contains FD&C Red No.40 and the 5 mg contains FD&C Blue No.1. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)-ethyl]phenyl]-sulfonyl]-3-cyclohexylurea and the molecular weight is 493.99. The structural formula is represented below.
How to use
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. Transfer…
Side effects
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…
Who should not take Glyburide
Glyburide tablets are contraindicated in patients with: Known hypersensitivity or allergy to the drug. Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. Type I diabetes mellitus. Concomitant administration of bosentan. SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups. UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of glyburide tablets and of alternative modes of therapy. Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Glyburide stay in your body?
The elimination half-life of glyburide is about 10 hours (terminal/elimination half-life) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label says the fall in glyburide serum levels in healthy people is biphasic — this 10 hours is the terminal (elimination) phase, not the earlier distribution phase. Glyburide is not a prodrug. It has two metabolites (the 4-trans-hydroxy and 3-cis-hydroxy derivatives), but the label states they are only weakly active (about 1/400th and 1/40th as active as glyburide in rabbits) and "probably contribute no significant hypoglycemic action in humans," so there is no active metabolite that outlasts the parent in a clinically meaningful way. The label gives no separate half-life numbers for older adults, kidney impairment, or liver impairment — it does warn that impaired kidney or liver function can raise glyburide levels and that liver impairment reduces gluconeogenesis, both raising hypoglycemia risk, and that older adults are prone to kidney insufficiency and are particularly susceptible to hypoglycemia. Glyburide is unusual among sulfonylureas in being cleared by two routes, roughly 50% in bile and 50% in urine, as metabolites. This is a pharmacokinetic figure, not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Glyburide tablets, USP — FDA label (DailyMed), CLINICAL PHARMACOLOGY / Pharmacokinetics.
Drug class
May treat (source: NIH RxClass)
See how Glyburide ranks — best-rated sulfonylurea for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Glyburide treat?
- Glyburide (Glyburide) may be used to treat type 2 diabetes mellitus, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Glyburide rated?
- pharmaranks gives Glyburide a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Glyburide cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.97 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Glimepiride — about $1.00 on the same basis.
- Is there a coupon or discount for Glyburide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Glyburide. To pay less, Glyburide is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Glyburide?
- Glyburide is marketed by Epic Pharma LLC. You can see Epic Pharma LLC's full profile, rating, and other products on pharmaranks.
- Is Glyburide a brand-name or generic drug?
- Glyburide is a generic medication; its active ingredient is Glyburide. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Glyburide available over the counter?
- No. Glyburide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Glyburide come in?
- Glyburide is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Glyburide?
- Glyburide is classified as sulfonylurea, per the FDA's Established Pharmacologic Class.
- Is Glyburide FDA-registered?
- Glyburide is on record with the U.S. FDA under application number ANDA076257. You can verify this on its official FDA label.
- Has Glyburide been recalled by the FDA?
- Glyburide has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Glyburide safe?
- There's no single safe-or-not verdict. pharmaranks gives Glyburide a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Glyburide?
- Glyburide's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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glyburide
70/100