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Medicine guide

Glipizide

10 mg · Tablet, Extended Release

  • Prescription only
  • Sulfonylurea
Active substance
Glipizide
Made by
St. Mary's Medical Park Pharmacy

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-06-03

What it is

Sulfonylurea

Used for
  • Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in
The label’s usual adult dose

Recommended starting dose is 5 mg once daily.

Maximum recommended dose is 20 mg once daily ( 2.1 ).

Full directions ↓
Do not take it if

Glipizide is contraindicated in patients with:

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
84other products contain Glipizide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

adults with type 2 diabetes mellitus Limitations of Use:

  • Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in
  • adults with type 2 diabetes mellitus.
  • Glipizide extended-release tablets is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in
  • Not for treatment of type 1 diabetes or diabetic ketoacidosis
  • 1.1 Limitations of Use Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

From the official label · 2026-06-03 · DailyMed

How it works

From this product’s own US prescribing label.

Glipizide primarily lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets.

Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, leading to closure of the ATP-sensitive potassium channel, thereby stimulating the release of insulin.

Peak level after6–12 h
Half-life2–5 h
Mostly cleared after≈ 17.5 hfive half-lives — our arithmetic
How it leaves the body

Glipizide is eliminated primarily by hepatic biotransformation: less than 10% of a dose is excreted as unchanged drug in urine and feces; approximately 90% of a dose is excreted as biotransformation products in urine (80%) and feces (10%).

With food

Administration of glipizide extended-release tablets with food has no effect on the 2 to 3 hour lag time in drug absorption.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-06-03

Do not take it if

  • Glipizide is contraindicated in patients with:
  • Known hypersensitivity to glipizide or any of the product’s ingredients.
  • Hypersensitivity to sulfonamide derivatives. Known hypersensitivity to glipizide or any of the product’s ingredients ( 4 ). Hypersensitivity to sulfonamide derivatives ( 4 ).

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Recommended starting dose is 5 mg once daily.
  • Dose adjustment can be made based on the patient’s glycemic control.
  • Maximum recommended dose is 20 mg once daily ( 2.1 ).
  • Administer with breakfast or the first meal of the day ( 2.1 ).
  • For combination therapy with other blood-glucose-lowering agents, initiate the agent at the lowest recommended dose, and observe patients for hypoglycemia ( 2.2 ).
  • 2.1 Recommended Dosing Glipizide extended-release tablets should be administered orally with breakfast or the first main meal of the day.
  • The recommended starting dose of glipizide extended-release tablets is 5 mg once daily.
  • Start patients at increased risk for hypoglycemia (e.g., the elderly or patients with hepatic insufficiency) at 2.5 mg [see Use in Specific Population (8.5, 8.6) ] .
  • Dosage adjustment can be made based on the patient’s glycemic control.
  • The maximum recommended dose is 20 mg once daily.
  • Patients receiving immediate release glipizide may be switched to glipizide extended-release tablets once daily at the nearest equivalent total daily dose.
  • 2.2 Use with Other Glucose Lowering Agents When adding glipizide extended-release tablets to other anti-diabetic drugs, initiate glipizide extended-release tablets at 5 mg once daily.
  • Start patients at increased risk for hypoglycemia at a lower dose.
  • When colesevelam is coadministered with glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced.
  • Therefore, glipizide extended-release tablets should be administered at least 4 hours prior to colesevelam.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Hypoglycemia:
  • May be severe. Ensure proper patient selection, dosing, and instructions, particularly in at-risk populations (e.g., elderly, renally impaired) and when used with other anti-diabetic medications ( 5.1 ).
  • Hemolytic Anemia:
  • Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-sulfonylurea alternative ( 5.2 ).
  • Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas:
  • Inform patient of risks, benefits and treatment alternatives ( 5.3 ).
  • Macrovascular Outcomes:
  • No clinical studies have established conclusive evidence of macrovascular risk reduction with glipizide extended-release tablets or any other anti-diabetic drug ( 5.4 ). 5.1 Hypoglycemia All sulfonylurea drugs, including glipizide extended-release tablets, are capable of producing severe hypoglycemia [see Adverse Reactions (6) ] . Concomitant use of glipizide extended-release tablets with other anti-diabetic medication can increase the risk of hypoglycemia. A lower dose of glipizide extended-release tablets may be required to minimize the risk of hypoglycemia when combining it with other anti-diabetic medications. Educate patients to recognize and manage hypoglycemia. When initiating and increasing glipizide extended-release tablets in patients who may be predisposed to hypoglycemia (e.g., the elderly, patients with renal impairment, patients on other anti-diabetic medications) start at 2.5 mg. Debilitated or malnourished patients, and those with adrenal, pituitary, or hepatic impairment are particularly susceptible to the hypoglycemic action of anti-diabetic medications. Hypoglycemia is also more likely to occur when caloric intake is deficient, after severe or prolonged exercise, or when alcohol is ingested. The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. Early warning symptoms of hypoglycemia may be different or less pronounced in patients with autonomic neuropathy, the elderly, and in patients who are taking beta-adrenergic blocking medications or other sympatholytic agents. These situations may result in severe hypoglycemia before the patient is aware of the hypoglycemia . These impairments may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Severe hypoglycemia can lead to unconsciousness or convulsions and may result in temporary or permanent impairment of brain function or death. 5.2 Hemolytic Anemia Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents, including glipizide extended-release tablets, can lead to hemolytic anemia.
  • Avoid use of glipizide extended-release tablets in patients with G6PD deficiency. In post marketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency. 5.3 Increased Risk of Cardiovascular Mortality with Sulfonylureas 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 type 2 diabetes mellitus. 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 glipizide 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. 5.4 Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with glipizide extended-release tablets or any other anti-diabetic drug. 5.5 Gastrointestinal Obstruction There have been reports of obstructivesymptomsinpatientswithknownstricturesinassociationwiththe ingestion of anotherdrugwiththisextendedreleaseformulation.Avoiduse of glipizide extended-release tablets inpatientswithpreexistingseveregastrointestinalnarrowing(pathologic or iatrogenic).

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Available data from a small number of published studies and postmarketing experience with glipizide extended-release tablets use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes.
  • However, sulfonylureas (including glipizide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia.
  • Therefore, glipizide extended-release tablets should be discontinued at least two weeks before expected delivery (see Clinical Considerations).
  • Poorly controlled diabetes in pregnancy is also associated with risks to the mother and fetus (see Clinical Considerations).
  • In animal studies, there were no effects on embryofetal development following administration of glipizide to pregnant rats and rabbits during organogenesis at doses 833 times and 8 times the human dose based on body surface area, respectively.
  • However, increased pup mortality was observed in rats administered glipizide from gestation day 15 throughout lactation at doses 2 times the maximum human dose based on body surface area (see Data).
  • The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20 to 25% in women with HbA1c >10.
  • The estimated background risk of miscarriage for the indicated population is unknown.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
  • Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, miscarriage, preterm delivery, stillbirth, and delivery complications.
  • Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.
  • Fetal/Neonatal Adverse Reactions Neonates of women with gestational diabetes who are treated with sulfonylureas during pregnancy may be at increased risk for neonatal intensive care admission and may develop respiratory distress, hypoglycemia, birth injury, and be large for gestational age.
  • Prolonged severe hypoglycemia, lasting 4 to 10 days, has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery and has been reported with the use of agents with a prolonged half-life.
  • Observe newborns for symptoms of hypoglycemia and respiratory distress and manage accordingly.
  • Dose adjustments during pregnancy and the postpartum period Due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving a sulfonylurea at the time of delivery, glipizide extended-release tablets should be discontinued at least two weeks before expected delivery (see Fetal/Neonatal Adverse Reactions).
  • Data Animal Data In teratology studies in rats and rabbits, pregnant animals received daily oral doses of glipizide during the period of organogenesis at doses up to 2000 mg/kg/day and 10 mg/kg/day (approximately 833 and 8 times the human dose based on body surface area), respectively.
  • There were no adverse effects on embryo-fetal development at any of the doses tested.
  • In a peri- and postnatal study in pregnant rats, there was a reduced number of pups born alive following administration of glipizide from gestation day 15 throughout lactation through weaning at doses ≥5 mg/kg/day (about 2 times the recommended maximum human dose based on body surface area).
  • Risk Summary Breastfed infants of lactating women using glipizide extended-release tablets should be monitored for symptoms of hypoglycemia (see Clinical Considerations).
  • Although glipizide was undetectable in human milk in one small clinical lactation study; this result is not conclusive because of the limitations of the assay used in the study.
  • There are no data on the effects of glipizide on milk production.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glipizide extended-release tablets and any potential adverse effects on the breastfed child from glipizide extended-release tablets or from the underlying maternal condition.
  • Clinical Considerations Monitoring for adverse reactions Monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, apnea, hypothermia, excessive sleepiness, poor feeding, seizures).
  • IN SPECIFIC POPULATIONS
  • Geriatric, Hepatically Impaired Patients:
  • At risk for hypoglycemia with glipizide extended-release tablets. Use caution in dose selection and titration, and monitor closely ( 8.5 , 8.6 ). 8.1 Pregnancy Risk Summary Available data from a small number of published studies and postmarketing experience with glipizide extended-release tablets use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glipizide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, glipizide extended-release tablets should be discontinued at least two weeks before expected delivery (see Clinical Considerations). Poorly controlled diabetes in pregnancy is also associated with risks to the mother and fetus (see Clinical Considerations). In animal studies, there were no effects on embryofetal development following administration of glipizide to pregnant rats and rabbits during organogenesis at doses 833 times and 8 times the human dose based on body surface area, respectively. However, increased pup mortality was observed in rats administered glipizide from gestation day 15 throughout lactation at doses 2 times the maximum human dose based on body surface area (see Data). The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20 to 25% in women with HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, miscarriage, preterm delivery, stillbirth, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Fetal/Neonatal Adverse Reactions Neonates of women with gestational diabetes who are treated with sulfonylureas during pregnancy may be at increased risk for neonatal intensive care admission and may develop respiratory distress, hypoglycemia, birth injury, and be large for gestational age. Prolonged severe hypoglycemia, lasting 4 to 10 days, has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery and has been reported with the use of agents with a prolonged half-life. Observe newborns for symptoms of hypoglycemia and respiratory distress and manage accordingly. Dose adjustments during pregnancy and the postpartum period Due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving a sulfonylurea at the time of delivery, glipizide extended-release tablets should be discontinued at least two weeks before expected delivery (see Fetal/Neonatal Adverse Reactions). Data Animal Data In teratology studies in rats and rabbits, pregnant animals received daily oral doses of glipizide during the period of organogenesis at doses up to 2000 mg/kg/day and 10 mg/kg/day (approximately 833 and 8 times the human dose based on body surface area), respectively. There were no adverse effects on embryo-fetal development at any of the doses tested. In a peri- and postnatal study in pregnant rats, there was a reduced number of pups born alive following administration of glipizide from gestation day 15 throughout lactation through weaning at doses ≥5 mg/kg/day (about 2 times the recommended maximum human dose based on body surface area). 8.2 Lactation Risk Summary Breastfed infants of lactating women using glipizide extended-release tablets should be monitored for symptoms of hypoglycemia (see Clinical Considerations). Although glipizide was undetectable in human milk in one small clinical lactation study; this result is not conclusive because of the limitations of the assay used in the study. There are no data on the effects of glipizide on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for glipizide extended-release tablets and any potential adverse effects on the breastfed child from glipizide extended-release tablets or from the underlying maternal condition. Clinical Considerations Monitoring for adverse reactions Monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, apnea, hypothermia, excessive sleepiness, poor feeding, seizures). 8.4 Pediatric Use Safety and effectiveness in children have not been established. 8.5 Geriatric Use There were no overall differences in effectiveness or safety between younger and older patients, but greater sensitivity of some individuals cannot be ruled out. Elderly patients are particularly susceptible to the hypoglycemic action of anti-diabetic agents. Hypoglycemia may be difficult to recognize in these patients. Therefore, dosing should be conservative to
  • avoid hypoglycemia [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ]. 8.6 Hepatic Impairment There is no information regarding the effects of hepatic impairment on the disposition of glipizide. However, since glipizide is highly protein bound and hepatic biotransformation is the predominant route of elimination, the pharmacokinetics and/or pharmacodynamics of glipizide may be altered in patients with hepatic impairment. If hypoglycemia occurs in such patients, it may be prolonged and appropriate management should be instituted [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • Certain medications may affect glucose metabolism, requiring glipizide extended-release tablets dose adjustment and close monitoring of blood glucose ( 7.1 ).
  • Miconazole:
  • Monitor patients closely. Severe hypoglycemia can occur when glipizide and oral miconazole are used concomitantly ( 7.2 , 12.3 ).
  • Fluconazole:
  • Monitor patients closely. An increase in glipizide AUC was seen after fluconazole administration ( 7.3 , 12.3 ).
  • Colesevelam:
  • Glipizide extended-release tablets should be administered at least 4 hours prior to colesevelam ( 7.4 , 12.3 ). 7.1 Drugs Affecting Glucose Metabolism A number of medications affect glucose metabolism and may require glipizide extended-release tablets dose adjustment and close monitoring for hypoglycemia or worsening glycemic control. The following are examples of medication that may increase the glucose lowering effect of glipizide extended-release tablets, increase the susceptibility to and/or intensity of hypoglycemia:
  • antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), sulfonamide antibiotics, nonsteroidal anti-inflammatory agents, chloramphenicol, probenecid, coumarins, voriconazole, H2 receptor antagonists, and quinolones. When these medications are administered to a patient receiving glipizide extended-release tablets, monitor the patient closely for hypoglycemia. When these medications are discontinued from a patient receiving glipizide extended-release tablets, monitor the patient closely for worsening glycemic control. The following are examples of medication that may reduce the glucose-lowering effect of glipizide extended-release tablets, leading to worsening glycemic control:
  • atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), thyroid hormones, phenytoin, nicotinic acid, and calcium channel blocking drugs. When such drugs are administered to patients receiving glipizide extended-release tablets, monitor the patients closely for worsening glycemic control. When these medications are discontinued from patients receiving glipizide extended-release tablets, monitor the patient closely for hypoglycemia. Alcohol, beta-blockers, clonidine, and reserpine may lead to either potentiation or weakening of the glucose-lowering effect. Increased frequency of monitoring may be required when glipizide extended-release tablets is co-administered with these drugs. The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic drugs such as beta-blockers, clonidine, guanethidine, and reserpine. Increased frequency of monitoring may be required when glipizide extended-release tablets is co-administered with these drugs. 7.2 Miconazole Monitor patients closely for hypoglycemia when glipizide extended-release tablets are co-administered with miconazole. A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported [see Clinical Pharmacology (12.3) ] . 7.3 Fluconazole Monitor patients closely for hypoglycemia when glipizide extended-release tablets are co-administered with fluconazole. Concomitant treatment with fluconazole increases plasma concentrations of glipizide, which may lead to hypoglycemia [see Clinical Pharmacology (12.3) ] . 7.4 Colesevelam Glipizide extended-release tablets should be administered at least 4 hours prior to the administration of colesevelam. Colesevelam can reduce the maximum plasma concentration and total exposure of glipizide when the two are coadministered [see Clinical Pharmacology (12.3) ] .

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • Overdosage of sulfonylureas including glipizide extended-release tablets can produce severe hypoglycemia.
  • Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated with oral glucose.
  • Severe hypoglycemic reactions with coma, seizure, or other neurological impairment are medical emergencies requiring immediate treatment.
  • The patient should be treated with glucagon or intravenous glucose.
  • Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery.
  • Clearance of glipizide from plasma may be prolonged in persons with liver disease.
  • Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in children have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • There were no overall differences in effectiveness or safety between younger and older patients, but greater sensitivity of some individuals cannot be ruled out.
  • Elderly patients are particularly susceptible to the hypoglycemic action of anti-diabetic agents.
  • Hypoglycemia may be difficult to recognize in these patients.
  • Therefore, dosing should be conservative to
  • avoid hypoglycemia [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

Quoted from the official label, section “Geriatric Use”.

Side effects

  • The followingserious adverse reactions are discussedinmoredetail below and elsewhereinthe labeling:
  • Hypoglycemia [see Warnings and Precautions (5.1) ] Hemolyticanemia [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence > 3%) are dizziness, diarrhea, nervousness, tremor, hypoglycemia and flatulence ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 580 patients from 31 to 87 years of age received glipizide extended-release tablets in doses from 5 mg to 60 mg in both controlled and open trials. The dosages above 20 mg are not recommended dosages. In these trials, approximately 180 patients were treated with glipizide extended-release tablets for at least 6 months. Table 1 summarizes the incidence of adverse reactions, other than hypoglycemia, that were reported in pooled double-blind, placebo-controlled trials in ≥3% of glipizide extended-release tablets-treated patients and more commonly than in patients who received placebo. Table 1:
  • Incidence (%) of Adverse Reactions Reported in ≥3% of Patients Treated in Placebo-Controlled Clinical Trials and More Commonly in Patients Treated with glipizide extended-release tablets (Excluding Hypoglycemia) Glipizide extended-release tablets (%) (N=278) Placebo (%) (N=69) Adverse Effect Dizziness 6.8 5.8 Diarrhea 5.4 0.0 Nervousness 3.6 2.9 Tremor 3.6 0.0 Flatulence 3.2 1.4 Hypoglycemia Of the 580 patients that received glipizide extended-release tablets in clinical trials, 3.4% had hypoglycemia documented by a blood-glucose measurement <60 mg/dL and/or symptoms believed to be associated with hypoglycemia and 2.6% of patients discontinued for this reason. Hypoglycemia was not reported for any placebo patients. Gastrointestinal Reactions In clinical trials, the incidence of gastrointestinal (GI) side effects (nausea, vomiting, constipation, dyspepsia), occurred in less than 3% of glipizide extended-release tablets-treated patients and were more common in glipizide extended-release tablets-treated patients than those receiving placebo. Dermatologic Reactions In clinical trials, allergic skin reactions, i.e., urticaria occurred in less than 1.5% of treated patients and were more common in glipizide extended-release tablets treated patients than those receiving placebo. These may be transient and may disappear despite continued use of glipizide XL; if skin reactions persist, the drug should be discontinued. Laboratory Tests Mildtomoderateelevations of ALT, LDH, alkalinephosphatase, BUN andcreatininehave been noted.Therelationship of theseabnormalitiestoglipizideisuncertain. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of glipizide extended-release tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Abdominal pain
  • Cholestatic and hepatocellular forms of liver injury accompanied by jaundice
  • Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia [see Warnings and Precautions (5.2) ] , aplastic anemia, pancytopenia
  • Hepatic porphyria and disulfiram-like reactions
  • Hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion
  • Rash
  • There have been reports of gastrointestinal irritation and gastrointestinal bleeding with use of another drug with this extended release formulation.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Inform patients of the potential adverse reactions of glipizide extended-release tablets including hypoglycemia.
  • Explain the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development to patients and responsible family members.
  • Also inform patients about the importance of adhering to dietary instructions, of a regular exercise program, and of regular testing of glycemic control.
  • Inform patients that glipizide extended-release tablets should be swallowed whole.
  • Inform patients that they should not chew, divide or crush tablets.
  • Pregnancy Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1) ].
  • Lactation Advise breastfeeding women taking glipizide extended-release tablets to monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, hypothermia, excessive sleepiness, poor feeding, seizures) [see Use in Specific Populations (8.2) ].

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS Glipizide Extended-Release Tablets 2.5 mg are white to off-white, round, biconvex film- coated tablets imprinted with ‘G’ over ‘2.5’ on one side with black ink.
  • Glipizide Extended-Release Tablets 5 mg are white to off-white, round, biconvex film- coated tablets imprinted with ‘G 5’ on one side with black ink.
  • Glipizide Extended-Release Tablets 10 mg are white to off-white, round, biconvex film-coated tablets imprinted with ‘G’ over ‘10’ with black ink.
  • Tablets: 2.5 mg, 5 mg, 10 mg ( 3 ).

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Glipizide Extended-Release Tablets, 10 mg are white to off-white, round, biconvex film-coated tablets imprinted with ‘G’ over ‘10’ with black ink.
  • Bottles of 90 NDC 60760-793-90 Recommended Storage:
  • The tablets should be protected from moisture and humidity.
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

  • Glipizide extended-release tablets (glipizide) is an oral sulfonylurea.
  • The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea.
  • The molecular formula is C 21 H 27 N 5 O 4 S; the molecular weight is 445.55; the structural formula is shown below:
  • Glipizide is a white or almost white crystalline odorless powder with a pKa of 5.9.
  • It is insoluble in water and alcohols, but soluble in
  • 0.1 N NaOH; it is freely soluble in dimethylformamide.
  • Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are:
  • acetyltributyl citrate, ammonium hydroxide, hydroxyethyl cellulose, hydroxypropyl cellulose, iron oxide black, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer (1:1), polyethylene glycol, propylene glycol and shellac glaze in ethanol.
  • System Components and Performance Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or 10 mg of glipizide.
  • Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

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Details

Made bySt. Mary's Medical Park Pharmacy
Active substanceGlipizide
Used inDigestion, stomach, diabetes and nutrition
Strength10 mg
FormTablet, Extended Release
RouteOral
Packs90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
NDC60760-793

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

84 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Glipizide5 mgPrescription onlyTablet Actavis Pharma, Inc. · GlipizideGlipizide10 mgPrescription onlyTablet Actavis Pharma, Inc. · GlipizideGlipizide5 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · GlipizideGlipizide10 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · GlipizideGlipizide5 mgPrescription onlyTablet Major Pharmaceuticals · GlipizideGlipizide2.5 mgPrescription onlyTablet, Extended Release Northstar Rx LLC. · Glipizide

See every product with Glipizide