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GLUCOTROL® XL Highlights (glipizide extended release tablets)


These highlights do not include all the information needed to use GLUCOTROL XL safely and effectively. See full prescribing information for GLUCOTROL XL.

GLUCOTROL XL® (glipizide) extended release tablets, for oral use
Initial U.S. Approval: 1994


GLUCOTROL XL is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)

Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis (1)


  • 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).


Tablets: 2.5 mg, 5 mg, 10 mg (3).


  • Known hypersensitivity to glipizide or any of the product's ingredients (4).
  • Hypersensitivity to sulfonamide derivatives (4).


  • 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 GLUCOTROL XL or any other anti-diabetic drug (5.4).


Most common adverse reactions (incidence > 3%) are dizziness, diarrhea, nervousness, tremor, hypoglycemia and flatulence (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or


  • Certain medications may affect glucose metabolism, requiring GLUCOTROL XL dose adjustment and close monitoring of blood glucose (7.1).
  • Miconazole: Monitor patients closely. Severe hypoglycemia can occur when GLUCOTROL and oral miconazole are used concomitantly (7.2, 12.3).
  • Fluconazole: Monitor patients closely. An increase in GLUCOTROL AUC was seen after fluconazole administration (7.3, 12.3).
  • Colesevelam: GLUCOTROL XL should be administered at least 4 hours prior to colesevelam (7.4, 12.3).


  • Geriatric, Hepatically Impaired Patients: At risk for hypoglycemia with GLUCOTROL XL. Use caution in dose selection and titration, and monitor closely (8.5, 8.6).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 8/2018

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or