Side Effects of Glucotrol (glipizide)

Glucotrol (glipizide) is a sulfonylurea used to treat patients with type 2 diabetes.

Insulin is a hormone made in the pancreas that, when released into the blood, causes cells in the body to remove glucose from the blood and reduces glucose production by the liver.

Patients with type 2 diabetes have high glucose levels in their blood because their cells are resistant to the glucose-removing effect of insulin, and their liver produces too much glucose. Additionally, the pancreas is unable to produce the increased amounts of insulin needed to overcome the resistance.

Glucotrol stimulates the pancreas to produce more insulin and reduces blood glucose. It is not a cure for diabetes.

Common side effects of Glucotrol include:

• headache,
• dizziness,
• nausea,
• vomiting,
• diarrhea,
• heartburn,
• gas,
• skin rashes (itching, hives, or a measles-like rash).

Serious side effects of Glucotrol include:

• hepatitis,
• jaundice (yellowing of the skin and eyes),
• low blood sodium (hyponatremia),
• low blood sugar (hypoglycemia).

Glucotrol interacts with alcohol, which can prolong its action. It can also interact with cholestyramine and fluconazole, among many other drugs, affecting glucose levels and the effects of Glucotrol.

Pregnant women are not recommended to use Glucotrol for routine diabetes management. Insulin is preferred in pregnancy. If Glucotrol is used during pregnancy, it should be stopped at least 1 month before the expected delivery date.

Glucotrol is not found in breast milk, but the risk of hypoglycemia in the nursing infant should be considered when deciding whether to discontinue the drug or breastfeeding.

Side Effects of Glucotrol (glipizide)

Side effects include:

Skin rashes can occur and cause itching, hives, or a measles-like rash.

Rare but serious side effects include:

• hepatitis,
• jaundice,
• low blood sodium concentration.

Glipizide can also cause hypoglycemia, especially when combined with other glucose-reducing agents.

Glucotrol (glipizide) side effects list for healthcare professionals

In controlled studies, the frequency of serious adverse reactions reported was very low. Of 702 patients, 11.8% reported adverse reactions, and Glucotrol was discontinued in only 1.5% of cases.

Hypoglycemia

• See prescribing information.

Gastrointestinal

• Gastrointestinal disturbances are the most common reactions. Nausea and diarrhea occur in about 1 in 70 patients, while constipation and gastralgia occur in about 1 in 100 patients. These symptoms are dose-related and may disappear when the dosage is divided or reduced.

Dermatologic

• Allergic skin reactions, including rashes, urticaria, pruritus, and eczema, have been reported in about 1 in 70 patients. These reactions may be transient and may disappear despite continued use of Glucotrol. If the reactions persist, the drug should be discontinued. Porphyria cutanea tarda and photosensitivity reactions have also been reported with sulfonylureas.

Hematologic

• Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic

• Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas. Glucotrol does not cause an accumulation of acetaldehyde after ethanol administration. The drug has an extremely low incidence of disulfiram-like alcohol reactions.

Endocrine Reactions

• Hyponatremia and the syndrome of inappropriate antidiuretic hormone secretion have been reported with sulfonylureas.

Miscellaneous

• Dizziness, drowsiness, and headache have each been reported in about 1 in 50 patients treated with Glucotrol. These symptoms are usually transient and seldom require discontinuation of therapy.

Laboratory Tests

• Laboratory test abnormalities observed with Glucotrol are similar to those of other sulfonylureas. Mild to moderate elevations of certain enzymes and compounds were noted, but they have rarely been associated with clinical symptoms.

Post-Marketing Experience

The following adverse events have been reported in post-marketing surveillance:

Hepatobiliary

• Cholestatic and hepatocellular forms of liver injury accompanied by jaundice have been reported rarely in association with glipizide. Glucotrol should be discontinued if this occurs.

Drug Interactions with Glucotrol (glipizide)

• The hypoglycemic action of sulfonylureas may be potentiated by certain drugs, including nonsteroidal anti-inflammatory agents, some azoles, and other highly protein bound drugs. When such drugs are administered with Glucotrol, the patient should be observed closely for hypoglycemia. Withdrawal of these drugs should also be closely monitored to prevent loss of control.
• Glucotrol binds differently than tolbutamide and does not interact with salicylate or dicumarol according to in vitro binding studies. However, caution must be exercised when using Glucotrol with these drugs, as the clinical implications are uncertain.
• Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include thiazides, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. Close observation is necessary when administering these drugs to patients receiving Glucotrol, as loss of control or hypoglycemia may occur.
• An interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. The interaction with other forms of miconazole is unknown.
• A placebo-controlled crossover study demonstrated the effect of Diflucan (fluconazole) on Glucotrol. The mean percentage increase in Glucotrol’s absorption after fluconazole administration was 56.9%. Colesevelam can also affect the pharmacokinetics of glipizide ER in healthy volunteers, reducing its absorption by 12% and 13% for AUC0-∞ and Cmax, respectively. Administering Glucotrol at least 4 hours prior to colesevelam can mitigate this effect.

Summary

Glucotrol (glipizide) is a sulfonylurea used to treat patients with type 2 diabetes. It reduces blood glucose levels by stimulating insulin production. Common side effects include headache, dizziness, nausea, vomiting, diarrhea, heartburn, gas, and skin rashes. It is not recommended for routine diabetes management in pregnant women and is not found in breast milk.