Glucotrol XL Side Effects

Generic Name: glipizide

Please note - some side effects for Glucotrol XL may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Glucotrol XL - for the Consumer

Glucotrol XL Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Glucotrol XL Extended-Release Tablets:

Diarrhea; dizziness; gas; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; skin redness; dizziness); confusion; dark urine; fainting; fever, chills, or persistent sore throat; irregular heartbeat; low blood sugar symptoms (eg, anxiety, drowsiness, fast heartbeat, headache, lightheadedness, severe or persistent dizziness, tremors, unusual sweating, weakness); severe or persistent blurred vision or other vision problems; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the eyes or skin.

Glucotrol XL Side Effects - for the Professional

Glucotrol XL

In U.S. controlled studies the frequency of serious adverse experiences reported was very low and causal relationship has not been established.

The 580 patients from 31 to 87 years of age who received Glucotrol XL Extended Release Tablets in doses from 5 mg to 60 mg in both controlled and open trials were included in the evaluation of adverse experiences. All adverse experiences reported were tabulated independently of their possible causal relation to medication.

Hypoglycemia

See PRECAUTIONS and OVERDOSAGE sections.

Only 3.4% of patients receiving Glucotrol XL Extended Release Tablets had hypoglycemia documented by a blood-glucose measurement <60 mg/dL and/or symptoms believed to be associated with hypoglycemia. In a comparative efficacy study of Glucotrol XL and Glucotrol, hypoglycemia occurred rarely with an incidence of less than 1% with both drugs.

In double-blind, placebo-controlled studies the adverse experiences reported with an incidence of 3% or more in Glucotrol XL-treated patients include:

The following adverse experiences occurred with an incidence of less than 3% in Glucotrol XL-treated patients:

 

Body as a whole–pain

 

Nervous system–insomnia, paresthesia, anxiety, depression and hypesthesia

 

Gastrointestinal–nausea, dyspepsia, constipation and vomiting

 

Metabolic–hypoglycemia

 

Musculoskeletal–arthralgia, leg cramps and myalgia

 

Cardiovascular–syncope

 

Skin–sweating and pruritus

 

Respiratory–rhinitis

 

Special senses–blurred vision

 

Urogenital–polyuria

Other adverse experiences occurred with an incidence of less than 1% in Glucotrol XL-treated patients:

 

Body as a whole–chills

 

Nervous system–hypertonia, confusion, vertigo, somnolence, gait abnormality and decreased libido

 

Gastrointestinal–anorexia and trace blood in stool

 

Metabolic–thirst and edema

 

Cardiovascular–arrhythmia, migraine, flushing and hypertension

 

Skin–rash and urticaria

 

Respiratory–pharyngitis and dyspnea

 

Special senses–pain in the eye, conjunctivitis and retinal hemorrhage

 

Urogenital–dysuria

Although these adverse experiences occurred in patients treated with Glucotrol XL, a causal relationship to the medication has not been established in all cases.

There have been rare reports of gastrointestinal irritation and gastrointestinal bleeding with use of another drug in this non-deformable sustained release formulation, although causal relationship to the drug is uncertain.

In post-marketing experience of Glucotrol XL, the additional adverse reaction of abdominal pain has been reported.

The following are adverse experiences reported with immediate release glipizide and other sulfonylureas, but have not been observed with Glucotrol XL:

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. In the mouse, glipizide pretreatment did not cause an accumulation of acetaldehyde after ethanol administration. Clinical experience to date has shown that glipizide has an extremely low incidence of disulfiram-like alcohol reactions.

Endocrine Reactions

Cases of hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with glipizide and other sulfonylureas.

Laboratory Tests

The pattern of laboratory test abnormalities observed with glipizide was similar to that for other sulfonylureas. Occasional mild to moderate elevations of SGOT, LDH, alkaline phosphatase, BUN and creatinine were noted. One case of jaundice was reported. The relationship of these abnormalities to glipizide is uncertain, and they have rarely been associated with clinical symptoms.

Side Effects by Body System

General

Glipizide has been usually well tolerated. Side effects were reported in 3% to 12% of patients in clinical trials. These effects were serious enough to result in discontinuation of therapy in only 0.3% to 3% of patients.

Metabolic

Hypoglycemia, an extension of glipizide's pharmacologic effects, may be severe, protracted, refractory to glucose infusion, and, in some cases, may require diazoxide. Hypoglycemia may present as coma or disturbed consciousness. Other signs of hypoglycemia include tachycardia, tremors, and increased sweating. In one review of 19 spontaneously reported cases, the mean dose of glipizide associated with hypoglycemia was 10 mg per day. The mean age in these cases was 75 years. Two patients died, although their cases were complicated and the degree to which hypoglycemia contributed to their deaths cannot be ascertained.

Patients with renal dysfunction, liver disease, or adrenal or pituitary insufficiency may be at increased risk for hypoglycemia as are those who are elderly, debilitated, or malnourished. In addition, acute illness, lack of adherence to diet, ethanol ingestion, or strenuous exercise may precipitate hypoglycemia.

Metabolic side effects have included hypoglycemia, an extension of glipizide's pharmacologic effects. Hypoglycemia has been be severe and protracted in some cases. Fatalities have been reported. Hyponatremia, disulfiram-like reactions, and coproporphyria have also been reported. Elderly patients may be at increased risk for hypoglycemia based on case reviews demonstrating an increased proportion of severe hypoglycemic events in patients aged 60 years and older.

Hematologic

Hematologic side effects have included rare reports of leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia.

Hepatic

Hepatic side effects have included rare reports of mild elevations in alkaline phosphatase, SGOT, and SGPT. The manufacturer has noted one case of jaundice. Cholestatic jaundice and hepatitis have been reported with other sulfonylureas. Frequent monitoring of liver function tests is recommended during the initiation of glipizide therapy in patients with liver dysfunction.

Dermatologic

Dermatologic side effects have included rash in 0.5% to 1.4% of patients. Allergic skin reactions have occurred as well and included erythema, morbilliform or maculopapular eruptions, urticaria, pruritus, and eczema. Photosensitivity has been reported with other sulfonylureas.

Gastrointestinal

Gastrointestinal side effects have occurred in up to 3.7% of patients in clinical trials and included nausea, heartburn, vomiting, diarrhea, constipation, and abdominal pain. Gastrointestinal side effects have tended to be mild and transient. In postmarketing experience of the extended release product, the additional side effects of abdominal pain has been reported.

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