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SIDE EFFECTS Immediate Release Tablets

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

Hypoglycemia: See PRECAUTIONS and OVERDOSAGE.

Gastrointestinal: Gastrointestinal disturbances are the most common reactions. Gastrointestinal complaints were reported with the following approximate incidence: nausea and diarrhea, one in seventy; constipation and gastralgia, one in one hundred. They appear to be dose-related and may disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with sulfonylureas; glipizide should be discontinued if this occurs.

Dermatologic: Allergic skin reactions including erythema, morbilliform or maculopapular eruptions, urticaria, pruritus, and eczema have been reported in about one in seventy patients. These may be transient and may disappear despite continued use of glipizide; if skin reactions persist, the drug should be discontinued. Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.

Miscellaneous: Dizziness, drowsiness, and headache have each been reported in about one in fifty patients treated with glipizide. They are usually transient and seldom require discontinuance of therapy.

Extended Release Tablets

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 glipizide 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.

Only 3.4% of patients receiving glipizide 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 glipizide extended-release and glipizide, 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 glipizide extended-release-treated patients include:

TABLE 1 Adverse Effect Glucotrol XL (%) Placebo (%) (N=278) (N=69) Asthenia 10.1 13.0 Headache 8.6 8.7 Dizziness 6.8 5.8 Nervousness 3.6 2.9 Tremor 3.6 0.0 Diarrhea 5.4 0.0 Flatulence 3.2 1.4

The following adverse experiences occurred with an incidence of less than 3% in glipizide extended-release-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 glipizide extended-release-treated patients:

Body as a Whole: Chills. Nervous System: Hypertonia, confusion, vertigo, somnolence, gait abnormality and decreases 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 glipizide extended-release, 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.

Immediate Release Tablets

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

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 this 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.

The above is quoted from the website linked below.

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