Glipizide ER Side Effects
Please note - some side effects for Glipizide ER may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Glipizide ER Side Effects - for the Professional
Applies to: oral tablet, film coated, extended release
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.
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 tablets and glipizide tablets, 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 tablet-treated patients include:
|Glipizide ER (%)||Placebo (%)|
The following adverse experiences occurred with an incidence of less than 3% in glipizide extended-release tablet-treated patients:
Body as a whole–pain
Nervous system–insomnia, paresthesia, anxiety, depression and hypesthesia
Gastrointestinal–nausea, dyspepsia, constipation and vomiting
Musculoskeletal–arthralgia, leg cramps and myalgia
Skin–sweating and pruritus
Special senses–blurred vision
Other adverse experiences occurred with an incidence of less than 1% in glipizide extended-release tablet-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
Although these adverse experiences occurred in patients treated with glipizide extended-release tablets, 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 glipizide extended-release tablets, 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 glipizide extended-release tablets:
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.
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