Glipizide Side Effects
Glipizide Side Effects
DrugLib.com
ADVERSE REACTIONS
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 sections.
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-treated patients include:
Glipizide (%) Placebo (%)
(N=278) (N=69)
Adverse Effect
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-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-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 glipizide, 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.
The following are adverse experiences reported with immediate release glipizide and other sulfonylureas, but have not been observed with glipizide:
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.
Page last updated: 2006-02-03
All Rights reserved - Copyright DrugLib.com, 2006-2009
