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:
GLUCOTROL XL (%) 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 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.
Post-Marketing Experience
The following adverse events have been reported in post-marketing surveillance:
Gastrointestinal
abdominal pain
Hepatobiliary
Cholestatic and hepatocellular forms of liver injury accompanied by jaundice have been reported rarely in association with glipizide; GLUCOTROL XL should be discontinued if this occurs.
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 (see PRECAUTIONS), 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 modera