Glucotrol XL - Side Effects & Drug Interactions

[Glipizide]

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 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 report-ed 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:




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


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