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Endocrine and Metabolic Fluid disturbances, weight gain, goiter, disorders of uric acid metabolism, appetite disturbances. Eye Text Continues Below
Keratitis and conjunctivitis, blepharoconjunctivitis. Gastrointestinal Diarrhea, gastrointestinal signs and symptoms, oral ulcerations, dental discomfort and pain, gastroenteritis, gastrointestinal infections, abdominal discomfort and pain, oral erythema and rashes, mouth and tongue disorders, oral discomfort and pain, tooth decay. Hepatobiliary Tract and Pancreas Cholecystitis. Lower Respiratory Lower respiratory infections. Musculoskeletal Muscle pain, arthralgia and articular rheumatism, muscle cramps and spasms, musculoskeletal inflammation. Neurological Dizziness, sleep disorders, migraines, paralysis of cranial nerves. Non-Site Specific Chest symptoms; malaise and fatigue; pain; edema and swelling; bacterial infections; fungal infections; mobility disorders; cysts, lumps, and masses. Psychiatry Mood disorders. Reproduction Bacterial reproductive infections. Skin Skin rashes, urticaria, photodermatitis, dermatitis and dermatosis, viral skin infections, eczema, fungal skin infections, pruritus, acne and folliculitis. Urology Urinary infections. Three of the 7 placebo-controlled US clinical trials were pediatric studies. A total of 592 patients 4 to 11 years were treated with FLOVENT DISKUS (doses of 50 or 100 mcg twice daily) or placebo; an additional 174 patients 4 to 11 years received FLOVENT ® ROTADISK ® (fluticasone propionate inhalation powder) at the same doses. There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults. In the first 16 weeks of a 52-week clinical trial in adult asthma patients who previously required oral corticosteroids (daily doses of 5 to 40 mg oral prednisone), the effects of FLOVENT DISKUS 500 mcg twice daily (n = 41) and 1000 mcg twice daily (n = 36) were compared with placebo (n = 34) for the frequency of reported adverse events. Adverse events, whether or not considered drug related by the investigators, reported in more than five patients in the group taking FLOVENT DISKUS and that occurred more frequently with FLOVENT DISKUS than with placebo are shown below (percent FLOVENT DISKUS and percent placebo). In considering these data, the increased average duration of exposure for patients taking FLOVENT DISKUS (105 days for FLOVENT DISKUS versus 75 days for placebo) should be taken into account. Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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