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Side Effects & Drug Interactions
ADVERSE REACTIONS
The incidence of common adverse events in Table 1 is based upon 7 placebo-controlled US clinical trials in which 1,243 patients (509 female and 734 male adolescents and adults previously treated with as-needed bronchodilators and/ or inhaled corticosteroids) were treated with FLOVENT Inhalation Aerosol (doses of 88 to 440 mcg twice daily for up to 12 weeks) or placebo.
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Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in groups treated with FLOVENT Inhalation Aerosol and were more common than in the placebo group. In considering these data, differences in average duration of exposure should be taken into account. These adverse reactions were mostly mild to moderate in severity, with 2% of patients discontinuing the studies because of adverse events. Rare cases of immediate and delayed hypersensitivity reactions, including urticaria and rash and other rare events of angioedema and bronchospasm, have been reported. Systemic glucocorticoid side effects were not reported during controlled clinical trials with FLOVENT Inhalation Aerosol. If recommended doses are exceeded, however, or if individuals are particularly sensitive, symptoms of hypercorticism, e. g., Cushing syndrome, could occur. Other adverse events that occurred in these clinical trials using FLOVENT Inhalation Aerosol with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were: Ear, Nose, and Throat: Pain in nasal sinus( es), rhinitis. Eye: Irritation of the eye( s). Gastrointestinal
Nausea and vomiting, diarrhea, dyspepsia and stomach disorder. Miscellaneous Fever. Mouth and Teeth
Dental problem. Musculoskeletal
Pain in joint, sprain/ strain, aches and pains, pain in limb. Page: 1 | 2 | 3 | Next >>
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