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Side Effects & Drug Interactions
ADVERSE REACTIONS
The following incidence of common adverse experiences is based upon 7 placebo-controlled US clinical trials in which 1176 pediatric, adolescent, and adult patients (466 females and 710 males) previously treated with as-needed bronchodilators and/or inhaled corticosteroids were treated with fluticasone propionate inhalation powder (doses of 50 to 500 mcg twice daily for up to 12 weeks) or placebo. 
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The table above includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in any of the fluticasone propionate inhalation powder groups 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 rash and other rare events of angioedema and bronchospasm, have been reported. Other adverse events that occurred in these clinical trials using fluticasone propionate inhalation powder with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were: Cardiovascular Palpitations. Drug Interaction, Overdose, and Trauma Soft tissue injuries, contusions and hematomas, wounds and lacerations, postoperative complications, burns, poisoning and toxicity, pressure-induced disorders. Ear, Nose, and Throat Ear signs and symptoms; rhinorrhea/postnasal drip; hoarseness/dysphonia; epistaxis; tonsillitis; nasal signs and symptoms; laryngitis; unspecified oropharyngeal plaques; otitis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction. Page: 1 | 2 | 3 | 4 | Next >>
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