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Side Effects & Drug Interactions
ADVERSE REACTIONS
In placebo-controlled, double-blind, and open-label clinical studies, 1483 adults and children 12 years and older received treatment with triamcinolone acetonide aqueous nasal spray. These patients were treated for an average duration of 51 days. In the controlled trials (2-5 weeks duration) from which the following adverse reaction data are derived, 1394 patients were treated with Nasacort AQ Nasal Spray for an average of 19 days. In a long-term, open-label study, 172 patients received treatment for an average duration of 286 days. Adverse events occurring at an incidence of 2% or greater and more common among Nasacort AQ-treated patients than placebo-treated patients in controlled adult clinical trials were: 
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A total of 602 children 6 to 12 years of age were studied in 3 double-blind, placebo-controlled clinical trials. Of these, 172 received 110 mcg/day and 207 received 220 mcg/day of Nasacort AQ Nasal Spray for two, six, or twelve weeks. The longest average durations of treatment for patients receiving 110 mcg/day and 220 mcg/day were 76 days and 80 days, respectively. Only 1% of those patients treated with Nasacort AQ were discontinued due to adverse experiences. No patient receiving 110 mcg/day discontinued due to a serious adverse event and one patient receiving 220 mcg/day discontinued due to a serious event that was considered not drug related. Overall, these studies found the adverse experience profile for Nasacort AQ to be similar to placebo. A similar adverse event profile was observed in pediatric patients 6-12 years of age as compared to older children and adults with the exception of epistaxis which occurred in less than 2% of the pediatric patients studied. Adverse events occurring at an incidence of 2% or greater and more common among adult patients treated with placebo than Nasacort AQ were: headache, and rhinitis. In children aged 6 to 12 years these events included: asthma, epistaxis, headache, infection, otitis media, sinusitis, and vomiting. In clinical trials, nasal septum perforation was reported in one adult patient although relationship to Nasacort AQ Nasal Spray has not been established. In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but acute systemic adverse experiences are unlikely. (See OVERDOSAGE.)
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