The adverse events reported in clinical trials with NASACORT most commonly involved the mucous membranes of the nose and throat.
The following frequency rating has been used, when applicable: Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1% and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01% and not known (frequency cannot be estimated from available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The most frequent adverse reactions in adults and children ≥6 years of age and older were: Infections and infestations: Common: flu syndrome, pharyngitis, rhinitis.
Immune system disorders: Not known: hypersensitivity (including rash, urticaria, pruritus and facial oedema).
Psychiatric disorders: Not known: insomnia.
Nervous system disorders: Common: headache.
Not known: dizziness, alterations of taste and smell.
Eye disorders: Not known: chorioretinopathy, cataract, glaucoma, increased ocular pressure, blurred vision.
Respiratory, thoracic and mediastinal disorders: Common: bronchitis, epistaxis, cough.
Rare: nasal septum perforations.
Not known: Nausea, nasal irritation, dry mucous membrane, nasal congestion, sneezing, dyspnoea.
Gastrointestinal disorders: Common: dyspepsia, tooth disorder.
Not known: nausea.
General disorders and administration site conditions: Not known: fatigue.
Investigations: Not known: decreased blood cortisol.
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: (See table.)
Click on icon to see table/diagram/image
Children 4 to 12 years of age (=622) were studied in 3 controlled clinical trials. Of these, 179 received 110 mcg/day and 215 received 220 mcg/day Nasacort AQ Nasal Spray in two, six, or twelve weeks trials. The longest average duration of treatment for patients receiving 110 mcg/day was 76.3 days and 79.6 days for those receiving 220 mcg/day.
The experienced adverse reactions, with the exception of epistaxis (in adults), and the exception of nasal congestion and sneezing (in children) were reported at approximately the same or lower incidence as placebo treated patients. Only 1% of the patients in the controlled trials discontinued treatment (e.g. pharyngitis, headache).
In children, 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.
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 4 to 12 years were epistaxis (3.1%), rhinitis (1.4%) headache. (1.2%).
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.)