The adverse events reported in clinical trials with NASACORT most commonly involved the mucous membranes of the nose and throat. The following terminologies have been used in order to classify the occurrence of adverse reactions: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥ 1/1,000 and < 1/100; Rare ≥ 1/10,000 and <1/1,000; Very rare < 1/10,000 and not known (cannot be estimated from the 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).
Not known: insomnia.
Nervous system disorders:
Common: headache. Not known: dizziness, alterations of taste and smell.
Not known: cataract, glaucoma, increased ocular pressure.
Respiratory, thoracic and mediastinal disorders:
Common: bronchitis, epistaxis, cough. Rare: nasal septum perforations. Not known: nasal irritation, dry mucous membrane, nasal congestion, sneezing, dyspnoea.
Common: dyspepsia, tooth disorder. Not known: nausea.
General disorders and administration site conditions:
Not known: fatigue.
Not known: decreased blood cortisol.
Reduction of growth velocity has been observed in children during a post-marketing clinical trial with NASACORT.
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods. Growth retardation has been reported in children receiving intranasal steroids.
Additional Adverse Reactions for Children 2 to 5 years: Respiratory, thoracic and mediastinal disorders
: Common: Pharyngolaryngeal pain.
Skin and subcutaneous tissue disorders
: Common: Excoriation.
: Common: Upper abdominal pain, diarrhea.