Systemic and intranasal corticosteroids use may result in the following:
- Epistaxis, Candida albicans infection, nasal septum perforation, and impaired wound healing [see WARNINGS AND PRECAUTIONS].
- Hypersensitivity Including Anaphylaxis [see WARNINGS AND PRECAUTIONS].
- Immunosuppression [see WARNINGS AND PRECAUTIONS].
- Hypercorticism and Adrenal Suppression [see WARNINGS AND PRECAUTIONS].
- Growth Effect [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].
- Glaucoma and Cataracts [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The incidence of common adverse reactions in Table 1 is based upon two U.S. and five non-U.S. controlled clinical trials in 1,526 patients with seasonal or perennial rhinitis in adults and children ≥ 6 years treated with RHINOCORT AQUA (budesonide) Nasal Spray at doses up to 400 mcg once daily for 3-6 weeks. This population included 745 females and 781 males with a mean age of 31 years (range of 6-85 years, 349 were 6 < 18 years). The racial distribution of patients receiving RHINOCORT AQUA (budesonide) Nasal Spray was 93% white, 3% black and 4% other. Table 1 describes adverse reactions occurring at an incidence of 2% or greater and more commonly among RHINOCORT AQUA (budesonide) Nasal Spray-treated patients than in placebo-treated patients in controlled clinical trials.
Table 1. Adverse Reactions occurring at an incidence ≥ 2% and more commonly than placebo in the RHINOCORT AQUA (budesonide) Nasal Spray group in patients 6 years and older
|Adverse Event|| RHINOCORT
AQUA Nasal Spray
|Nasal Irritation||2%||< 1%|
A similar adverse reaction profile was observed in the subgroup of pediatric patients 6 to 12 years of age. These patients are included in Table 1.
Two to three percent (2-3%) of patients in clinical trials discontinued because of adverse reactions. Systemic corticosteroid side effects were not reported during controlled clinical studies with RHINOCORT AQUA (budesonide) Nasal Spray.
If recommended doses are exceeded, or if individuals are particularly sensitive, symptoms of hypercorticism, ie, Gushing's Syndrome, and adrenal suppression could occur.
The following adverse reactions have been reported during post-approval use of RHINOCORT AQUA (budesonide) Nasal Spray. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune system disorders: immediate and delayed hypersensitivity reactions (including anaphylactic reaction, urticaria, rash, dermatitis, angioedema and pruritus), [see WARNINGS AND PRECAUTIONS and CONTRAINDICATIONS]
Eye disorders: glaucoma, increased intraocular pressure, cataracts [see WARNINGS AND PRECAUTIONS]
Respiratory, thoracic, and mediastinal disorders: nasal septum perforation, anosmia, pharynx disorders (throat irritation, throat pain, swollen throat, burning throat, and itchy throat), and wheezing
Cardiac disorders: palpitations
Musculoskeletal and connective tissue disorders: growth suppression [see WARNINGS AND PRECAUTIONS and Use In Specific Populations]