Systemic and inhaled corticosteroid use may result in the following:
- Candida albicans infection [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions including anaphylaxis [see WARNINGS AND PRECAUTIONS]
- Immunosuppression [see WARNINGS AND PRECAUTIONS]
- Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
- Reduction in bone mineral density [see WARNINGS AND PRECAUTIONS]
- Growth effects in pediatric patients [see WARNINGS AND PRECAUTIONS and Use in Specific Populations, Pediatric Use]
- Glaucoma, increased intraocular pressure and cataracts [see WARNINGS AND PRECAUTIONS]
- Eosinophilic conditions and Churg-Strauss syndrome [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 is based on three double-blind, placebo-controlled, randomized U.S. clinical trials in which 945 patients, 12 months to 8 years of age, (98 patients ≥ 12 months and < 2 years of age; 225 patients ≥ 2 and < 4 years of age; and 622 patients ≥ 4 and ≤ 8 years of age) were treated with PULMICORT RESPULES (budesonide inhalation suspension) (0.25 to 1 mg total daily dose for 12 weeks) or vehicle placebo. The incidence and nature of adverse events reported for PULMICORT RESPULES (budesonide inhalation suspension) was comparable to that reported for placebo. The following table shows the incidence of adverse events in U.S. controlled clinical trials, regardless of relationship to treatment, in patients previously receiving bronchodilators and/or inhaled corticosteroids. This population included a total of 605 male and 340 female patients and 78.4% were Caucasian, 13.8% African American, 5.5% Hispanic and 2.3% Other.
Table 1 : Adverse Reactions occurring at an incidence of ≥ 3% in at least one active treatment group where the incidence was higher with PULMICORT RESPULES (budesonide inhalation suspension) than placebo
|PULMICORT RESPULES Total Daily Dose|
|Respiratory System Disorder|
|Resistance Mechanism Disorders|
|Gastrointestinal System Disorders|
|Hearing and Vestibular Disorders|
|Platelet, Bleeding and Clotting Disorders|
|Skin and Appendages Disorders|
The information below includes all adverse reactions by system organ class with an incidence of 1 to < 3%, in at least one PULMICORT RESPULES (budesonide inhalation suspension) treatment group where the incidence was higher with PULMICORT RESPULES (budesonide inhalation suspension) than with placebo, regardless of relationship to treatment.
Blood and lymphatic system disorders: cervical lymphadenopathy
Ear and labyrinth disorders: earache
General disorders and administration site conditions: fatigue, flu-like disorder
Immune system disorders: allergic reaction
Infections and infestations: eye infection, herpes simplex, external ear infection, infection
Injury, poisoning and procedural complication: fracture
Metabolism and nutrition disorders: anorexia
Musculoskeletal and connective tissue disorders: myalgia
Nervous system disorders: hyperkinesia
Psychiatric disorders: emotional lability
Respiratory, thoracic, and mediastinal disorders: chest pain, dysphonia, stridor
Skin and subcutaneous tissue disorders: contact dermatitis, eczema, pustular rash, pruritus, purpura
The incidence of reported adverse events was similar between the 447 PULMICORT RESPULES-treated (mean total daily dose 0.5 to 1 mg) and 223 conventional therapy-treated pediatric asthma patients followed for one year in three open-label studies.
The following adverse reactions have been reported during post-approval use of PULMICORT RESPULES (budesonide inhalation suspension) . 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. Some of these adverse reactions may also have been observed in clinical studies with PULMICORT RESPULES (budesonide inhalation suspension) .
Endocrine disorders: symptoms of hypocorticism and hypercorticism [see WARNINGS AND PRECAUTIONS]
Eye disorders: cataracts, glaucoma, increased intraocular pressure [see WARNINGS AND PRECAUTIONS]
General disorders and administration site conditions: fever, pain
Immune system disorders: immediate and delayed hypersensitivity reactions including, anaphylaxis, angioedema, bronchospasm, rash, contact dermatitis, and urticaria [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
Infection and Infestation: sinusitis, pharyngitis, bronchitis
Musculoskeletal and connective tissue disorders: avascular necrosis of the femoral head, osteoporosis, growth suppression
Nervous system disorders: headache
Psychiatric disorders: psychiatric symptoms including psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, and anxiety
Respiratory, thoracic, and mediastinal disorders: cough, dysphonia and throat irritation
Skin and subcutaneous tissue disorders: skin bruising, facial skin irritation
Cases of growth suppression have been reported for inhaled corticosteroids including post-marketing reports for PULMICORT RESPULES [see WARNINGS AND PRECAUTIONS and Use In Specific Populations, Pediatric Use].