ADVERSE REACTIONS
The following adverse reactions were reported in pediatric patients treated with PULMICORT RESPULES.
The incidence of common adverse reactions is based on three double-blind, placebo-controlled, 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 (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 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.
Adverse Events with ≥ 3% Incidence Reported by Patients on PULMICORT RESPULES
|
Adverse Events
|
Vehicle
Placebo
(n=227)
%
|
PULMICORT RESPULES
Total Daily Dose
|
|
0.25 mg
(n=178)
%
|
0.5 mg
(n=223)
%
|
1 mg
(n=317)
%
|
|
Respiratory System Disorder
|
|
Respiratory Infection
|
36
|
34
|
35
|
38
|
|
Rhinitis
|
9
|
7
|
11
|
12
|
|
Coughing
|
5
|
5
|
9
|
8
|
|
Resistance Mechanism Disorders
|
|
Otitis Media
|
11
|
12
|
11
|
9
|
|
Viral Infection
|
3
|
4
|
5
|
3
|
|
Moniliasis
|
2
|
4
|
3
|
4
|
|
Gastrointestinal System Disorders
|
|
Gastroenteritis
|
4
|
5
|
5
|
5
|
|
Vomiting
|
3
|
2
|
4
|
4
|
|
Diarrhea
|
2
|
4
|
4
|
2
|
|
Abdominal Pain
|
2
|
3
|
2
|
3
|
|
Hearing and Vestibular Disorders
|
|
Ear Infection
|
4
|
2
|
4
|
5
|
|
Platelet, Bleeding and Clotting
Disorders
|
|
Epistaxis
|
1
|
2
|
4
|
3
|
|
Vision Disorders
|
|
Conjunctivitis
|
2
|
<1
|
4
|
2
|
|
Skin and Appendages Disorders
|
|
Rash
|
3
|
<1
|
4
|
2
|
The table above shows all adverse events with an incidence of 3% or more in at least one active treatment group where the incidence was higher with PULMICORT RESPULES than with placebo.
The following adverse events occurred with an incidence of 3% or more in at least one PULMICORT RESPULES group where the incidence was equal to or less than that of the placebo group: fever, sinusitis, pain, pharyngitis, bronchospasm, bronchitis, and headache.
Incidence 1% to ≤3% (by body system)
The information below includes all adverse events with an incidence of 1 to ≤3%, in at least one PULMICORT RESPULES treatment group where the incidence was higher with PULMICORT RESPULES than with placebo, regardless of relationship to treatment.
Body as a whole: allergic reaction, chest pain, fatigue, flu-like disorder
Respiratory system: stridor
Resistance mechanisms: herpes simplex, external ear infection, infection
Central & peripheral nervous system: dysphonia, hyperkinesia
Skin & appendages: eczema, pustular rash, pruritus
Hearing & vestibular: earache
Vision: eye infection
Psychiatric: anorexia, emotional lability
Musculoskeletal system: fracture, myalgia
Application site: contact dermatitis
Platelet, bleeding & clotting: purpura
White cell and resistance: cervical lymphadenopathy
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.
Cases of growth suppression have been reported for inhaled corticosteroids including post-marketing reports for PULMICORT RESPULES (see PRECAUTIONS, Pediatric Use).
Less frequent adverse events (<1%) reported in the published literature, long-term, open-label clinical trials, or from worldwide marketing experience with any formulation of inhaled budesonide include: immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema, and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety, and psychosis; and bone disorders including avascular necrosis of the femoral head and osteoporosis.
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