The following adverse reactions were reported in children treated with budesonide inhalation suspension. The incidence of common adverse reactions is based on 3 double-blind, placebo-controlled, US clinical trials in which 945 patients, 12 months to 8 years of age, (98 patients greater than or equal to 12 months and less than 2 years of age; 225 patients greater than or equal to 2 and less than 4 years of age; and 622 patients greater than or equal to 4 and less than or equal to 8 years of age) were treated with budesonide inhalation suspension (0.25 to 1 mg total daily dose for 12 weeks) or vehicle placebo. The incidence and nature of adverse reactions reported for budesonide inhalation suspension was comparable to that reported for placebo. The following table shows the incidence of adverse reactions in US controlled clinical trials, regardless of relationship to treatment, in patients previously receiving bronchodilators or inhaled corticosteroids. This population included a total of 605 male and 340 female patients. (See Table 2.)
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The table shows all adverse reactions with an incidence of greater than or equal to 3% in at least 1 active treatment group where the incidence was higher with budesonide inhalation suspension than with placebo.
The following adverse reactions occurred with an incidence of greater than or equal to 3% in at least 1 budesonide inhalation suspension group where the incidence was equal to or less than that of the placebo group: Fever, sinusitis, pain, pharyngitis, bronchospasm, bronchitis, and headache.
Adverse reaction incidence of 1% to less than or equal to 3% (by body system) for inhalation suspension: The information below includes all adverse reactions with an incidence of 1 to less than or equal to 3%, in at least 1 budesonide inhalation suspension treatment group where the incidence was higher with budesonide inhalation suspension than with placebo, regardless of relationship to treatment.
CNS: Dysphonia; hyperkinesias.
Dermatologic: Eczema; pustular rash; pruritus; contact dermatitis.
Hematologic: Purpura; cervical lymphadenopathy.
Musculoskeletal: Fracture; myalgia.
Ophthalmic: Eye infection.
Psychiatric: Anorexia; emotional lability.
Special senses: Earache.
Miscellaneous: Allergic reaction; chest pain; fatigue; flu-like disorder; herpes simplex; external ear infection; infection.