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.The information below includes all adverse reactions by system organ class with an incidence of 1 to < 3%, in at least one Budesonide Inhalation Suspension treatment group where the incidence was higher with Budesonide Inhalation Suspension than with placebo, regardless of relationship to treatment.The incidence of reported adverse events was similar between the 447 Budesonide Inhalation Suspension-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 Budesonide Inhalation Suspension. In the subgroup of children age 6 months to 2 years (n = 21) receiving a total daily dose of Budesonide Inhalation Suspension equivalent to 0.25 mg (n=5), 0.5 mg (n=5), 1 mg (n=8), or placebo (n=3), the mean change from baseline in ACTH-stimulated cortisol levels showed a decline in peak stimulated cortisol at 12 weeks compared to an increase in the placebo group. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated (see the respective package inserts for complete VZIG and IG prescribing information). Especially tell your healthcare provider if your child takes:Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.Know the medicines your child takes. The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown. If you have any questions about Budesonide Inhalation Suspension, ask your healthcare provider or pharmacist.Budesonide Inhalation Suspension is an inhaled corticosteroid medicine. The changes from baseline to Weeks 0 to 12 in nighttime asthma symptom scores are shown in Figure 1. Do not give Budesonide Inhalation Suspension to other people, even if they have the same symptoms that you have. Some brands may be opened and the contents sprinkled onto a spoonful of soft, cool applesauce in a clean container. OTHER NAME(S): Budesonide ERBudesonide Capsule, Delayed And Extended ReleaseRead the Patient Information Leaflet if available from your If you are using the extended-release tablets, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. These findings support that the use of Budesonide Inhalation Suspension in infants 6 to 12 months of age may result in systemic effects and are consistent with findings of growth suppression in other studies with inhaled corticosteroids.Controlled clinical studies have shown that inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. If exposure to such a person occurs, and the child has not had chicken pox or been properly vaccinated, a physician should be consulted without delay. Statistically significant decreases in nighttime and daytime symptom scores of asthma were observed at Budesonide Inhalation Suspension doses of 0.25 mg once daily (one study), 0.25 mg twice daily, and 0.5 mg twice daily compared to placebo. The clinical relevance of these models is not certain.Pre-treatment with budesonide administered as 1600 mcg daily (800 mcg twice daily) via a dry powder inhaler for 2 weeks reduced the acute (early-phase reaction) and delayed (late-phase reaction) decrease in FEVThe effects of Budesonide Inhalation Suspension on the hypothalamic-pituitary-adrenal (HPA) axis were studied in three, 12 week, double-blind, placebo-controlled studies in 293 pediatric patients, 6 months to 8 years of age, with persistent asthma. The estimated oral daily dose of budesonide from breast milk to the infant is approximately 0.007 and 0.014 mcg/kg/day for the two dose regimens used in this study, which represents approximately 0.3% to 1% of the dose inhaled by the mother. Ultrasonic nebulizers are not suitable for the adequate administration of Budesonide Inhalation Suspension and, therefore, are not recommended. The model included terms for the respective changes from baseline as the dependent variable and terms for treatment, center and treatment by center interaction as exploratory variables (see Figures 1 to 3).Figure 1: A 12 Week Trial in Pediatric Patients Not on Inhaled Corticosteroid Therapy Prior to Study Entry. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. Grapefruit can increase the chance of side effects with this medicine. Inflammation in the lungs can lead to asthma symptoms. These patients should also be instructed to carry a medical identification card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack.Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Budesonide Inhalation Suspension. Budesonide Inhalation Suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Particular care should be taken in observing patients post-operatively or during periods of stress for evidence of inadequate adrenal response.