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 marketing experience for inhaled budesonide include: immediate and delayed hypersensitivity reactions including rash, contact dermatitis, angioedema, and bronchospasm; symptoms of hypocorticism and hypercorticism; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety, and psychosis; and bone disorders including avascular necrosis of the femoral head and osteoporosis.
DRUG INTERACTIONS
In clinical studies, concurrent administration of budesonide and other drugs commonly used in the treatment of asthma has not resulted in an increased frequency of adverse events. The main route of metabolism of budesonide, as well as other corticosteroids, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a potent inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of other known inhibitors of CYP3A4 (eg, itraconazole, clarithromycin, erythromycin, etc.) may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Care should be exercised when budesonide is coadministered with long-term ketoconazole and other known CYP3A4 inhibitors. Omeprazole did not have effects on the pharmacokinetics of oral budesonide, while cimetidine, primarily an inhibitor of CYP1A2, caused a slight decrease in budesonide clearance and a corresponding increase in its oral bioavailability.
www.rxlist.com