Budesonide Inhalation Suspension Side Effects

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 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 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.

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.

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 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.

Post-marketing Experience

The following adverse reactions have been reported during post-approval use of 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 Budesonide Inhalation Suspension.

Endocrine disorders: symptoms of hypocorticism and hypercorticism [see Warnings and Precautions (5.5)]  

Eye disorders: cataracts, glaucoma, increased intraocular pressure [see Warnings and Precautions (5.9)]

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 (4) and Warnings and Precautions (5.10)]  

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 Budesonide Inhalation Suspension [see Warnings and Precautions (5.8) and Use In Specific Populations, Pediatric Use (8.4)].

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