Budesonide Inhalation Suspension (Page 2 of 7)


Systemic and inhaled corticosteroid use may result in the following:

  • Candida albicans Infection [see Warnings and Precautions (5.1)]
  • Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.3)]
  • Immunosuppression [see Warnings and Precautions (5.4)]
  • Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.6)]
  • Reduction in Bone Mineral Density [see Warnings and Precautions (5.7)]
  • Growth Effects in Pediatric Patients [see Warnings and Precautions (5.8), Use in Specific Populations (8.4)]
  • Glaucoma, Increased Intraocular Pressure and Cataracts [see Warnings and Precautions (5.9)]
  • Eosinophilic Conditions and Churg-Strauss Syndrome [see Warnings and Precautions (5.11)]

6.1 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 ≥2and <4 years of age; and 622 patients ≥4and ≤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.

Table 1: Adverse Reactions occurring at an incidence of ≥3% in at least one active treatment group where the incidence was higher with Budesonide Inhalation Suspension than placebo
Adverse Events

Vehicle Placebo



Budesonide Inhalation Suspension Total Daily Dose

0.25 mg



0.5 mg



1 mg



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 Disorder
Epistaxis 1 2 4 3
Vision Disorders
Conjunctivitis 2 <1 4 2
Skin and Appendages Disorders
Rash 3 <1 4 2

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:


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:


Metabolism and Nutrition Disorders:


Musculoskeletal and Connective Tissue Disorders:


Nervous System Disorders:


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.

6.2 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 (5.6)]

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), 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:


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), Use in Specific Populations (8.4)].


7.1 Inhibitors of Cytochrome P450 3A4

The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide. Caution should be exercised when considering the coadministration of budesonide inhalation suspension with long- term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.12), Clinical Pharmacology (12.3)].

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