Budesonideside effects

Systemic and inhaled corticosteroid use may result in the following: Candida albicans Infection Hypersensitivity Reactions Including Anaphylaxis Immunosuppression Hypercorticism and Adrenal Suppression Reduction in Bone Mineral Density Growth Effects in Pediatric Patients Glaucoma, Increased Intraocular Pressure and Cataracts Eosinophilic Conditions and Churg-Strauss Syndrome Most common adverse reactions (incidence > 3%) are respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, rash To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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 ≥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. 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 Budesonide Inhalation Suspension Vehicle Placebo (n = 227) % Total Daily Dose 0.25 mg (n=178) % 0.5 mg (n = 223) % 1 mg (n = 317) % Adverse Events 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 Disorders 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: 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.

6.2 Postmarketing

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 Eye disorders: cataracts, glaucoma, increased intraocular pressure 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 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 postmarketing reports for budesonide inhalation suspension.