Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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) and 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) ] Most common adverse reactions (incidence of ≥3%) are respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, rash ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.
at 1-800-399-2561 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.
5 WARNINGS AND PRECAUTIONS Localized Infections: Candida albicans infection of the mouth and throat may occur.
Monitor patients periodically for signs of adverse effects on the oral cavity.
Advise patients to rinse the mouth following inhalation.
( 5.1 ) Deterioration of Disease and Acute Asthma Episodes: Do not use for the relief of acute bronchospasm.
( 5.2 ) Hypersensitivity Reactions: Anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of budesonide inhalation suspension.
Like all medications, Budesonide Inhalation can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: