Systemic and inhaled corticosteroid use may result in the following:
- Candida albicans infection [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Including Anaphylaxis [see WARNINGS AND PRECAUTIONS]
- Immunosuppression [see WARNINGS AND PRECAUTIONS]
- Hypercorticism and Adrenal Suppression [see WARNINGS AND PRECAUTIONS]
- Reduction in Bone Mineral Density [see WARNINGS AND PRECAUTIONS]
- Growth Effects [see WARNINGS AND PRECAUTIONS and Use in Specific Populations]
- Glaucoma and Cataracts [see WARNINGS AND PRECAUTIONS]
- Eosinophilic conditions and Churg-Strauss [see WARNINGS AND PRECAUTIONS]
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.
PULMICORT FLEXHALER (budesonide inhalation powder)
Patients 6 years and older
The incidence of common adverse reactions in Table 1 is based upon pooled data reported in patients treated with PULMICORT FLEXHALER (budesonide inhalation powder) 180 or 90 mcg in two double blind, placebo-controlled clinical trials in which 226 patients (106 females and 120 males) with mild to moderate asthma, previously receiving bronchodilators, inhaled corticosteroids, or both, were treated with PULMICORT FLEXHALER (budesonide inhalation powder) , administered as 360 mcg twice daily for 12 weeks. In these trials, the patients on PULMICORT FLEXHALER had a mean age of 28 years (range 6-80 years) and were predominantly Caucasian (59.7%) and Asian (31.4%). Table 1 includes all adverse reactions (regardless of investigator causality assessment) that occurred at a rate of ≥ 1% in the PULMICORT FLEXHALER (budesonide inhalation powder) group and more commonly than the placebo group.
Table 1 : Adverse Reactions occurring at an incidence of ≥ 1% and more commonly than placebo in the PULMICORT FLEXHALER (budesonide inhalation powder) group: pooled data from two 12-week, double-blind, placebo-controlled clinical asthma trials in patients 6 years and older
|Adverse Event||PULMICORT FLEXHALER (budesonide inhalation powder) 360 mcg
|Viral upper respiratory tract infection||2.2||1.3|
|Average exposure duration (days)||76.2||68.2|
Long-Term Safety in Patients 6 years of age and older
Non-placebo controlled long-term studies in children (at doses up to 360 mcg daily), and adolescent and adult subjects (at doses up to 720 mcg daily), treated for up to one year with PULMICORT FLEXHALER (budesonide inhalation powder) , revealed a similar pattern and incidence of adverse events.
PULMICORT TURBUHALER; a different PULMICORT DPI
The following adverse reactions occurred in placebo-controlled clinical trials with similar or lower doses with inhaled budesonide via a different PULMICORT dry powder inhaler with an incidence of ≥ 1% in the budesonide group and were more common than in the placebo group:
≥ 3%: respiratory infection, sinusitis, headache, pain, back pain, fever.
≥ 1-3%: neck pain, syncope, abdominal pain, dry mouth, vomiting, weight gain, fracture, myalgia, hypertonia, migraine, ecchymosis, insomnia, infection, taste perversion, voice alteration.
Higher doses of inhaled budesonide (800 mcg twice daily) via a different PULMICORT dry powder inhaler resulted in an increased incidence of voice alteration, flu syndrome, dyspepsia, gastroenteritis, nausea, and back pain, compared with doses of 400 mcg twice daily.
In a 20-week trial in adult asthmatics who previously required oral corticosteroids, the incidence of adverse reactions was evaluated with 400 mcg twice daily (N=53) and 800 mcg twice daily (N=53) of inhaled budesonide via a different PULMICORT dry powder inhaler and compared with placebo (N=53). In considering these data, the increased average duration of exposure for inhaled budesonide patients (78 days for inhaled budesonide vs. 41 days for placebo) should be taken into account. Adverse reactions, regardless of investigator causality assessment, reported in more than five patients in the budesonide group and which occurred more commonly than the placebo group in decreasing order of frequency include: respiratory infection, sinusitis, headache, oral candidiasis, pain, asthenia, dyspepsia, arthralgia, cough increased, nausea and rhinitis.
The following adverse reactions have been reported during post-approval use of PULMICORT FLEXHALER (budesonide inhalation powder) . 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.
Immune system disorders: immediate and delayed hypersensitivity reactions including anaphylactic reaction, angioedema, bronchospasm, rash, contact dermatitis, urticaria, and cough, wheezing or bronchospasm in patients with severe milk protein hypersensitivity [see WARNINGS AND PRECAUTIONS and CONTRAINDICATIONS]
Endocrine disorders: symptoms of hypocorticism and hypercorticism [see WARNINGS AND PRECAUTIONS]
Eye disorders: cataracts, glaucoma, increased intraocular pressure [see WARNINGS AND PRECAUTIONS]
Psychiatric disorders: psychiatric symptoms including psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, and anxiety
Respiratory, thoracic, and mediastinal disorders: throat irritation
Skin and subcutaneous tissue disorders: skin bruising