Budesma Adverse Reactions

General: In general, inhaled corticosteroid therapy may be associated with dose dependent increases in the incidence of ocular complications, reduced bone density, suppression of HPA axis responsiveness to stress, and inhibition of growth velocity in children.
Inhaled corticosteroid treatment for asthma or rhinitis may exacerbate glaucoma. In patients with established glaucoma, who require long-term inhaled corticosteroid treatment, it is advisable to measure intraocular pressure before commencing the inhaled corticosteroid and to monitor it subsequently. In patients without established glaucoma, but with a potential for developing intraocular hypertension (e.g., the elderly), intraocular pressure should be monitored at appropriate intervals.
The prevalence of posterior sub-capsular and nuclear cataracts is probably low in elderly patients treated with inhaled corticosteroids, but increased in relation to the daily and cumulative lifetime dose. Co-factors such as smoking, ultraviolet B exposure, or diabetes may increase the risk. Children may be less susceptible.
A reduction in growth velocity in children or teenagers may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment. Physicians should closely follow the growth of adolescents taking corticosteroids by any route and weigh the benefits of corticosteroid therapy and asthma control against the possibility of growth suppression if any adolescent's growth appears slowed.
Osteoporosis and fractures are the major complications of long-term asthma treatment with parenteral or oral steroids. Inhaled corticosteroid therapy is also associated with dose dependent bone loss although the degree of risk is very much lesser than with oral steroid. This risk may be offset by estrogen replacement in postmenopausal women, and by titrating the daily dose of inhaled steroid to the minimum required to maintain optimal asthma control. It is not known yet whether the peak bone density achieved during youth is adversely affected, if substantial amounts of inhaled corticosteroid are administered prior to 30 years of age. Failure to achieve maximal bone density during youth could increase the risk of osteoporotic fracture when these individuals reach 60 years of age and older.
Paradoxical Bronchospasm: Similar to other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, immediately discontinue the therapy and institute alternate treatment.
Adrenal Suppression: In the majority of patients, no significant adrenal suppression occurs until one exceeds doses of 1,500 μg/day by inhalation. Reduction of plasma cortisol levels has been reported in some patients who received 2,000 μg/day of inhaled Budesonide.
Gastrointestinal Tract: Therapeutic dosages may lead to growth of C. albicans in the mouth and throat. Long-term studies have shown a dosage-dependent effect. Positive cultures for oral Candida may be present in up to 75% of patients, although the frequency of clinically apparent infection is considerably lower, varying between 0 and 43% with an average of 15%. In children, the incidence of oropharyngeal candidiasis is lower than in adults. In some studies, an overgrowth of A. niger has been found in conjunction with C. albicans. Such affected patients may find it helpful to rinse their mouths with water after using Budesonide.
A few patients on Budesonide have complained of hoarseness, dry mouth or throat irritation. It may be helpful to rinse out the mouth with water immediately after inhalation.
Immunologic Reactions: The replacement of systemic steroids with Budesonide may unmask symptoms of allergies which were previously suppressed by the systemic drug. Conditions such as allergic rhinitis and eczema may thus become apparent during Budesonide therapy after the withdrawal of systemic corticosteroids.
Rare cases of immediate and delayed hypersensitivity reactions, including urticaria, angioedema, rash and bronchospasm, have been reported after the use of Budesonide oral or intranasal inhalers; pruritus, erythema, and edema of the eyes, face, lips and throat also have been reported.
Other Effects: Reports of headache, light-headedness, dryness and irritation of the nose and throat, and unpleasant taste and smell have been received. Rarely there may be a loss of taste and smell sensations.