PULMICORT is generally well tolerated. Most adverse reactions have been mild and of a local character. Systemic effects and oropharyngeal complications caused by budesonide were found to be dose dependent.
Clinical signs of steroid excess were present in 50% of patients (n=10) taking 1.6 mg or more daily of budesonide alone for long periods.
Clinical trials, literature reports and post-marketing experience suggest that the following adverse drug reactions may occur: Common (>1/100, <1/10): Mild irritation in the throat, candida infection in the oropharynx, hoarseness, coughing.
Rare (>1/10,000, <1/1,000): Nervousness, restlessness, depression, behavioural disturbances,
immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema, bronchospasm and anaphylactic reaction, skin bruising.
In rare cases, through unknown mechanisms, drugs for inhalation may cause bronchospasm.
In rare cases signs or symptoms of systemic glucocorticosteroid effect, including hypofunction of the adrenal gland and reduction of growth velocity, may occur with inhaled glucocorticosteroids, probably depending on dose, exposure time, concomitant and previous steroid exposure, and individual sensitivity.
Facial skin irritation has occurred in some cases when a nebuliser with a face mask has been used. To prevent irritation the face should be washed with water after each use of PULMICORT RESPULES delivered via a nebuliser with a face mask.