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 1.6mg 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 (more than 1%): Nose and throat: hoarseness; sore, irritated throat; irritation of the tongue and mouth; dry mouth; oral candidiasis.
Infections and infestations: pneumonia (in COPD patients).
Uncommon (less than 1%): Nose and throat: irritation of the larynx; bad taste.
Gastrointestinal: diarrhoea; nausea.
Hypersensitivity reactions: Immediate and delayed hypersensitivity reactions such as skin reactions (eg. urticaria, rash, dermatitis), bronchospasm, angioedema and anaphylactic reaction.
Central Nervous System: headache; lightheadedness; thirst; tiredness.
Metabolic and nutritional disorders: weight gain.
Eye disorders: Vision blurred.
If oropharyngeal candidiasis develops, it may be treated with appropriate anti-fungal therapy whilst still continuing with PULMICORT therapy. The incidence of candidiasis can generally be held to a minimum by having patients rinse their mouth with water after each inhalation.
Inhaled steroids may have adverse effects in higher than recommended doses; possible systemic effects of inhaled steroids include depression of the HPA axis, reduction of bone density and retardation of growth rate in children (see PRECAUTIONS - Potential systemic effects of inhaled corticosteroids).
Reduction in growth velocity has been reported in association with administration of inhaled corticosteroids, however studies with budesonide indicate that this is transient and that final adult height may ultimately be achieved (see PRECAUTIONS - Growth).
Dose dependent HPA axis suppression has been observed with budesonide, however this may represent a physiological adaption rather than adrenal insufficiency (see PRECAUTIONS - HPA axis suppression and adrenal insufficiency). The lowest dose that results in clinically relevant adrenal insufficiency has not been established.
No negative effects on bone mass have been observed in adults treated with inhaled budesonide at recommended doses. In children, bone mineral density should be interpreted with caution as an increase in bone area may reflect an increase in bone volume (see PRECAUTIONS - Bone density).
Rare reports of skin bruising have occurred following treatment with inhaled glucocorticosteroids.
Psychiatric symptoms such as behavioural disturbances, nervousness, restlessness and depression have been observed with budesonide as well as other glucocorticosteroids.
Facial skin irritation has occurred in a few cases when a nebuliser with a face mask has been used. To prevent irritation the face should be washed after each use of PULMICORT RESPULES delivered via a nebuliser with a face mask.
Rarely, PULMICORT may provoke bronchoconstriction in hyperreactive patients. Bronchospasm may be treated with an inhaled β2- agonist.