Adverse events are listed as follows by system organ class and frequency. Frequencies are defined as: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1,000 to <1/100; Rare ≥1/10,000 to <1/1,000; Very rare <1/10,000.
Infections and infestations: Common: Candidiasis of mouth and throat, pneumonia (in COPD patients).
Rare: Oesophageal candidiasis.
Immune system disorders: Hypersensitivity reactions manifesting as: Uncommon: Cutaneous hypersensitivity reactions, dyspnoea.
Rare: Angioedema (mainly facial and oropharyngeal oedema), bronchospasm and anaphylactic reactions.
Endocrine disorders: Possible systemic effects include (see Precautions): Uncommon: Cataract.
Rare: Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density and glaucoma.
Metabolism and nutrition disorders: Uncommon: Hyperglycemia.
Psychiatric disorders: Uncommon: Anxiety, sleep disorders.
Rare: Behavioural changes, including hyperactivity and irritability (predominantly in children).
Nervous system disorders: Very common: Headache (see Precautions).
Uncommon: Tremor (see Precautions).
Cardiac disorders: Uncommon: Palpitations (see Precautions), tachycardia, atrial fibrillation.
Rare: Cardiac arrhythmias including supraventricular tachycardia and extrasystoles.
Respiratory, thoracic and mediastinal disorders: Common: Hoarseness/dysphonia.
Uncommon: Throat irritation.
Rare: Paradoxical bronchospasm (see Precautions).
Skin and subcutaneous tissue disorders: Uncommon: Contusions.
Musculoskeletal and connective tissue disorders: Common: Muscle cramps, arthralgia.
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