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 (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000). The majority of frequencies were determined from pooled clinical trial data from 23 asthma and 7 COPD studies. Not all events were reported in clinical trials. For these events, the frequency was calculated based on spontaneous data.
Clinical Trial Data: Infections and infestations: Common: Candidiasis of mouth and throat, pneumonia (in COPD patients). Rare: Oesophageal candidiasis.
Immune system disorders: Hypersensitivity Reactions: Uncommon: Cutaneous hypersensitivity reactions, dyspnoea. Rare: Anaphylactic reactions.
Endocrine disorders: Possible systemic effects include (see Precautions): Uncommon: Cataract. Rare: Glaucoma.
Metabolism and nutrition disorders: Uncommon: Hyperglycaemia.
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.
Skin and subcutaneous tissue disorders: Uncommon: Contusions.
Musculoskeletal and connective tissue disorders: Common: Muscle cramps, arthralgia.
Post-marketing Data: Immune system disorders: Hypersensitivity reactions manifesting as: Rare: Angioedema (mainly facial and oropharyngeal oedema) and bronchospasm.
Endocrine disorders: Possible systemic effects include (see Precautions): Rare: Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density.
Respiratory, thoracic and mediastinal disorders: Rare: Paradoxical bronchospasm (see Precautions).
View ADR Monitoring Form