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), bronchitis.
Rare: Oesophageal candidiasis.
Immune system disorders: Hypersensitivity Reactions: Uncommon: Cutaneous hypersensitivity reactions, dyspnoea.
Rare: Anaphylactic reactions, bronchospasm, angioedema (mainly facial and oropharyngeal oedema).
Endocrine disorders: Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density.
Metabolism and nutrition disorders: Common: Hypokalaemia.
Uncommon: Hyperglycaemia.
Psychiatric disorders: Uncommon: Anxiety, sleep disorders.
Rare: Behavioural changes, including hyperactivity and irritability (predominantly in children).
Not known: Depression, aggression (predominantly in children).
Nervous system disorders: Very common: Headache (see Precautions).
Uncommon: Tremor (see Precautions).
Eye disorders: Uncommon: Cataract.
Rare: Glaucoma.
Cardiac disorders: Uncommon: Palpitations (see Precautions), tachycardia, atrial fibrillation, angina pectoris.
Rare: Cardiac arrhythmias including supraventricular tachycardia and extrasystoles.
Respiratory, thoracic and mediastinal disorders: Very common: Nasopharyngitis.
Common: Hoarseness/dysphonia, throat irritation, sinusitis.
Rare: Paradoxical bronchospasm.
Skin and subcutaneous tissue disorders: Uncommon: Contusions.
Musculoskeletal and connective tissue disorders: Common: Muscle cramps, arthralgia, traumatic fractures, myalgia.
Postmarketing Data: Cardiovascular: Arrhythmias (including atrial fibrillation, extrasystoles, supraventricular tachycardia), hypertension, ventricular tachycardia.
Ear, Nose, and Throat: Aphonia, earache, facial and oropharyngeal edema, paranasal sinus pain, rhinitis, throat soreness, tonsillitis.
Endocrine and Metabolic: Cushing's syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism, osteoporosis.
Eye: Cataracts, glaucoma.
Gastrointestinal: Dyspepsia, xerostomia.
Hepatobiliary Tract and Pancreas: Abnormal liver function tests.
Immune System: Immediate and delayed hypersensitivity reactions, including rash and rare events of angioedema, bronchospasm.
Infections and Infestations: Esophageal candidiasis.
Musculoskeletal: Back pain, myositis.
Neurology: Paresthesia, restlessness.
Non-Site Specific: Fever, pallor.
Psychiatry: Agitation, aggression, depression. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.
Respiratory: Asthma; asthma exacerbation; chest congestion; cough; dyspnea; immediate bronchospasm; influenza; paradoxical bronchospasm; tracheitis; wheezing; pneumonia; reports of upper respiratory symptoms of laryngeal spasm, irritation, or stridor or choking.
Skin: Contact dermatitis, contusions, ecchymoses, photodermatitis, pruritus.
Urogenital: Dysmenorrhea, irregular menstrual cycle, pelvic inflammatory disease, vaginal candidiasis, vaginitis, vulvovaginitis.
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