Adverse events are listed as follows by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports. Very common, common and uncommon events were generally determined from clinical trial data. Rare and very rare events were generally determined from spontaneous data.
Infections and infestations: Very common: Candidiasis of mouth and throat.
Candidiasis of the mouth and throat (thrush) occurs in some patients. Such patients may find it helpful to rinse out their mouth with water after using their medication.
Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with FLIXOTIDE.
Common: Pneumonia (in COPD patients).
Rare: Oesophageal candidiasis.
Immune system disorders: Hypersensitivity reactions with the following manifestations have been reported: Uncommon: Cutaneous hypersensitivity reactions.
Very rare: Angioedema (mainly facial and oropharyngeal oedema), respiratory symptoms (dyspnoea and/or bronchospasm) and anaphylactic reactions.
Endocrine disorders: Possible systemic effects include (see Precautions): Very Rare: Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma.
Metabolism and nutrition disorders: Very rare: Hyperglycaemia.
Psychiatric disorders: Very rare: Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children).
Respiratory, thoracic and mediastinal disorders: Common: Hoarseness.
In some patients inhaled FLIXOTIDE may cause hoarseness. It may be helpful to rinse out the mouth with water immediately after inhalation.
Very rare: Paradoxical bronchospasm (see Precautions).
Skin and subcutaneous tissue disorders: Common: Contusions.