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) 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 (thrush) 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 inhalation. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the FLIXOTIDE.
Rare: Oesophageal candidiasis.
Immune system disorders: Hypersensitivity reactions with the following manifestations have been reported: Uncommon: Cutaneous hypersensitivity reactions.
Rare: Angioedema (mainly facial and oropharyngeal oedema), respiratory symptoms (dyspnoea and/or bronchospasm).
Very rare: Anaphylactic reactions.
Skin and subcutaneous tissue disorders: Common: Contusions.
Endocrine disorders: Possible systemic effects include (see Precautions): Rare: Adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma.
There have also been reports of Cushing's syndrome and Cushingoid features.
Psychiatric disorders: Very rare: Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children).
Metabolism and nutrition disorders: Very rare: Hyperglycaemia.
Respiratory, thoracic and mediastinal disorders: Common: Hoarseness.
In some patients FLIXOTIDE may cause hoarseness. It may be helpful to rinse out the mouth with water immediately after inhalation.
Rare: Paradoxical bronchospasm (see Precautions).
In two studies in children from ages 1- 4, fluticasone propionate 50 mcg b.d., 100 mcg b.d. and 250 mcg b.d. was as well tolerated as placebo. In these studies, skin rash, allergic skin reactions, throat irritation, nasal irritation, epistaxis, hoarseness/dysphonia, and candidiasis of the mouth/throat were reported at frequencies between 0% and 5%. There were no significant differences in incidence of these occurrences between groups.