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. In assigning adverse event frequencies, the background rates in placebo groups were not taken into account, since these rates were generally comparable to those in the active treatment group.
Immune system disorders:
Very rare: Hypersensitivity reactions, anaphylaxis/anaphylactic reactions, bronchospasm, skin rash, oedema of the face or tongue.
Nervous system disorders:
Common: Headache, unpleasant taste, unpleasant smell.
As with other nasal sprays, unpleasant taste and smell and headache have been reported.
Very rare: Glaucoma, raised intraocular pressure, cataract.
A very small number of spontaneous reports have been identified following prolonged treatment. However, clinical trials of up to one year duration have shown that intranasal fluticasone propionate is not associated with an increased incidence of ocular events including cataract, increased intraocular pressure or glaucoma.
Respiratory, thoracic and mediastinal disorders:
Very common: Epistaxis.
Common: Nasal dryness, nasal irritation, throat dryness, throat irritation.
As with other intranasal products, dryness and irritation of the nose and throat, and epistaxis have been reported.
Very rare: Nasal septal perforation. Nasal septal perforation has been reported following the use of intranasal corticosteroids.