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 including rashes, urticaria, pruritus, erythema and angioedema, face, anaphylactoid/anaphylactic reactions, bronchospasm.
Nervous system disorders: Common: Unpleasant taste, unpleasant smell.
Eye disorders: Very rare: Glaucoma, raised intraocular pressure, cataract.
Respiratory, thoracic and mediastinal disorders: Common: Epistaxis, nasal dryness, nasal irritation, throat dryness, throat irritation.
Very rare: Nasal septal perforation.