Clinical Trials Experience: Treatment-related local adverse events reported in clinical studies include headache (8%), epistaxis (i.e., frank bleeding, blood-tinged mucus, and blood flecks) (8%), pharyngitis (4%), nasal burning (2%), nasal irritation (2%), and nasal ulceration, which are typically observed with use of a corticosteroid nasal spray. Epistaxis was generally self-limiting and mild in severity, and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence compared to active control nasal corticosteroids studied (up to 15%). The incidence of all other effects was comparable with that of placebo.
In the pediatric population, the incidence of adverse effects, e.g., headache (3%), epistaxis (6%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.
Post-Marketing Experience: Rarely, immediate hypersensitivity reactions (e.g. bronchospasm, dyspnea) may occur after intranasal administration of mometasone furoate. Very rarely, anaphylaxis, angioedema, chest pain, palpitation and tachycardia have been reported.
Disturbances of taste and smell have been reported very rarely.
Nasal Polyposis: In patients treated for nasal polyposis, the overall incidence of adverse events was comparable to placebo and similar to that observed for patients with allergic rhinitis.
Acute rhinosinusitis: In patients treated for acute rhinosinusitis, the overall incidence of adverse events was comparable to placebo and similar to that observed for patients with allergic rhinitis.
Treatment related adverse events reported most frequently in 200 μg twice daily group include epistaxis (3.7% vs. placebo 2.6%), diarrhoea (2.1% vs. placebo 0.8%), headache (1.7% vs. placebo 2.4%), nausea (1.7% vs. placebo 0.6%) and abdominal pain (1.7% vs. placebo 1.0%).