Momate Nasal Spray Adverse Reactions

Epistaxis was generally self-limiting and mild in severity and occurred at a higher incidence comparable to placebo (5%), but at a comparable or lower incidence when compared to the active control nasal corticosteroids studied (up to 15%). The incidence of all other effects was comparable with that of placebo.
In the paediatric population the incidence of adverse events e.g. epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.
In patients treated for nasal polyposis, the overall incidence of adverse events was comparable to placebo and similar so that observed for patients with allergic rhinitis. Treatment-related adverse events reported in 1% of patients in clinical studies for polyposis are shown as follows. (See Table 2.)

Click on icon to see table/diagram/image

In patients treated for acute rhinosinusitis, the incidence of epistaxis for Mometasone was 3.3% vs 2.6% for placebo and similar to that observed for patients treated with allergic rhinitis.
Rarely immediate hypersensitivity reactions, including bronchospasm and dyspnoea, may occur after intranasal administration of mometasone furoate monohydrate. Very rarely, anaphylaxis and angioedema have been reported.
Systemic effects of nasal corticosteroids may occur particularly when prescribed at high doses for prolonged periods.
Acute Rhinosinusitis: In patients treated for acute rhinosinusitis, the overall incidence of adverse events was compared to placebo and similar to that observed for patients with allergic rhinitis.
Adjunctive treatment of acute episodes of sinusitis: In adult and adolescent patients receiving Mometasone furoate Aqueous Nasal Spray as adjunctive treatment for acute episodes of sinusitis, treatment-related adverse events, which occurred at an incidence comparable to placebo, included headache (2%), pharyngitis (1%), nasal burning (1%) and nasal irritation (1%). Epistaxis was mild in severity and also occurred at an incidence comparable to placebo (5% vs. 4%, respectively).
Post-Marketing Experience: The following adverse reactions have been identified during the post-marketing period for Mometasone furoate monohydrate Nasal Spray 50 mcg: nasal burning and irritation, anaphylaxis and angioedema, disturbances in taste and smell and nasal septal perforation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.