Mometasone Sandoz Adverse Reactions

Summary of the safety profile: 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 when compared to the active control nasal corticosteroids studied (up to 15%) as reported in clinical studies for allergic rhinitis. The incidence of all other adverse events was comparable with that of placebo.
In patients treated for nasal polyposis, the overall incidence of adverse events was similar to that observed for patients with allergic rhinitis.
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.
List of adverse reactions: Treatment related adverse reactions (≥1%) reported in clinical trials in patients with allergic rhinitis or nasal polyposis and post-marketing regardless of indication are presented. Adverse reactions are listed according to MedDRA primary system organ class. Within each system organ class, adverse reactions are ranked by frequency. Frequencies were defined as follows: Very common (>=1/10), common (>=1/100 to <1/10), uncommon (>=1/1,000 to <1/100). The frequency of post-marketing adverse events are considered as "not known (cannot be estimated from the available data)".
Treatment-related adverse reactions reported by system organ class and frequency: Infections and infestations: Common: Pharyngitis, upper respiratory tract infection^†
Immune system disorders: Not known: Hypersensitivity including anaphylactic reactions, angioedema, bronchospasm and dyspnoea.
Nervous system disorders: Common: Headache.
Eye disorders: Not known: Glaucoma, increased intraocular pressure, cataracts, vision blurred (see Precautions), central serous chorioretinopathy.
Respiratory, thoracic and mediastinal disorders: Very common: Epistaxis*.
Common: Epistaxis, nasal burning, nasal irritation, nasal ulceration.
Not known: Nasal septum perforation.
Gastrointestinal disorders: Common: Throat irritation*.
Not known: Disturbances of taste and smell.
*recorded for twice daily dosing for nasal polyposis.
†recorded at uncommon frequency for twice daily dosing for nasal polyposis.
Paediatric population: In the paediatric population, the incidence of recorded adverse events in clinical studies, e.g., epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.