Ryaltris Adverse Reactions

Adverse Reaction Overview: The most common adverse reactions observed in clinical trials with OLOPATADINE AND MOMETASONE (RYALTRIS) were dysgeusia, headache, epistaxis, and nasal discomfort. No new clinically significant findings were observed as compared with either olopatadine hydrochloride or mometasone furoate alone. The safety profile of OLOPATADINE AND MOMETASONE (RYALTRIS) is typical of that observed with intranasal drugs of the same classes.
Tabulated list of adverse reactions: The following adverse reactions have been reported during clinical studies and post-marketing data and are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) or not known (cannot be estimated from the available data). (See Table 1.)

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Systemic effects of some nasal corticosteroids may occur, particularly when administered at high doses for prolonged periods.
Growth retardation has been reported in children receiving nasal corticosteroids. Growth retardation may be possible in adolescents, too.
Paediatric population: In the paediatric population (children 6 to 11 years of age), at doses half of those in adult populations, the incidence of recorded adverse events in a clinical study in seasonal allergic rhinitis, e.g., dysgeusia (1.3%), headache (1.3%), epistaxis (0.9%) and nasal discomfort (0.9%) was comparable to placebo.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.