Incruse Ellipta Adverse Reactions

Summary of the safety profile: The most frequently reported adverse reactions with INCRUSE were nasopharyngitis and upper respiratory tract infection.
Tabulated summary of adverse reactions: The safety profile of umeclidinium bromide was evaluated from 1663 patients with COPD who received doses of 62.5 micrograms or greater for up to one year. This includes 576 patients who received the recommended dose of 62.5 micrograms once daily.
The frequencies assigned to the adverse reactions identified in the table as follows include crude incidence rates observed from four efficacy studies and the long-term safety study (which involved 1,412 patients who received umeclidinium bromide).
The frequency of adverse reactions is defined using 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 <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data). (See Table 2.)

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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.