Atectura Breezhaler Adverse Reactions

Summary of the safety profile: The most common adverse reactions over 52 weeks were asthma (exacerbation) (26.9%), nasopharyngitis (12.9%), upper respiratory tract infection (5.9%) and headache (5.8%).
Tabulated list of adverse reactions: Adverse drug reactions (ADRs) are listed by MedDRA system organ class (Table 3). The frequency of the ADRs is based on the PALLADIUM study. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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). (See Table 3.)

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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.