Fasenra Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions during treatment are headache (8%) and pharyngitis (3%). Anaphylactic reactions have been reported.
Tabulated list of adverse reactions: A total of 2,514 patients, out of whom 1,663 patients had severe uncontrolled eosinophilic asthma, received benralizumab during clinical studies of 48 to 56 weeks duration.
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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 7.)

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Description of selected adverse reaction: Injection site reactions: In placebo-controlled studies, injection site reactions (e.g. pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with the recommended benralizumab dose compared with 1.9% in patients treated with placebo.
Long-term safety: In a 56-week extension trial in patients with asthma from Trials 1, 2 and 3, 842 patients were treated with Fasenra at the recommended dose and remained in the trial. The overall adverse event profile was similar to the asthma trials described previously.
Paediatric population: There are limited data in paediatric patients (see Pharmacology: Pharmacodynamics under Actions). The frequency, type and severity of adverse reactions in the adolescent population were observed to be similar to those seen in adults.
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 recommended to report any suspected adverse reactions to AstraZeneca.