ADVERSE REACTIONS
Learn more about the adverse reactions in asthma.
SEE PRESCRIBING INFO12-week study: Adverse reactions with ≥2% incidence in any treatment group
ADVERSE REACTION | BREO 100/25 (n=346) | BREO 200/25 (n=346) | FLUTICASONE FUROATE 100 mcg (n=347) |
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Headache | 8% | 8% | 9% |
Nasopharyngitis | 6% | 7% | 7% |
Influenza | 3% | 3% | 1% |
Upper Respiratory Tract Infection | 2% | 2% | 3% |
Sinusitis | 1% | 2% | <1% |
Bronchitis | <1% | 2% | 2% |
Oropharyngeal Pain | 2% | 2% | 1% |
Cough | 2% | 1% | 1% |
Placebo-controlled 12-week study: Adverse reactions with ≥2% incidence in any treatment group and more common than in placebo
ADVERSE REACTION | BREO 100/25 (n=201) | FLUTICASONE FUROATE 100 mcg (n=205) | PLACEBO (n=203) |
---|---|---|---|
Nasopharyngitis | 10% | 7% | 7% |
Oral Candidiasis* | 2% | 2% | 0% |
Headache | 5% | 4% | 4% |
Oropharyngeal Pain | 2% | 2% | 1% |
Dysphonia | 2% | 1% | 0% |
24-week study: In addition to those listed in the tables above, adverse reactions occurring in ≥2% of patients treated with BREO 200/25 included:
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52-week study: In addition to those listed in the tables above, adverse reactions occurring in ≥2% of patients treated with BREO 100/25 or BREO 200/25 for 12 months included:
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24- to 76-week study: In a 24- to 76-week study of patients with a history of ≥1 asthma exacerbations within the previous 12 months:
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