ADVERSE REACTIONS

 
 
 

See the adverse reactions
for BREO

Adverse Reactions

12-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)
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%

*Includes oral candidiasis and oropharyngeal candidiasis

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:

  • Viral respiratory tract infection
  • Pharyngitis
  • Pyrexia
  • Arthralgia

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:

  • Pyrexia
  • Back pain
  • Extrasystoles
  • Upper abdominal pain
  • Respiratory tract infection
  • Allergic rhinitis
  • Pharyngitis
  • Rhinitis
  • Arthralgia
  • Supraventricular extrasystoles
  • Ventricular extrasystoles
  • Acute sinusitis
  • Pneumonia

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:

  • Asthma-related hospitalizations occurred in 1% of patients treated with BREO 100/25 compared with 0.7% in patients treated with FF 100 mcg
  • There were no asthma-related deaths or asthma-related intubations observed in this trial
 

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