ADVERSE REACTIONS FROM CLINICAL STUDIES

The incidence of adverse reactions (≥1% and more common than placebo) associated with ANORO is based on four 6-month studies: 2 placebo-controlled studies and 2 active‑controlled studies.

ADVERSE EVENTS 

ANORO ELLIPTA

(n=842)

UMEC 62.5 mcg

(n=418)

VI 25 mcg

(n=1034)

PLACEBO

(n=555)

Pharyngitis 2% 1% 2% <1%
Sinusitis 1% <1% 1% <1%
Lower respiratory tract infection 1% <1% <1% <1%
Constipation 1% <1% <1% <1%
Diarrhea 2% <1% 2% 1%
Pain in extremity 2% <1% 2% 1%
Muscle spasms 1% <1% <1% <1%
Neck pain 1% <1% <1% <1%
Chest pain 1% <1% <1% <1%

12-month study: In a long-term safety study, subjects (n=335) were treated for up to 12 months with UMEC/VI 125 mcg/25 mcg or placebo. Adverse reactions that occurred with a frequency of ≥1% in the group receiving UMEC/VI 125 mcg/25 mcg that exceeded that in placebo in this study were:

  • headache
  • back pain
  • sinusitis
  • cough
  • urinary tract infection
  • arthralgia
  • nausea
  • vertigo
  • abdominal pain
  • pleuritic pain
  • viral respiratory tract infection
  • toothache
  • diabetes mellitus
  • headache
  • back pain
  • sinusitis
  • cough
  • urinary tract infection
  • arthralgia
  • nausea
  • vertigo
  • abdominal pain
  • pleuritic pain
  • viral respiratory tract infection
  • toothache
  • diabetes mellitus