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ADVERSE REACTIONS FROM 6-MONTH 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 Reactions

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

UMEC=umeclidinium; VI=vilanterol.