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
