Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Serious asthma-related events–hospitalizations, intubations, death [see Warnings and Precautions ( 5.1 )] • Paradoxical bronchospasm [see Warnings and Precautions ( 5.5 )] • Cardiovascular effects [see Warnings and Precautions ( 5.7 )] • Worsening of narrow-angle glaucoma [see Warnings and Precautions ( 5.9 )] • Worsening of urinary retention [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (incidence ≥1% and more common than placebo) are pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremity, muscle spasms, neck pain, and chest pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical program for ANORO ELLIPTA included 8,138 subjects with COPD in four 6‑month lung function trials, one 12-month long-term safety study, and 9 other trials of shorter duration.
A total of 1,124 subjects have received at least 1 dose of ANORO ELLIPTA (umeclidinium/vilanterol 62.5/25 mcg), and 1,330 subjects have received a higher dose of umeclidinium/vilanterol (125/25 mcg).
The safety data described below are based on the four 6-month and one 12-month trials.
Adverse reactions observed in the other trials were similar to those observed in the confirmatory trials.
6-Month Trials The incidence of adverse reactions associated with ANORO ELLIPTA in Table 1 is based on four 6-month trials: 2 placebo-controlled trials (Trial 1 and Trial 2);
N = 1,532 and N = 1,489, respectively) and 2 active-controlled trials (Trial 3 and Trial 4);
N = 843 and N = 869, respectively).
5 WARNINGS AND PRECAUTIONS • LABA monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events.
( 5.1 ) • Do not initiate in acutely deteriorating COPD.
Do not use to treat acute symptoms.
( 5.2 ) • Do not use in combination with additional therapy containing a LABA because of risk of overdose.
( 5.3 ) • If paradoxical bronchospasm occurs, discontinue ANORO ELLIPTA and institute alternative therapy.
Like all medications, Anoro Ellipta can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: