Advair Diskus

[Salmeterol/Fluticasone]

Hepatobiliary Tract and Pancreas

Abnormal liver function tests.

Lower Respiratory

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Lower respiratory signs and symptoms, pneumonia, lower respiratory infections.

Musculoskeletal

Arthralgia and articular rheumatism; muscle stiffness, tightness, and rigidity; bone and cartilage disorders.

Neurology

Sleep disorders, tremors, hypnagogic effects, compressed nerve syndromes.

Non-Site Specific

Allergies and allergic reactions, congestion, viral infections, pain, chest symptoms, fluid retention, bacterial infections, wheeze and hives, unusual taste.

Skin

Viral skin infections, urticaria, skin flakiness and acquired ichthyosis, disorders of sweat and sebum, sweating.

The incidence of common adverse events reported in Study 3, a 28-week, non-US clinical study of 503 patients previously treated with inhaled corticosteroids who were treated twice daily with ADVAIR DISKUS 500/50, fluticasone propionate inhalation powder 500 mcg and salmeterol inhalation powder 50 mcg used concurrently, or fluticasone propionate inhalation powder 500 mcg was similar to the incidences reported in Table 3.

Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis:

The incidence of common adverse events in Table 4 is based upon 1 placebo-controlled, 24-week, US clinical trial in patients with COPD associated with chronic bronchitis. A total of 723 adult patients (266 females and 457 males) were treated twice daily with ADVAIR DISKUS 250/50, fluticasone propionate inhalation powder 250 mcg, salmeterol inhalation powder 50 mcg, or placebo.

Table 4 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving ADVAIR DISKUS 250/50 and were more common than in the placebo group. These adverse reactions were mostly mild to moderate in severity. Other adverse events that occurred in the groups receiving ADVAIR DISKUS 250/50 with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were:

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