Advair Diskus

[Salmeterol/Fluticasone]

Side Effects & Drug Interactions
ADVERSE REACTIONS

Asthma:

The incidence of common adverse events in Table 3 is based upon 2 placebo-controlled, 12-week, US clinical studies (Studies 1 and 2). A total of 705 adolescent and adult patients (349 females and 356 males) previously treated with salmeterol or inhaled corticosteroids were treated twice daily with ADVAIR DISKUS (100/50-or 250/50-mcg doses), fluticasone propionate inhalation powder (100-or 250-mcg doses), salmeterol inhalation powder 50 mcg, or placebo.

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Table 3 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in either of the groups receiving ADVAIR DISKUS and were more common than in the placebo group. In considering these data, differences in average duration of exposure should be taken into account.

Rare cases of immediate and delayed hypersensitivity reactions, including rash and other rare events of angioedema and bronchospasm, have been reported. These adverse reactions were mostly mild to moderate in severity. Other adverse events that occurred in the groups receiving ADVAIR DISKUS in these studies with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were:

Blood and Lymphatic

Lymphatic signs and symptoms.

Cardiovascular

Palpitations.

Drug Interaction, Overdose, and Trauma

Muscle injuries, fractures, wounds and lacerations, contusions and hematomas, burns.

Ear, Nose, and Throat

Rhinorrhea/postnasal drip; ear, nose and throat infections; ear signs and symptoms; nasal signs and symptoms; nasal sinus disorders; rhinitis; sneezing; nasal irritation; blood in nasal mucosa.

Eye

Keratitis and conjunctivitis, viral eye infections, eye redness.

Gastrointestinal

Dental discomfort and pain, gastrointestinal signs and symptoms, gastrointestinal infections, gastroenteritis, gastrointestinal disorders, oral ulcerations, oral erythema and rashes, constipation, appendicitis, oral discomfort and pain.

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