Serevent Diskus

[Salmeterol]

Side Effects & Drug Interactions
ADVERSE REACTIONS

Adverse reactions to salmeterol are similar in nature to reactions to other selective beta2-adrenoceptor agonists, i.e., tachycardia; palpitations; immediate hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm (see WARNINGS); headache; tremor; nervousness; and paradoxical bronchospasm (see WARNINGS). Asthma: Two multicenter, 12-week, controlled studies have evaluated twice-daily doses of SEREVENT DISKUS in patients 12 years of age and older with asthma. Table 3 reports the incidence of adverse events in these 2 studies.

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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 the group receiving SEREVENT DISKUS and were more common than in the placebo group. Pharyngitis, sinusitis, upper respiratory tract infection, and cough occurred at 3% but were more common in the placebo group. However, throat irritation has been described at rates exceeding that of placebo in other controlled clinical trials. Other adverse events that occurred in the group receiving SEREVENT DISKUS in these studies with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were:

Ear, Nose, and Throat:

Sinus headache.

Gastrointestinal:

Nausea.

Mouth and Teeth:

Oral mucosal abnormality.

Musculoskeletal:

Pain in joint.

Neurological:

Sleep disturbance, paresthesia.

Skin: Contact dermatitis, eczema.

Miscellaneous:

Localized aches and pains, pyrexia of unknown origin.

Two multicenter, 12-week, controlled studies have evaluated twice-daily doses of SEREVENT DISKUS in patients aged 4 to 11 years with asthma. 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 SEREVENT DISKUS and were more common than in the placebo group.

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