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 Inhalation Aerosol in patients 12 years of age and older with asthma. Table 3 reports the incidence of adverse events in these 2 studies.  Table 3 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in the group treated with SEREVENT Inhalation Aerosol and were more common in the group treated with SEREVENT Inhalation Aerosol than in the placebo group. Pharyngitis, allergic rhinitis, dizziness/giddiness, and influenza occurred at 3% or more but were equally common on placebo. Other events occurring in the group treated with SEREVENT Inhalation Aerosol at a frequency of 1% to 3% were as follows: Cardiovascular Tachycardia, palpitations. Ear, Nose, and Throat Rhinitis, laryngitis. Gastrointestinal Nausea, viral gastroenteritis, nausea and vomiting, diarrhea, abdominal pain. Hypersensitivity Urticaria. Mouth and Teeth: Dental pain. Musculoskeletal Pain in joint, back pain, muscle cramp/contraction, myalgia/myositis, muscular soreness. Neurological Nervousness, malaise/fatigue. Respiratory Tracheitis/bronchitis. Skin Rash/skin eruption. Urogenital Dysmenorrhea. Data from small dose-response studies show an apparent dose relationship for tremor, nervousness, and palpitations. In clinical trials evaluating concurrent therapy of salmeterol with inhaled corticosteroids, adverse events were consistent with those previously reported for salmeterol, or might otherwise be expected with the use of inhaled corticosteroids. | ||||
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