Serevent Diskus Side Effects

6 ADVERSE REACTIONS LABA, including salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without ICS) increase the risk of asthma-related death.

Data from a large 28-week placebo-controlled U.S.

trial that compared the safety of salmeterol or placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol.

Available data from controlled clinical trials suggest that LABA as monotherapy increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see Warnings and Precautions ( 5.1 ), Clinical Studies ( 14.1 )] .

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.

Most common adverse reactions (incidence ≥5%) are: • Asthma: Headache, influenza, nasal/sinus congestion, pharyngitis, rhinitis, tracheitis/bronchitis.

( 6.1 ) • COPD: Cough, headache, musculoskeletal pain, throat irritation, viral respiratory infection.

( 6.2 ) 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 in Asthma Adult and Adolescent Subjects Aged 12 Years and Older Two multicenter, 12-week, placebo-controlled clinical trials evaluated twice-daily doses of SEREVENT DISKUS in subjects aged 12 years and older with asthma.

Table 1 reports the incidence of adverse reactions in these 2 trials.

Adverse Reactions with SEREVENT DISKUS with ≥3% Incidence and More Common than Placebo in Adult and Adolescent Subjects with Asthma a a Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of ≥3% in the group receiving SEREVENT DISKUS and were more common than in the placebo group.