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AstraZeneca Comments on FDA Joint Advisory Committee Meeting on Post-Marketing Safety Studies for the Use of LABAs in Asthma
Date:3/11/2010

The most common adverse events greater than or equal to 5% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.

Additional Information Specific to COPD

For patients with COPD, the approved dosage of SYMBICORT is 160/4.5 mcg, 2 inhalations twice daily.

The most common adverse events greater than or equal to 3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection.

Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids.

In 2 placebo-controlled SYMBICORT COPD clinical studies, pneumonia did not occur with greater incidence in the SYMBICORT 160/
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