Effects of treatment with Symbicort 160/, Symbicort 80/, formoterol mcg, or placebo on development of cataracts or glaucoma were evaluated in a subset of 461 patients with COPD in the 12-month lung function study. Ophthalmic examinations were conducted at baseline, 24 weeks, and 52 weeks. There were 26 subjects (6%) with an increase in posterior subcapsular score from baseline to maximum value (>) during the randomized treatment period. Changes in posterior subcapsular scores of > from baseline to treatment maximum occurred in 11 patients (%) in the Symbicort 160/ group, 4 patients (%) in the Symbicort 80/ group, 5 patients (%) in the formoterol group, and 6 patients (%) in the placebo group.
The most commonly reported side effects were: oral thrush , nausea , headache , and pain in the pharynx or larynx . More rarely reported side effects (occurring in <1% of patients during the clinical trial) include: tachycardia , palpitations , dry mouth , allergic reaction ( bronchospasm , dermatitis , hives ), pharyngitis , muscle spasms , tremor , dizziness , insomnia , nervousness , and hypertension . Patients experiencing an allergic reaction or increase in difficulty breathing while using this medication should immediately discontinue its use and contact their physician.