Clinical Trials: In clinical trials, 210 domestic and 2,130 foreign adult subjects/patients received BACTROBAN NASAL ointment. Less than 1% of domestic or foreign subjects and patients in clinical trials were withdrawn due to adverse events. The most frequently reported adverse events in foreign clinical trials were as follows: rhinitis (1.0%), taste perversion (0.8%), pharyngitis (0.5%). In domestic clinical trials, 17% (36/210) of adults treated with BACTROBAN NASAL ointment reported adverse events thought to be at least possibly drug-related. The incidence of adverse events that were reported in at least 1% of adults enrolled in domestic clinical trials were as follows: ADVERSE EVENTS ( ≥ 1% INCIDENCE)-ADULTS IN US TRIALS % of Subjects/Patients Experiencing Event BACTROBAN NASAL (n=210) Headache 9% Rhinitis 6% Respiratory disorder, including upper respiratory tract congestion 5% Pharyngitis 4% Taste perversion 3% Burning/stinging 2% Cough 2% Pruritus 1% The following events thought possibly drug-related were reported in less than 1% of adults enrolled in domestic clinical trials: Blepharitis , diarrhea , dry mouth, ear pain, epistaxis , nausea , and rash . All adequate and well-controlled clinical trials have been performed using BACTROBAN NASALointment, 2% in 1 arm and the vehicle ointment in the other arm of the study. No adequate and well-controlled safety data are available from direct, head-to-head comparative studies of this product and other products for this indi
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