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warnings
WARNINGS AVOID CONTACT WITH THE EYES. Application of BACTROBAN NASAL to the eye under testing conditions has caused severe symptoms such as burning and tearing. These symptoms resolved within days to weeks after discontinuation of the ointment. In the event of a sensitization or severe local irritation from BACTROBAN NASAL, usage should be discontinued.
ADVERSE REACTIONS 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 Less than 1% of domestic or foreign subjects and patients in clinical trials were withdrawn due to adverse events.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 NASAL ointment, 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 indication.