Clinical Trials: In clinical trials, 210 domestic and 2,130 foreign adult subjects/patients received BACTROBAN NASAL (mupirocin calcium ointment) 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 Less than 1% of domestic or foreign subjects and patients in clinical trials were withdrawn due to adverse events.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 (mupirocin calcium ointment)
|Respiratory disorder, including upper respiratory tract congestion||5%|
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 (mupirocin calcium ointment) 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.