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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 Less than 1% of domestic or foreign subjects and patients in clinical trials were withdrawn due to adverse events.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)
(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 (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.