Bactroban Ointment

[Mupirocin]

Side Effects & Drug Interactions
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 Less than 1% of domestic or foreign subjects and patients in clinical trials were withdrawn due to adverse events.

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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:

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,
rash.

All adequate and well-controlled clinical trials have been performed using Bactroban Nasal ointment, 2% in one 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.

Drug Interactions

The effect of the concurrent application of intranasal mupirocin calcium and other intranasal products has not been studied. Until further information is known, mupirocin calcium ointment, 2% should not be applied concurrently with any other intranasal products.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential of mupirocin calcium have not been conducted.

Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for mutagenicity: rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.

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