Bactroban Cream (mupirocin) Side Effects, Warnings, and Interactions

Bactroban cream (mupirocin) is an antibiotic used topically (on the skin) to treat impetigo and infections of the skin caused by Staphylococcus aureus, beta-hemolytic streptococcus, or Streptococcus pyogenes.

The nasal ointment is used for the elimination of multi-drug resistant nasal Staphylococcus aureus infection in people who are colonized by Staphylococcus aureus. Mupirocin also may be used for other secondary infections.

Common side effects of mupirocin include application site reactions (burning, stinging, pain, and itching).

Other side effects caused by the intranasal use of mupirocin include headache, runny nose, congestion, sore throat, dry skin, swelling (edema), changes in taste, nasal irritation, and cough.

There are no known drug interactions with mupirocin; however, it should not be used at the same time with other drugs that are applied inside the nose.

There are no adequate studies of mupirocin in pregnant women. Studies in animals suggest no important effects on the fetus. Mupirocin may be used in pregnancy if the physician feels it is necessary. There is no information on the safety of mupirocin in nursing infants. It is unknown if any of the small amount of mupirocin that is absorbed from the skin into the blood of the mother concentrates in breast milk. It is advisable not to nurse while using mupirocin.

Side effects are uncommon and mild with mupirocin. The most frequent side effects are:

• Burning
• Stinging
• Pain
• Itching at the area of application

Other side effects caused by the intranasal use of mupirocin include:

• Headache
• Runny nose
• Congestion
• Sore throat
• Dry skin
• Swelling (edema)
• Changes in taste perception
• Nasal irritation
• Cough

The following adverse reactions are discussed in more detail in other sections of the labeling:

• Severe Allergic Reactions
• Eye Irritation
• Local Irritation
• Clostridium difficile-Associated Diarrhea

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 2 randomized, double-blind, double-dummy trials, 339 subjects were treated with topical Bactroban cream plus oral placebo. Adverse reactions occurred in 28 (8.3%) subjects. The following adverse reactions were reported by at least 1% of subjects in connection with the use of Bactroban cream in clinical trials: headache (1.7%), rash (1.1%), and nausea (1.1%).

Other adverse reactions which occurred in less than 1% of subjects were: abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis.

In a supportive trial in the treatment of secondarily infected eczema, 82 subjects were treated with Bactroban cream. The incidence of adverse reactions was as follows: nausea (4.9%), headache and burning at application site (3.6% each), pruritus (2.4%), and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin, and rash.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of Bactroban cream. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to Bactroban cream.

Immune System Disorders

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash.

No information provided.