May 25, 2016
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Bactroban Cream

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Bactroban Cream




Side Effects
Interactions

SIDE EFFECTS

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

  • Severe Allergic Reactions [see WARNINGS AND PRECAUTIONS]
  • Eye Irritation [see WARNINGS AND PRECAUTIONS]
  • Local Irritation [see WARNINGS AND PRECAUTIONS]
  • Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]

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 [see WARNINGS AND PRECAUTIONS].

Read the Bactroban Cream (mupirocin calcium cream) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/11/2016

Side Effects
Interactions

Bactroban Ointment - User Reviews

Bactroban Ointment User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Bactroban Ointment sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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