March 28, 2017
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Bactroban Ointment

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Bactroban Ointment




Bactroban Ointment Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/28/2016

Bactroban Ointment (mupirocin ointment) is a topical (for the skin) antibiotic used to treat infections of the skin such as impetigo. Bactroban Ointment is available in generic form. Common side effects of Bactroban Ointment include:

  • burning
  • stinging
  • itching
  • redness, or
  • pain at first as your body adjusts to it.
Other side effects of Bactroban Ointment include:
  • nausea
  • dry skin
  • tenderness
  • swelling
  • increased pus, and
  • allergic reactions (including anaphylaxis, hives, skin swelling, and generalized rash)

A small amount of Bactroban Ointment should be applied to the affected area three times daily. The area treated may be covered with gauze dressing. Other topical medications may change the way your skin absorbs Bactroban Ointment. Avoid using other products on the same area at the same time unless directed to do so by your doctor. Tell your doctor all medications you use. Bactroban Ointment should be used only when prescribed during pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Bactroban Ointment (mupirocin ointment) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Bactroban Ointment in Detail - Patient Information: Side Effects

Serious side effects are not expected to occur with mupirocin topical therapy. Stop using mupirocin topical and see your doctor if you experience unusual blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Bactroban Ointment (Mupirocin)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Bactroban Ointment Overview - Patient Information: Side Effects

SIDE EFFECTS: This medication may cause burning, stinging, itching or pain at first as your body adjusts to it. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A small amount of this medication may be absorbed into your bloodstream and may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur while receiving treatment or even weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in a new infection (e.g., fungal infection). Contact your doctor if you notice signs of a new infection.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Bactroban Ointment (Mupirocin)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Bactroban Ointment FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

  • Systemic 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 clinical trials, 210 domestic (US) and 2,130 foreign adult subjects received BACTROBAN nasal ointment. Less than 1% of domestic or foreign subjects in clinical trials were withdrawn due to adverse reactions.

The most frequently reported adverse reactions in foreign clinical trials were rhinitis (1%), taste perversion (0.8%), and pharyngitis (0.5%).

In domestic clinical trials, 17% (36 of 210) of adults treated with BACTROBAN nasal ointment reported adverse reactions thought to be at least possibly drug related. Table 1 shows the incidence of adverse reactions that were reported in at least 1% of adults enrolled in clinical trials conducted in the US.

Table 1: Adverse Reactions ( ≥ 1% Incidence) - Adults in US Trials

Adverse Reactions % of Subjects Experiencing Reactions BACTROBAN Nasal Ointment
(n = 210)
Headache 9%
Rhinitis 6%
Respiratory disorder, including upper respiratory tract congestion 5%
Pharyngitis 4%
T aste perversion 3%
Burning/stinging 2%
Cough 2%
Pruritus 1%

The following adverse reactions 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.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of BACTROBAN nasal ointment. 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 nasal ointment.

Immune System Disorders

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Bactroban Ointment (Mupirocin)

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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