Bactroban Side Effects

Please note - some side effects for Bactroban may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Bactroban - for the Consumer

Bactroban Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bactroban Cream:

Burning; headache; nausea; stinging.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe irritation; severe itching.

Bactroban Nasal Ointment

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bactroban Nasal Ointment:

Burning; change in sense of taste; congestion; cough; headache; sore throat; stinging; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe irritation; severe itching.

Bactroban Ointment

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bactroban Ointment:

Burning; pain; stinging.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe irritation; severe itching.

Bactroban Side Effects - for the Professional

Bactroban Nasal Ointment

Clinical Trials:

In clinical trials, 210 domestic and 2,130 foreign adult subjects/patients received Bactroban NASALointment. Less than 1% of domestic or foreign subjects and patients in clinical trials were withdrawn due to adverse events.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 NASALointment 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

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 NASALointment, 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.

Side Effects by Body System

Local

Local adverse effects may be associated with mupirocin application. Mupirocin ointment or cream may commonly cause itching, pain, stinging, and burning. Local effects from the nasal formulation have included epistaxis, rhinitis, taste perversion, pharyngitis, burning, and cough.

Mupirocin ointment in a polyethylene glycol base has previously (prior to the release of a nasal formulation) been used intranasally. Common side effects associated with such use, which may be related to the polyethylene glycol, include nasal congestion, dryness, burning or irritation and unpleasant taste.

Gastrointestinal

Gastrointestinal side effects have included nausea (1.1%), abdominal pain (<1%), and diarrhea (<1%). Dry mouth has been reported with mupirocin nasal (<1%).

Hypersensitivity

Hypersensitivity reactions have infrequently included allergic contact dermatitis.

Nervous system

Nervous system side effects associated with intranasal mupirocin have included headache (9%). Dizziness has been reported with mupirocin ointment (<1%).

Ocular

Ocular side effects associated with mupirocin nasal ointment have included blepharitis (<1%).

Dermatologic

Dermatologic side effects associated with mupirocin ointment or cream have included pain and bleeding secondary to eczema, cellulitis, dermatitis, increased exudate, secondary wound infection, hives, and rash.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.