"The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these product"...
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 Less than 1% of domestic or foreign subjects in clinical trials were withdrawn due to adverse reactions.
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)
|Respiratory disorder, including upper respiratory tract congestion||5%|
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.
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
Read the Bactroban Nasal (mupirocin calcium ointment) Side Effects Center for a complete guide to possible side effects
No information provided.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/26/2015
Additional Bactroban Nasal Information
Bactroban Nasal - User Reviews
Bactroban Nasal User Reviews
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