BACTROBAN NASAL SIDE EFFECTS
- Generic Name: mupirocin calcium ointment
- Brand Name: Bactroban Nasal
- Drug Class: Antibacterials, Topical
SIDE EFFECTS
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Systemic 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 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 Less than 1% of domestic or foreign subjects in clinical trials were withdrawn due to adverse reactions.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% |
| Taste 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.
SRC: NLM .