Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.
Ointment: Common and uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 1573 treated patients encompassing 12 clinical studies.
Immune system disorders: Very rare: Systemic allergic reactions including anaphylaxis, generalized rash, urticaria and angioedema have been reported with Bactroban Ointment.
Skin and subcutaneous tissue disorders: Common: Burning localised to the area of application.
Uncommon: Itching, erythema, stinging and dryness localised to the area of application. Cutaneous sensitisation reactions to mupirocin or the ointment base.
Nasal ointment: Uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 422 treated patients encompassing 12 clinical studies.
Immune system disorders: Very rare: Cutaneous hypersensitivity reactions.
Respiratory, thoracic and mediastinal disorders: Uncommon: Nasal mucosa reactions.
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