Adverse reactions are listed as follows by system organ class and frequency. Frequencies are defined as: very common (greater than or equal to 1/10), common (greater than or equal to 1/100, less than 1/10), uncommon (greater than or equal to 1/1000, less than 1/100), rare (greater than or equal to 1/10,000, less than 1/1000), very rare (less than 1/10,000), including isolated reports.
Cream: Data from clinical trials was used to determine the frequency of very common to rare undesirable effects.
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. Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.
Skin and subcutaneous tissue disorders: Common: Cream: Cutaneous hypersensitivity reactions.
Ointment: 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.
Immune system disorders: Very rare: Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported with BACTROBAN ointment.