Fucidin Adverse Reactions

Cream: Like all medicines, this medicine can cause side effects, although not everybody gets them. In clinical trials, approximately 2 out of every 100 patients got a side effect. The most frequent side effects are non-serious skin problems where the cream is used and these occur in approximately 1 out of every 100 patients.
Important side effects to look out for: The patient must get urgent medical help straight away if he/she has any of the following symptoms: The patient may be having an allergic reaction. This is rare (may affect up to 1 in 1000 people).
The patient has difficulty breathing.
Lips and mouth start to tingle or swell.
Face or throat swell.
Skin develops a severe rash.
Other possible side effects which are less serious can also occur. The patient should tell the doctor about these as soon as possible.
Uncommon (may affect up to 1 in 100 people): Rash or itch; Redness of the skin; Itchy red rash with heat and swelling in the area where the cream is used (contact dermatitis or eczema); Pain, irritation (stinging) or burning in the area where the cream is used.
Rare (may affect up to 1 in 1000 people): The eye might get very itchy and have a watery discharge; Swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing; Hives or blisters.
These side effects may also occur in children who use the product.
Ointment: The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.
Based on pooled data from clinical studies including 4724 patients who received Fucidin cream or Fucidin ointment, the frequency of undesirable effects is 2.3%.
The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by various application site conditions such as pain and irritation, which all occurred in less than 1% of patients.
Hypersensitivity and angioedema have been reported.
Undesirable effects are listed by MedDRA System Organ Class (SOC) and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000. (See table.)

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Paediatric population: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.