Adverse reactions : תופעות לוואי

4.8 Undesirable effects

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 the 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

Immune system disorders
Rare (≥1/10,000 and <1/1,000):
Hypersensitivity

Eye Disorders

Rare (≥1/10,000 and <1/1,000):
Conjunctivitis

Skin and subcutaneous tissue disorders
Uncommon (≥1/1,000 and <1/100):
Dermatitis (including dermatitis contact, eczema)
Rash*
Pruritus
Erythema

* Various types of rash reactions such as erythematous, pustular, vesicular, maculo-papular and papular have been reported. Rash generalised has also occurred.


Rare (≥ 1/10,000 and < 1/1,000)
Angioedema
Urticaria
Blister
General disorders and administration site conditions Uncommon (≥1/1,000 and <1/100)
Application site pain (including skin burning sensation) Application site irritation

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


Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffec tMedic@moh.gov.il