Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories:
Very common (≥ 1/10)
Common (≥ 1/100 to <1/10)
Uncommon (≥ 1/1,000 to <1/100)
Rare (≥ 1/10,000 to <1/1,000)
Very rare (<1/10,000)
Frequency not known (cannot be estimated from the available data) 
Adverse reactions associated with exacerbations of normal pattern of response (see section 4.4) which are related to pharmacological activity of fluorouracil on the skin are the most frequently reported reactions. Allergic type skin reactions and reactions related to systemic drug toxicity are very rarely reported.

Blood and lymphatic system disorders

Very rare: Haematological disorders, associated with systemic drug toxicity, e.g. pancytopenia, neutropenia, thrombocytopenia, leukocytosis.

Immune system disorders

Very rare: Allergic conditions (e.g., Hypersensitivity and Type IV hypersensitivity).

Nervous system disorders

Frequency not known: Dysgeusia, headache, dizziness.
Eye disorders

Frequency not known: Conjunctival irritation, keratitis, increased lacrimation.

Gastrointestinal disorders

Very rare: Diarrhoea haemorrhagic, diarrhoea, vomiting, abdominal pain, stomatitis, associated with systemic drug toxicity.

Frequency not known: Nausea.

Skin and subcutaneous tissue disorders
Very rare: Pruritus, urticaria, rash (usually local but also generalised if associated with systemic drug toxicity); erythemas including erythema multiforme; dermal and epidermal conditions (such as skin burning sensation, skin exfoliation, skin swelling); skin and subcutaneous skin ulcerations; dermatitis and eczema conditions (such as contact dermatitis, skin irritation); blisters, and alopecia.

Exposure to sunlight may increase the intensity of the reaction.

See also normal pattern of response in section 4.4
General disorders and administration site conditions 
Very rare: Pyrexia, chills and mucosal inflammation, associated with systemic drug toxicity.
Frequency not known: Application site haemorrhage


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 https://sideeffects.health.gov.il