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
Frequency not known: Conjunctival irritation, keratitis, lacrimation increased
Very rare: Hemorrhagic diarrhoea, diarrhoea, vomiting, abdominal pain, stomatitis, associated with systemic drug toxicityFrequency not known: Nausea
Skin and subcutaneous tissue disorders
Very rare: Erythema multiforme, pain of skin, skin reactions (e.g. urticaria, pruritus, rash (usually local but also generalised if associated with systemic drug toxicity)), dermatitis, contact dermatitis, eczema, application site vesicles, skin irritation, erythema, skin burning sensation, skin exfoliation, skin swelling, skin ulcer, photosensitivity reaction, alopecia
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
Reporting of suspected adverse reactions
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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: firstname.lastname@example.org.