Adult dose and duration5% cream. SmPC verbatim for a malignant lesion: "The cream should be applied once or twice daily under an occlusive dressing where this is practicable." "Treatment should be continued until there is marked inflammatory response from the treated area, preferably with some erosion in the case of pre-malignant conditions." "The usual duration of treatment for an initial course of therapy is three to four weeks, but this may be prolonged." Never treat a large area at once: "The total area of skin being treated with this medicine at any one time should not exceed 500 cm 2 (approximately 23 x 23 cm). Larger areas should be treated a section at a time." "The hands should be washed carefully after applying this medicine. Also care should be taken to avoid contact with mucous membranes or the eyes when applying the cream." Healing lags behind the course: "Lesions on the face usually respond more quickly than those on the trunk or lower limbs whilst lesions on the hands and forearms respond more slowly. Healing may not be complete until one or two months after therapy is stopped." - Three to four weeks for an initial course; may be prolonged
Paediatric doseNot a paediatric treatment. SmPC verbatim: "In view of the lack of clinical data available, fluorouracil is not recommended for use in children." Basal cell carcinoma is in any case a disease of sun-damaged adult skin.
Dose sourceEfudix 5% cream (fluorouracil) SmPC sections 4.1, 4.2, 4.3 and 4.4 (eMC product 9260, emc-efudix-5pct-fluorouracil.txt)
WhyAdded under the August 2026 ruling that the no-cytotoxic policy targets systemic chemotherapy, not a topical dermatology cream for a lesion already confirmed on biopsy; the earlier refusal had rested on a rule aimed at intravenous oncology. StatPearls lists topical 5-fluorouracil beside imiquimod 5% cream, both carrying FDA approval for superficial BCC. The cream's licensed uses go beyond this one diagnosis: the label also covers Bowen's disease, keratoacanthoma, and senile, actinic or arsenical keratoses, alongside superficial basal cell carcinoma itself, and it sets out how to apply it. Surgery stays the definitive treatment and remains first line. Egypt's single topical 5-FU product, EZADEX 5% cream 20 g, is currently marked not available; intravenous fluorouracil vials and ampoules are excluded by name so that a skin cream can never offer a chemotherapy infusion.
Cautions- BIOPSY FIRST, ALWAYS, and only for a SUPERFICIAL lesion. Every suspected lesion goes for histology first, to confirm what it is and to direct the treatment. The label is explicit that the deeper tumours do not respond: a basal cell or squamous cell carcinoma that is nodular, or that penetrates deeply, will generally not answer to fluorouracil at all, and using it there is palliation only - reserved for a patient for whom nothing else can be done.
- CONTRAINDICATED IN PREGNANCY AND BREASTFEEDING. The SmPC bars fluorouracil outright for a woman who is pregnant and for one who is breastfeeding.
- CONTRAINDICATED WITH BRIVUDINE AND ITS ANALOGUES, and the interval is four weeks either way. Giving fluorouracil alongside an antiviral nucleoside - brivudine and the drugs like it - can push its plasma concentration up sharply, with the toxicity that follows, and the SmPC forbids the combination.
- FIRE HAZARD - this is not a routine cream warning. Tell the patient NOT to smoke and NOT to go near an open flame: the burns risked are severe. Anything woven that has touched the cream - clothes, bed linen, a dressing - catches fire more readily, and that is a genuine danger.
- Warn the patient what the skin will look like or they will stop the course. The expected sequence runs in three stages: first inflammation, severe, with redness that can turn intense and patchy; then a necrotic stage in which the skin erodes; then healing, as the surface re-epithelialises. It usually declares itself in the second week on fluorouracil, and it can go further than that - pain, blisters, ulceration. STOP APPLYING IT - do NOT put on any more fluorouracil where the inflammation is severe enough to blister or ulcerate. For discomfort short of that, an appropriate topical steroid cream may settle it.
- Keep the treated skin out of the sun. Ultraviolet exposure is to be avoided - daylight itself, and a tanning booth equally.
- DPD deficiency turns a skin cream into a systemic poisoning. Toxicity has been reported to run higher where the enzyme dihydropyrimidine dehydrogenase works at reduced capacity. Occlusion and broken skin both raise absorption, so a patient who becomes systemically unwell during treatment stops it and is investigated.
- SURGERY REMAINS THE DEFINITIVE TREATMENT, and topical therapy buys no histology. Treating from the surface has a real drawback: you get neither certainty that every tumour cell has gone, nor a specimen to confirm it. Follow the lesion up; if it is not clear, it goes to surgery.
- EGYPTIAN AVAILABILITY, STATED PLAINLY: the only topical fluorouracil product in the 25,070-product register is EZADEX 5% cream 20 g, and the register marks it NOT AVAILABLE. Every other fluorouracil product in Egypt is an intravenous chemotherapy vial or ampoule and is deliberately hidden from this row. Imiquimod, on the row above, is stocked.