Efudix 5% cream – fluorouracil for actinic keratoses and superficial skin lesions

Efudix is a cream for use on the skin that contains 5% fluorouracil (50 mg per 1 g of cream). Fluorouracil belongs to a group of medicines used to treat cancer – in the cream it destroys precancerous and malignant skin cells while having little effect on healthy cells.

According to the leaflet, Efudix is used for topical treatment of superficial premalignant and malignant skin conditions, such as actinic (solar) and senile keratoses, keratoacanthoma, Bowen’s disease and superficial basal cell carcinoma. Redness and inflammation of the treated skin during treatment are an expected sign that the medicine is working.

What is Efudix cream used for and how is it applied correctly?

Key facts about the medicine

What is Efudix used for?

According to the leaflet, Efudix is intended for topical treatment of superficial premalignant and malignant skin conditions:

• keratoses – senile, actinic and arsenical forms;
• keratoacanthoma;
• Bowen’s disease;
• superficial basal cell carcinoma.

Deep, penetrating or nodular basal cell carcinoma and squamous cell carcinomas usually do not respond to Efudix – in these cases it is used only as palliative treatment if no other treatment is possible. Efudix also acts on changes that are not yet visible to the naked eye, so these areas of skin may also become red and inflamed.

How is it applied and dosed?

Always use the cream exactly as your doctor has told you – the doctor determines the site, frequency and duration of treatment.

• The cream is usually applied once or twice daily for at least three to four weeks.
• Apply a thin layer only to the affected area of skin; avoid contact with the eyes and mouth and take particular care around the eyes, nose and lips.
• Do not use too much cream and do not apply it to open wounds – a larger amount of medicine may then reach the bloodstream.
• Never apply the cream to an area larger than 23 x 23 cm at a time (roughly the size of a plate).
• Wash your hands thoroughly after each application.
• Your doctor will tell you whether the treated area should be covered with a dressing – occlusive dressings can intensify the inflammatory reaction.

Typical course: the treated skin becomes red, followed by inflammation and swelling, possible discomfort, skin erosion and finally healing. After treatment ends, the skin may need one to two months to recover fully. If you feel the medicine is acting too strongly or too weakly, talk to your doctor – do not change the dose yourself.

Special patient groups

• Children and adolescents: Efudix is not intended for people under 18 years of age.
• DPD enzyme deficiency: people with reduced activity or absence of the enzyme dihydropyrimidine dehydrogenase (DPD) should talk to their doctor before use.
• Fertility: the medicine may affect fertility in women and men and is not recommended for men trying to father a child.

Contraindications – when the medicine must not be used

Do not use Efudix:

• if you are allergic to fluorouracil or any of the excipients;
• if you are pregnant, think you may be pregnant or are breast-feeding;
• if you are using antiviral nucleoside analogues, e.g. brivudine or sorivudine (medicines for chickenpox and shingles).

Warnings and precautions

• Sun and sunbeds: sunlight can increase the effect of the medicine and the skin reaction – avoid direct sun exposure, do not sunbathe and do not use sunbeds during treatment.
• Fire hazard: do not smoke or go near naked flames. Clothing, bedding and covers that have been in contact with the cream burn more easily; washing reduces, but does not completely remove, the build-up of the medicine.
• Eyes, nose and mouth: if the cream gets into the eyes, nose or mouth, rinse it off with water and contact a doctor, pharmacist or the nearest hospital; the same applies if someone else uses the medicine by accident.
• Open wounds: do not apply the cream to open wounds.
• Excipients: stearyl alcohol and propylene glycol may cause local skin irritation (e.g. contact dermatitis), and methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions, possibly delayed.

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you are taking. It is particularly important if you are taking, or have taken in the last 4 weeks, medicines for chickenpox or shingles – brivudine or sorivudine. They can increase the likelihood of side effects of fluorouracil, and using them at the same time as the cream is contraindicated.

Pregnancy and breast-feeding

• Pregnancy: Efudix must not be used if you are pregnant, think you may be pregnant or are planning a pregnancy. Use effective contraception during treatment; if you become pregnant, tell your doctor immediately and attend genetic counselling.
• Breast-feeding: the medicine must not be used while breast-feeding; if use is absolutely necessary, breast-feeding must be stopped.

Driving and using machines

According to the leaflet, treatment with Efudix cream is unlikely to affect the ability to drive or use machines.

Possible side effects

The expected response to treatment is redness, inflammation and swelling of the treated skin, discomfort, erosion and then healing – this shows that the medicine is working. Sometimes the reaction is stronger; if your skin gets worse, you feel pain or you are worried, contact your doctor, who may prescribe a cream to relieve the symptoms.

• Tell your doctor immediately if you get stomach problems (pain, cramps, diarrhoea, vomiting), swelling and soreness of the mouth and tongue, fever or feel generally unwell – these may occur if too much cream is used or it is applied to open wounds.
• Very rare (up to 1 in 10,000): blood disorders due to systemic toxicity (pancytopenia, neutropenia, thrombocytopenia); more severe skin reactions at the treated site – itching, redness, burning, severe peeling, intense swelling or inflammation, ulceration, blisters, irritation, pain, hives or rash (sunlight may intensify them); rash in areas where the cream was not applied; hair loss.
• Not known: sore and/or watery eyes, taste disturbance, headache, dizziness, nausea.

Overdose, missed dose and stopping treatment

• Too much cream or accidental swallowing: if you accidentally swallow the cream, contact a doctor or pharmacist immediately or go to the nearest hospital. Too much cream or application to open wounds may cause stomach problems, mouth sores and fever.
• Missed dose: apply the cream as soon as you remember; if it is almost time for the next application, skip the missed one. Do not apply a double amount.
• Duration and stopping: treatment usually lasts at least 3–4 weeks; the duration and end of treatment are decided by the doctor.

Related information

For protecting your skin from the sun during and after treatment, see also the category Sunscreens and sun protection – products in this category do not replace the medicine prescribed for you; do not apply them to eroded treated skin without your doctor’s advice.

Composition, pack and manufacturer

• Active substance: fluorouracil – 50 mg per 1 g of cream (5%).
• Excipients: stearyl alcohol; white soft paraffin; polysorbate 60; propylene glycol; methyl parahydroxybenzoate (E218); propyl parahydroxybenzoate (E216); purified water.
• Pack: aluminium tube containing 20 g or 40 g of cream with a plastic screw cap, in a carton.
• Manufacturer: ICN Polfa Rzeszów S.A., Przemysłowa 2, Rzeszów, Poland. Marketing authorisation holder according to the 2019 leaflet: Predstavništvo BGP Products Switzerland GmbH Belgrade; according to the ALIMS list of authorisation transfers dated 07.07.2021: Viatris Healthcare d.o.o., Belgrade.

Storage

• Store below 30 °C, out of the sight and reach of children.
• Shelf life after first opening of the tube: 90 days, stored below 30 °C.
• Do not use after the expiry date; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Is it normal for the skin to become red and sore during Efudix treatment?

Yes. According to the leaflet, redness, inflammation, swelling, discomfort and skin erosion are the expected response and a sign that the medicine is working, followed by healing. If the reaction is very strong, painful or spreading, contact your doctor.

How long is Efudix applied?

Usually once or twice daily for at least three to four weeks – the exact duration is decided by your doctor. After treatment the skin may need one to two months to recover fully.

May I sunbathe while using Efudix?

No. Sunlight intensifies the skin reaction to the medicine, so direct sun, sunbathing and sunbeds should be avoided during treatment.

Can I use Efudix if I am planning a pregnancy?

Not without talking to your doctor. The medicine must not be used during pregnancy and breast-feeding, effective contraception is needed, and it is also not recommended for men trying to father a child.

Sources

• ALIMS – Summary of Product Characteristics, Efudix® 5% cream (SmPC, Serbian)
• ALIMS – Patient leaflet, Efudix® 5% cream (PIL, October 2019, Serbian)

Sources checked on: 25 October 2026.