Efudex Cream (Fluorouracil)

(℞) Prescription Required

    Efudex Cream (fluorouracil) Dosage and Side Effects

    When applied to the skin, it is used to treat certain skin problems, including cancer or conditions that could become cancerous if not treated.  Efudex interferes with the growth of abnormal cells, which are eventually destroyed. 

    Warnings and Precautions

    Before Using EFUDEX:

    For EFUDEX (fluorouracil), the following should be considered and discussed with your physician before using this medication:


    Tell your physician if you have ever had any unusual or allergic reaction to fluorouracil or any of EFUDEX components.


    Tell your physician if you are pregnant or if you intend to become pregnant. Although EFUDEX applied to the skin has not been shown to cause problems in humans, some of it is absorbed through the skin and there is a chance that it could cause birth defects. Be sure that you have discussed this with your doctor before using this medication.


    Although EFUDEX applied to the skin has not been shown to cause problems in nursing babies, some of it is absorbed through the skin.


    There is no specific information comparing the use of EFUDEX on the skin in children with the use in other age groups.

    Older adults:

    Many medications have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing the use of EFUDEX on the skin in the elderly with the use in other age groups, this medication is not expected to cause different side effects or problems in older people than it does in younger adults.

    Other medical problems:

    The presence of other medical problems may affect the use of EFUDEX on the skin. Make sure you tell your physician if you have any other medical problems, especially since other skin problems may be aggravated.

    It is very important that your doctor checks your progress at regular visits to make sure that EFUDEX is working properly and to check for unwanted effects.

    Apply EFUDEX very carefully when using it on your face. Avoid getting any into your eyes, nostrils, or mouth.

    While using EFUDEX, and for 1 or 2 months after you stop using it, your skin becomes more sensitive to sunlight than usual and too much sunlight may increase the effect of EFUDEX. During this period of time:

    Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.

    • Wear protective clothing, including a hat and sunglasses.
    • Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your physician or pharmacist.
    • Do not use a sunlamp or tanning bed or booth.

    If you have a severe reaction from the sun, consult with your doctor.

    Side Effects

    Along with its needed effects, a medication may cause some unwanted side effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if the following side effects occur: redness and swelling of normal skin.

    Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medication. However, check with your doctor if any of the following side effects continue, worsen, or are bothersome: More common: burning sensation where medication is applied; increased sensitivity of skin to sunlight; oozing; skin rash; soreness or tenderness of skin. Less common or rare: darkening of skin; scaling; watery eyes.

    Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

    Proper Use of this medication

    Keep using EFUDEX (fluorouracil) for the full length of treatment. However, do not use EFUDEX more often or for a longer time than your doctor ordered. Apply enough medication each time to cover the entire affected area with a thin layer.

    After washing the area with soap and water and drying carefully, use a cotton-tipped applicator or wear suitable gloves to apply the medication in a thin layer to your skin. EFUDEX should be applied with care near the eyes, nostrils and mouth.

    EFUDEX may cause redness, soreness, scaling, and peeling of affected skin after 1 or 2 weeks of use. This effect may last for several weeks after you stop using EFUDEX and is to be expected. Sometimes a pink, smooth area is left when the skin treated with EFUDEX heals. This area will usually fade after 1 to 2 months. Do not stop using EFUDEX without first checking with your doctor. If the reaction is very uncomfortable, check with your doctor.

    The dose of Efudex (fluorouracil) will vary for different patients. Follow your doctor's recommendations or the directions on the label. The following information includes only the average doses of fluorouracil. If your dose is different, do not change it unless your doctor tells you to do so.

    Efudex (fluorouracil) 5 %:

    Efudex is recommended for the topical treatment of premalignant keratoses and superficial basal cell carcinoma.

    • Adults: Apply 5 % cream on the affected areas of skin two times daily.

    • Children: Use and dose must be determined by your doctor.

    Missed Dose:

    If you miss a dose of Efudex (fluorouracil), apply it as soon as you remember. However, if more than a few hours have passed, skip the missed dose and go back to your regular dosing schedule. If you miss more than one dose, check with your doctor.

    Other related products

    The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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