Efudex contains the active ingredient fluorouracil in the form of a cream with 5% strength. Fluorouracil acts as an antineoplastic antimetabolite. The formulation is intended for topical use and includes inactive ingredients such as methylparaben, polysorbate 60, and white petrolatum.

How should I use this medication?

This medication is for external use only. Do not take it by mouth. Wash your hands before and after use. Do not get it in your eyes. If you do, rinse your eyes with plenty of cool tap water. Use it as directed on the prescription label at the same time every day. Do not use it more often than directed. Use it for the full course as directed by your care team, even if you think you are better. Do not stop using it unless your care team tells you to stop it early. Apply a thin film of the medication to the affected area. You can cover the area with a sterile gauze dressing (bandage). Do not use an airtight bandage (such as a plastic-covered bandage). Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets. See product for storage information. Each product may have different instructions. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Painful swelling, warmth, or redness of the skin, blisters or sores Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Mild skin irritation, redness, or dryness -Skin reactions on sun-exposed areas

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Dihydropyrimidine dehydrogenase (DPD) deficiency -An unusual or allergic reaction to fluorouracil, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Interactions are not expected. Do not use any other skin products on the same area of skin without talking to your care team.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication. Make sure you know what you are using this medication for. It comes in different strengths. Make sure you have the correct strength. All strengths can be used for sun spots. Only the 5% products are used for skin cancer. Treated areas of skin can look unsightly during and for several weeks after treatment with this medication. Do not get this medication in your eyes. If you do, rinse out with plenty of cool tap water. This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths. Serious side effects or death can occur if a pet comes into contact with this medication. Contact a vet right away if a pet touches or licks the medication on your skin or comes into contact with the container. Get rid of or wash any items used to apply this medication. Wash your hands after applying the medication. Make sure the medication does not get on clothing, carpet, or furniture. If you cannot avoid skin to skin contact with your pet, ask your care team if you can cover the area(s) where you apply this medication. Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy. Contraception is recommended while taking this medication. Your care team can help you find the option that works for you. Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.