Examples

Fluorouracil has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of genital warts. Using fluorouracil to treat genital warts is an unlabeled use of the medicine.

Application of 5% cream

Fluorouracil is applied 1 to 3 times a week for several weeks as needed to clear the warts. To decrease skin sensitivity, the cream can be washed off 3 to 10 hours after application.

The surrounding normal tissue can be protected with petroleum jelly (such as Vaseline) or another ointment to prevent irritation. For men, the skin at the tip of the penis should be protected with an ointment.

You should not wear tight-fitting underwear because it might smear the medicine to other areas.

A skin reaction may not occur until 3 to 4 days after application. If the reaction is severe, you should stop treatment.

How It Works

Fluorouracil prevents human papillomavirus (HPV), which causes genital warts, from reproducing.

Why It Is Used

Fluorouracil is used after other treatment options have failed. Fluorouracil is not the first medicine doctors recommend for genital warts.

Fluorouracil may be used at home after a doctor shows you how to apply it.

Fluorouracil may be most useful for treating warts on the vulva, penis, and anal area and at the opening to the urethra.

How Well It Works

Fluorouracil may initially remove warts, but studies have not completely evaluated its effectiveness.¹

Side Effects

Fluorouracil treatment may cause:

• Severe skin irritation and ulcers, which may develop in the treated area.
• Pain during urination if the urethra is treated.
• Shedding of dead tissue.

See Drug Reference for a full list of side effects. (Drug Reference is not available in all systems.)

What To Think About

Fluorouracil is not used to treat genital warts during pregnancy. A woman should use birth control to prevent pregnancy during fluorouracil therapy because it can be harmful to the fetus.

Fluorouracil is not FDA-approved for treating genital warts. Because of the risk of severe skin irritation, doctors prescribe fluorouracil only if other treatments have failed. Fluorouracil should be prescribed only by doctors who are experienced in using it.

Fluorouracil treatment can be used along with laser surgery to improve the effectiveness of treatment.

Some people are not able to complete treatment because they have a severe skin reaction.

Genital warts may go away without treatment. Also, treating warts does not cure a human papillomavirus (HPV) infection, the virus that causes genital warts. The virus may remain in the body in an inactive state after warts are removed. A person treated for genital warts may still be able to spread the infection. Condoms may help reduce the risk of HPV infection.

The benefits and effectiveness of each type of treatment need to be compared with the side effects and cost. Discuss this with your doctor.

Complete the new medication information form (PDF)(What is a PDF document?) to help you understand this medication.