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Last reviewed on RxList: 1/9/2017
Efudex Side Effects Center

Last reviewed on RxList 10/03/2016

Efudex (fluorouracil) topical contains an antineoplastic antimetabolite used to treat scaly overgrowths of skin (actinic or solar keratoses). Efudex may also be used in the treatment of superficial basal cell carcinoma. It works by causing the death of cells that are growing fastest, such as abnormal skin cells. Efudex is available in generic form. Common side effects of Efudex include:

  • skin irritation,
  • burning,
  • redness,
  • dryness,
  • pain,
  • swelling,
  • tenderness,
  • scaling,
  • peeling (exfoliation),
  • rash,
  • changes in skin color at the site of application, or other local reactions.
  • Other side effects of Efudex include eye irritation (e.g., stinging, watering),
  • trouble sleeping,
  • irritability,
  • temporary hair loss, or
  • abnormal taste in the mouth.

Tell your doctor if you have rare but very serious side effects of Efudex including:

  • stomach or abdominal pain,
  • bloody diarrhea,
  • vomiting,
  • signs of infection (e.g., fever, chills, persistent sore throat),
  • easy bruising or bleeding, or
  • mouth sores.

The dose of Efudex topical is to apply a small amount of the cream to the area that is to be treated, once or twice daily after cleansing. Treatment lasts 2-6 weeks depending on the condition being treated. Wash hands immediately afterward. Do not use other prescription or over-the-counter skin products without first talking to your doctor during treatment with Efudex topical. They may interfere with treatment or increase irritation to the skin. Other drugs may also interact with Efudex topical. Talk to your doctor before taking any prescription or over-the-counter medicines. Efudex topical must not be used during pregnancy. It may harm a fetus. It is not known if this medication passes into breast milk. Due to the potential risk to a nursing infant, breastfeeding is not recommended while using this drug.

Our Efudex (fluorouracil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Efudex Consumer Information

Serious side effects are not likely to occur. Stop using fluorouracil topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Fluorouracil topical may cause skin irritation, dryness, scaling or peeling (exfoliation), rash, and other local reactions. Eye irritation has also been reported. If these side effects are excessive or worsen with continued treatment, contact your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Efudex (Fluorouracil)

Efudex Professional Information


The most frequent adverse reactions to Efudex occur locally and are often related to an extension of the pharmacological activity of the drug. These include burning, crusting, allergic contact dermatitis, pruritus, scarring, rash, soreness, and ulceration. Ulcerations, other local reactions, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when Efudex was applied to mucous membrane areas. Leukocytosis is the most frequent hematological side effect. Although a causal relationship is remote, other adverse reactions which have been reported infrequently are:

Central Nervous System: Emotional upset, insomnia, irritability.

Gastrointestinal: Medicinal taste, stomatitis.

Hematological: Eosinophilia, thrombocytopenia, toxic granulation.

Integumentary: Alopecia, blistering, bullous pemphigoid, discomfort, ichthyosis, scaling, suppuration, swelling, telangiectasia, tenderness, urticaria, skin rash.

Special Senses: Conjunctival reaction, corneal reaction, lacrimation, nasal irritation.

Miscellaneous: Herpes simplex.

To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 and/or FDA at 1-800-FDA-1088 or

Read the entire FDA prescribing information for Efudex (Fluorouracil)

Related Resources for Efudex

Read the Efudex User Reviews »

© Efudex Patient Information is supplied by Cerner Multum, Inc. and Efudex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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