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Efudex Side Effects

Generic name: fluorouracil topical

Medically reviewed by Drugs.com. Last updated on Apr 24, 2022.

Note: This document contains side effect information about fluorouracil topical. Some of the dosage forms listed on this page may not apply to the brand name Efudex.

For the Consumer

Applies to fluorouracil topical: topical cream, topical solution

Side effects requiring immediate medical attention

Along with its needed effects, fluorouracil topical (the active ingredient contained in Efudex) may cause some unwanted 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 any of the following side effects occur while taking fluorouracil topical:

Incidence not known

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest pain
  • chills
  • cough
  • fever
  • painful or difficult urination
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • swollen glands
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Side effects not requiring immediate medical attention

Some side effects of fluorouracil topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

  • Dry, rough, or scaly skin
  • loss or thinning of the hair
  • raised, dark red, wart-like spots on the skin, especially when used on the face
  • swelling or inflammation of the mouth
  • tearing of the eyes
  • trouble sleeping

For Healthcare Professionals

Applies to fluorouracil topical: topical cream, topical kit, topical solution

Dermatologic

Very rare (less than 0.01%): Pruritus, urticaria, rash (local or generalized), erythema (i.e., erythema multiforme), burning sensation, exfoliation, swelling, ulceration, allergic contact dermatitis, eczema, blistering, alopecia, pain

Frequency not reported: Hyperpigmentation, crusting, irritation, photosensitivity, scarring, bullous pemphigoid, ichthyosis, scaling, suppuration, telangiectasia, tenderness, herpes simplex[Ref]

Gastrointestinal

Very rare (less than 0.01%): Diarrhea, vomiting, abdominal pain, stomatitis, mucosal inflammation

Frequency not reported: Nausea, medicinal taste[Ref]

Hematologic

Frequency not reported: Leukocytosis, eosinophilia, thrombocytopenia, toxic granulation[Ref]

Hypersensitivity

Very rare (less than 0.01%): Hypersensitivity[Ref]

Nervous system

Frequency not reported: Dysgeusia, headache, dizziness[Ref]

Ocular

Frequency not reported: Conjunctival irritation, corneal reaction, keratitis, increased lacrimation[Ref]

Other

Very rare (less than 0.01%): Pyrexia, chills[Ref]

Respiratory

Frequency not reported: Nasal irritation[Ref]

Psychiatric

Frequency not reported: Emotional upset, irritability, insomnia[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Fluorouracil Topical (fluorouracil topical)." A-S Medication Solutions (2017):

4. "Product Information. Tolak (fluorouracil topical)." Hill Dermaceuticals Inc (2017):

5. "Product Information. Efudex (fluorouracil topical)." Valeant Pharmaceuticals (2017):

6. "Product Information. Fluoroplex (fluorouracil topical)." Aqua Pharmaceuticals LLC (2017):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.