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Efudex Side Effects

Generic Name: fluorouracil topical

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

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:

  • Redness and swelling of normal skin

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:

More common
  • Burning feeling where medicine is applied
  • increased sensitivity of skin to sunlight
  • itching
  • oozing
  • skin rash
  • soreness or tenderness of skin
Less common or rare
  • Darkening of skin
  • scaling
  • watery eyes

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. "Product Information. Tolak (fluorouracil topical)." Hill Dermaceuticals Inc, Sanford, FL.

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

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

4. "Product Information. Fluoroplex (fluorouracil topical)." Aqua Pharmaceuticals LLC, Malvern, PA.

5. "Product Information. Fluorouracil Topical (fluorouracil topical)." A-S Medication Solutions, Chicago, IL.

6. "Product Information. Efudex (fluorouracil topical)." Valeant Pharmaceuticals, Costa Mesa, CA.

Some side effects of Efudex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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