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.

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.

For the Consumer

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

Serious side effects are not likely to occur. Stop using fluorouracil topical (the active ingredient contained in Efudex) 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.

For Healthcare Professionals

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

Dermatologic

Dermatologic side effects have been the most frequently reported and include local burning, crusting, allergic contact dermatitis, erosions, erythema, hyperpigmentation, irritation, pain, photosensitivity, pruritus, scarring, rash, soreness, and ulceration, and other local reactions.

The following side effects have been reported infrequently and a causal relationship is remote: alopecia, blistering, bullous pemphigoid, discomfort, ichthyosis, scaling, suppuration, swelling, telangiectasia, tenderness, urticaria, and skin rash.

Other

One case of life-threatening systemic toxicity was associated with fluorouracil topical (the active ingredient contained in Efudex) 5% cream in a patient with dihydropyrimidine dehydrogenase enzyme deficiency. Signs and symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, chills, stomatitis, erythematous rash, neutropenia, thrombocytopenia, and inflammation of the esophagus, stomach and small intestine.

Miscarriages and a birth defect (ventricular septal defect) have been reported when fluorouracil was applied to mucous membrane areas of pregnant women. A cleft lip and palate have been reported when fluorouracil was applied as recommended.

Hematologic

Hematologic side effects have included leukocytosis, which has been the most frequently reported hematologic side effect. Eosinophilia, thrombocytopenia, and toxic granulation have been reported infrequently and a causal relationship is remote.

Nervous system

Nervous system side effects have been reported infrequently and a causal relationship is remote. These included emotional upset, insomnia and irritability.

Gastrointestinal

Gastrointestinal side effects have been reported rarely and a causal relationship is remote. These include medicinal taste and stomatitis.

Ocular

Ocular side effects have been reported infrequently and a causal relationship is remote. These include conjunctival and corneal reactions, and lacrimation.

Other

Nasal irritation has been reported infrequently and a causal relationship is remote.

Herpes simplex has been reported infrequently and a causal relationship is remote.

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