Efudex Side Effects
Generic Name: fluorouracil topical
Note: This page contains information about the side effects of fluorouracil topical. Some of the dosage forms included on this document may not apply to the brand name Efudex.
Not all side effects for Efudex may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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
- skin rash
- soreness or tenderness of skin
- Darkening of skin
- watery eyes
For Healthcare Professionals
Applies to fluorouracil topical: topical cream, topical kit, topical solution
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.
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 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 side effects have been reported infrequently and a causal relationship is remote. These included emotional upset, insomnia and irritability.
Gastrointestinal side effects have been reported rarely and a causal relationship is remote. These include medicinal taste and stomatitis.
Ocular side effects have been reported infrequently and a causal relationship is remote. These include conjunctival and corneal reactions, and lacrimation.
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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