Efudex Occlusion Pack 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 Occlusion Pack.

For the Consumer

Applies to fluorouracil topical: topical cream, topical solution

In addition to its needed effects, some unwanted effects may be caused by fluorouracil topical (the active ingredient contained in Efudex Occlusion Pack). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking fluorouracil topical:

• Redness and swelling of normal skin

Minor Side Effects

Some of the side effects that can occur with fluorouracil topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• Burning feeling where medicine is applied
• increased sensitivity of skin to sunlight
• itching
• oozing
• skin rash
• soreness or tenderness of skin

• Darkening of skin
• scaling
• watery eyes

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.^[Ref]

Other

One case of life-threatening systemic toxicity was associated with fluorouracil topical (the active ingredient contained in Efudex Occlusion Pack) 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.^[Ref]

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.^[Ref]

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.^[Ref]

Nervous system

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

Gastrointestinal

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

Ocular

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

Other

Nasal irritation has been reported infrequently and a causal relationship is remote.^[Ref]

Herpes simplex has been reported infrequently and a causal relationship is remote.^[Ref]

Not all side effects for Efudex Occlusion Pack may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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