Efudex Occlusion Pack 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 Occlusion Pack.

For the Consumer

Applies to fluorouracil topical: topical cream, topical solution

Along with its needed effects, fluorouracil topical (the active ingredient contained in Efudex Occlusion Pack) 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:

• 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

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]

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.

Medical Disclaimer