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

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]

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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