Efudex Occlusion Pack Side Effects
Generic name: fluorouracil topical
Medically reviewed by Drugs.com. Last updated on Dec 4, 2022.
Note: This document contains side effect information about fluorouracil topical. Some dosage forms listed on this page may not apply to the brand name Efudex Occlusion Pack.
Applies to fluorouracil topical: topical cream, topical solution.
Serious side effects
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:
Incidence not known
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- chest pain
- painful or difficult urination
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Other side effects
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:
Incidence not known
- Dry, rough, or scaly skin
- loss or thinning of the hair
- raised, dark red, wart-like spots on the skin, especially when used on the face
- swelling or inflammation of the mouth
- tearing of the eyes
- trouble sleeping
For Healthcare Professionals
Applies to fluorouracil topical: topical cream, topical kit, topical solution.
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]
Very rare (less than 0.01%): Diarrhea, vomiting, abdominal pain, stomatitis, mucosal inflammation
Frequency not reported: Nausea, medicinal taste[Ref]
Frequency not reported: Leukocytosis, eosinophilia, thrombocytopenia, toxic granulation[Ref]
Very rare (less than 0.01%): Hypersensitivity[Ref]
Frequency not reported: Dysgeusia, headache, dizziness[Ref]
Frequency not reported: Conjunctival irritation, corneal reaction, keratitis, increased lacrimation[Ref]
Very rare (less than 0.01%): Pyrexia, chills[Ref]
Frequency not reported: Nasal irritation[Ref]
Frequency not reported: Emotional upset, irritability, insomnia[Ref]
More about Efudex Occlusion Pack (fluorouracil topical)
- Compare alternatives
- Dosage information
- During pregnancy
- Drug class: topical antineoplastics
Related treatment guides
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. "Product Information. Fluorouracil Topical (fluorouracil topical)." A-S Medication Solutions (2017):
4. "Product Information. Tolak (fluorouracil topical)." Hill Dermaceuticals Inc (2017):
5. "Product Information. Efudex (fluorouracil topical)." Valeant Pharmaceuticals (2017):
6. "Product Information. Fluoroplex (fluorouracil topical)." Aqua Pharmaceuticals LLC (2017):
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.