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Fluorouracil topical Side Effects

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. 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:

More common:
  • Burning feeling where medicine is applied
  • increased sensitivity of skin to sunlight
  • itching
  • oozing
  • skin rash
  • soreness or tenderness of skin
Less common or rare:
  • 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]

References

1. "Product Information. Tolak (fluorouracil topical)." Hill Dermaceuticals Inc, Sanford, FL.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. "Product Information. Fluorouracil Topical (fluorouracil topical)." A-S Medication Solutions, Chicago, IL.

5. "Product Information. Efudex (fluorouracil topical)." Valeant Pharmaceuticals, Costa Mesa, CA.

6. "Product Information. Fluoroplex (fluorouracil topical)." Aqua Pharmaceuticals LLC, Malvern, PA.

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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