Fluoroplex Side Effects

Please note - some side effects for Fluoroplex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Fluoroplex - for the Consumer

Fluoroplex Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fluoroplex Cream:

Burning, crusting, redness, pain, soreness, inflammation, or irritation of the skin.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; change in skin color; chills; fever; scarring or sores on the treated area; severe or persistent burning, crusting, redness, pain, soreness, inflammation, or irritation of the skin; severe stomach pain; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Fluoroplex Side Effects - for the Professional

Fluoroplex

Pain, pruritus, burning, irritation, inflammation, allergic contact dermatitis and telangiectasia have been reported. Occasionally, hyperpigmentation and scarring have also been reported.

Side Effects by Body System - for Healthcare Professionals

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.

Other

One case of life-threatening systemic toxicity was associated with fluorouracil topical 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.

Other

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.

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.

Nervous system

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

Gastrointestinal

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

Ocular

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

Other

Nasal irritation has been reported infrequently and a causal relationship is remote.

Other

Herpes simplex has been reported infrequently and a causal relationship is remote.

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