Tolak Side Effects
Generic Name: fluorouracil topical
Note: This page contains side effects data for the generic drug fluorouracil topical. It is possible that some of the dosage forms included below may not apply to the brand name Tolak.
For the Consumer
Applies to fluorouracil topical: topical cream, topical solution
As well as its needed effects, fluorouracil topical (the active ingredient contained in Tolak) may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking fluorouracil topical, check with your doctor immediately:
- Redness and swelling of normal skin
Minor Side Effects
Some fluorouracil topical side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:More common:
- Burning feeling where medicine is applied
- increased sensitivity of skin to sunlight
- skin rash
- soreness or tenderness of skin
- Darkening of skin
- watery eyes
For Healthcare Professionals
Applies to fluorouracil topical: topical cream, topical kit, topical solution
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.[Ref]
One case of life-threatening systemic toxicity was associated with fluorouracil topical (the active ingredient contained in Tolak) 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.[Ref]
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.[Ref]
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.[Ref]
Nervous system side effects have been reported infrequently and a causal relationship is remote. These included emotional upset, insomnia and irritability.[Ref]
Gastrointestinal side effects have been reported rarely and a causal relationship is remote. These include medicinal taste and stomatitis.[Ref]
Ocular side effects have been reported infrequently and a causal relationship is remote. These include conjunctival and corneal reactions, and lacrimation.[Ref]
Nasal irritation has been reported infrequently and a causal relationship is remote.[Ref]
Herpes simplex has been reported infrequently and a causal relationship is remote.[Ref]
1. "Product Information. Carac (fluorouracil topical)" Aventis Pharmaceuticals, Swiftwater, PA.
2. "Product Information. Efudex (fluorouracil topical)" ICN Pharmaceuticals, Costa Mesa, CA.
It is possible that some side effects of Tolak may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
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