Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The most frequent adverse reactions to Fluorouracil Cream occur locally and are often related to an extension of the pharmacological activity of the drug.
These include burning, crusting, allergic contact dermatitis, pruritus, scarring, rash, soreness, and ulceration.
Ulcerations, other local reactions, cases of miscarriage, and a birth defect (ventricular septal defect) have been reported when Fluorouracil Cream was applied to mucous membrane areas.
Leukocytosis is the most frequent hematological side effect.
Although a causal relationship is remote, other adverse reactions which have been reported infrequently are: Central Nervous System: Emotional upset, insomnia, irritability.
Gastrointestinal: Medicinal taste, stomatitis.
Hematological: Eosinophilia, thrombocytopenia, toxic granulation.
Integumentary: Alopecia, blistering, bullous pemphigoid, discomfort, ichthyosis, scaling, suppuration, swelling, telangiectasia, tenderness, urticaria, skin rash.
Special Senses: Conjunctival reaction, corneal reaction, lacrimation, nasal irritation.
Miscellaneous: Herpes simplex.
WARNINGS Application to mucous membranes should be avoided due to the possibility of local inflammation and ulceration.
Additionally, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when Fluorouracil Cream was applied to mucous membrane areas during pregnancy.
Occlusion of the skin with resultant hydration has been shown to increase percutaneous penetration of several topical preparations.
If any occlusive dressing is used in treatment of basal cell carcinoma, there may be an increase in the severity of inflammatory reactions in the adjacent normal skin.
A porous gauze dressing may be applied for cosmetic reasons without increase in reaction.
Like all medications, Fluorouracil can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: