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The following safety information outlines critical warnings and precautions associated with the use of this medication. It is important to understand these risks and consult with your healthcare provider if you have any concerns or questions.

• Application Caution: Do not apply fluorouracil (Efudex) topical to sensitive skin areas or near mucous membranes, including the eyes, mouth, or nose, as this may increase the risk of skin damage.

• Avoid Covering Treated Areas: Refrain from using bandages or dressings over areas where fluorouracil (Efudex) topical has been applied, as this can enhance medication absorption and lead to additional skin-related side effects.

• Sun Exposure: Exposure to ultraviolet (UV) light can result in serious skin reactions such as painful peeling or blistering. Avoid using sun lamps and tanning beds during and after treatment. Limit sun exposure, and consult your dermatologist about appropriate sunscreen and protective clothing, like hats and long sleeves.

• Pregnancy Warning: Fluorouracil (Efudex) topical may cause harm to an unborn child, including birth defects and miscarriage, if used during pregnancy. If you are pregnant or planning to become pregnant, inform your dermatologist. This is particularly important for females of childbearing age.

• Rare Toxicity Reaction: There is a rare but serious risk of toxicity reported in individuals using fluorouracil 5% topical cream, especially those with dihydropyrimidine dehydrogenase (DPD) deficiency. Symptoms may include stomach pain, bloody diarrhea, vomiting, fever, and inflammation or sores in the mouth, stomach, and intestines.

Contraindications:

• This medication should not be used if you are currently pregnant or have dihydropyrimidine dehydrogenase (DPD) deficiency, as it may pose serious health risks. Consult your healthcare provider if these conditions apply to you.

Common side effects:

• Crusting
• Stinging or burning sensation
• Itchiness
• Soreness
• Scarring on the skin

Less common but important to monitor:

• Darkening of the skin color
• Skin tenderness
• Open sores
• Rash
• Swelling
• Blistering

Serious side effects:

• Stomach pains
• Bloody diarrhea
• Vomiting
• Fever
• Chills
• Skin rash
• Painful mouth sores

5-Fluorouracil (5-FU) is a chemotherapy medication used to treat various cancers. It's important to be aware of potential interactions between 5-FU and other medications, as these can affect treatment effectiveness and safety.

Anticoagulants (Blood Thinners): Combining 5-FU with anticoagulants like Warfarin can increase the risk of bleeding. This occurs because 5-FU may enhance the blood-thinning effects of these medications. Patients using both should have their blood clotting times monitored closely to adjust dosages as needed.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Using NSAIDs such as Aspirin, Ibuprofen, or Naproxen alongside 5-FU can raise the risk of bleeding. This is due to the combined effects of both drugs on blood platelets, which are essential for clotting. Caution is advised when these medications are used together.

Phenytoin: 5-FU can increase blood levels of phenytoin, a medication used to control seizures. Elevated phenytoin levels may lead to toxicity, so monitoring phenytoin concentrations is recommended when used with 5-FU.

Leucovorin (Folinic Acid): Leucovorin is sometimes administered with 5-FU to enhance its cancer-fighting effects. However, this combination can also intensify side effects like mouth sores and diarrhea. Patients should be monitored for these adverse effects during treatment.

Metronidazole: Combining metronidazole, an antibiotic, with 5-FU may increase the risk of severe side effects, including neurotoxicity, which can affect the nervous system. Careful monitoring is necessary if these drugs are used together.

Allopurinol: Allopurinol, used to treat gout, may reduce the effectiveness of 5-FU. Patients should inform their healthcare provider if they are taking allopurinol to assess the need for dosage adjustments.

Live Vaccines: Patients undergoing 5-FU treatment should avoid live vaccines, as the chemotherapy can weaken the immune system, increasing the risk of infection from the vaccine.

It's crucial to inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting 5-FU therapy. This ensures that potential interactions are identified and managed appropriately to maintain the safety and effectiveness of your treatment.