Carac® Safety

What are the possible side effects of Carac®?

Most patients using Carac® get skin reactions. These reactions include redness, dryness, burning, pain, erosion (loss of the upper layer of skin), and swelling. Irritation may continue for 2 or more weeks after treatment is over. The treated area may become unsightly during therapy.

Some patients get eye irritation. Eye irritation might consist of burning, sensitivity, itching, stinging, and watering. Remember to avoid contact with you eyes. If you are concerned about side effects, talk to your doctor.

Some patients have reported side effects such as stomach pain, diarrhea, vomiting, fever, or chills, possibly due to the lack of a specific enzyme, dihydropyrimidine dehydrogenase (DPD), in their body. If you experience any of these symptoms, discontinue therapy immediately and contact your doctor. Be sure to tell your doctor if you have DPD enzyme deficiency.

What should I avoid while using Carac®?

• Avoid sunlight or other ultraviolet light (such as tanning booths) while using Carac®. Sunlight may increase your side effects. When exposed to sunlight, wear a hat and use sunscreen.
• Do not cover the treated skin with a dressing.
• Do not breast feed or become pregnant while using Carac®. If you do become pregnant, stop using Carac® and tell your doctor right away.

Who should not use Carac®?

Do not use Carac®:

• if you are pregnant or might become pregnant. Carac® may harm your unborn child.
• if you are nursing a baby. We do not know if Carac® can pass to the baby through the milk.
• if you have DPD enzyme deficiency. The active ingredient in Carac®, 5-fluorouracil 0.5%, can cause serious side effects in patients who are DPD enzyme deficient. If you have DPD enzyme deficiency and use medications containing fluorouracil, you may develop serious side effects such as stomach pain, bloody diarrhea, vomiting, fever, or chills.
• if you are allergic to the ingredients in Carac®. Ask your doctor or pharmacist about the inactive ingredients.
• if you are under 18 years of age. Carac® should not be used in children.

Tell your doctor if you are able to become pregnant. Your doctor may advise you about birth control to avoid pregnancy.