Carac

Carac Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Carac Cream, 0.5% (fluorouracil) is used to treat scaly overgrowths of skin (actinic or solar keratoses). It may also be used in the treatment of superficial basal cell carcinoma. It works by causing the death of cells that grow fastest, such as abnormal skin cells. This medication is available in generic form. Common side effects include skin irritation, dryness, scaling or peeling (exfoliation), rash, and other local reactions.

Carac Cream should be applied in a once a day dose to the skin where actinic keratosis lesions appear, using enough to cover the entire area with a thin film. Use for up to 4 weeks, as tolerated. Carac Cream may interact with other prescription or over-the-counter skin products. Tell your doctor all medications and supplements you use. Carac Cream topical must not be used if you are pregnant or planning a pregnancy. It is known to harm a fetus. Miscarriage and birth defects have been reported. Discuss birth control with your doctor before starting treatment with Carac. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Carac Cream, 0.5% (fluorouracil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Carac in Detail - Patient Information: Side Effects

Serious side effects are not likely to occur. Stop using fluorouracil topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Fluorouracil topical may cause skin irritation, dryness, scaling or peeling (exfoliation), rash, and other local reactions. Eye irritation has also been reported. If these side effects are excessive or worsen with continued treatment, contact your doctor.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Carac (Fluorouracil) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Carac FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following were adverse events considered to be drug-related and occurring with a frequency of ≥ 1% with Carac (fluorouracil) : application site reaction (94.6%), and eye irritation (5.4%). The signs and symptoms of facial irritation (application site reaction) are presented below.

Summary of Facial Irritation Signs and Symptoms - Pooled Phase 3 Studies

Clinical Sign or
Symptom
Active One
Week
Active Two
Week
Active Four
Week
ALL Active
Treatments
Vehicle
Treatments
N=85 N=87 N=85 N=257 N=127
n (%) n (%) n (%) n (%) n (%)
Erythema 76 (89.4) 82 (94.3) 82 (96.5) 240 (93.4) 76 (59.8)
Dryness 59 (69.4) 76 (87.4) 79 (92.9) 214 (83.3) 60 (47.2)
Burning 51 (60.0) 70 (80.5) 71 (83.5) 192 (74.7) 28 (22.0)
Erosion 21 (24.7) 38 (43.7) 54 (63.5) 113 (44.0) 17 (13.4)
Pain 26 (30.6) 34 (39.1) 52 (61.2) 112 (43.6) 7 (5.5)
Edema 12 (14.1) 28 (32.2) 51 (60.0) 91 (35.4) 6 (4.7)

During clinical trials, irritation generally began on day 4 and persisted for the remainder of treatment. Severity of facial irritation at the last treatment visit was slightly below baseline for the vehicle group, mild to moderate for the 1 week active treatment group, and moderate for the 2 and 4 week active treatment groups. Mean severity declined rapidly for each active group after completion of treatment and was below baseline for each group at the week 2 post-treatment follow-up visit.

Thirty-one patients (12% of those treated with Carac (fluorouracil) in the Phase 3 clinical studies) discontinued study treatment early due to facial irritation. Except for three patients, discontinuation of treatment occurred on or after day 11 of treatment.

Eye irritation adverse events, described as mild to moderate in intensity, were characterized as burning, watering, sensitivity, stinging and itching. These adverse events occurred across all treatment arms in one of the two Phase 3 studies.

Summary of All Adverse Events Reported in ≥ 1% of Patients in the Combined Active Treatment and Vehicle Groups - Pooled Phase 3 Studies

9721 and 9722 Combined
Adverse Event Active One
Week
Active Two
Week
Active Four
Week
ALL Active
Treatments
Vehicle
Treatments
N=85 N=87 N=85 N=257 N=127
n (%) n (%) n (%) n (%) n (%)
BODY AS A WHOLE 7 (8.2) 6 (6.9) 12 (14.1) 25 (9.7) 15 (11.8)
Headache 3 (3.5) 2 (2.3) 3 (3.5) 8 (3.1) 3 (2.4)
Common Cold 4 (4.7) 0 2 (2.4) 6 (2.3) 3 (2.4)
Allergy 0 2 (2.3) 1 (1.2) 3 (1.2) 2 (1.6)
Infection Upper Respiratory 0 0 0 0 2 (1.6)
MUSCULOSKELETAL 1 (1.2) 1 (1.1) 1 (1.2) 3 (1.2) 5 (3.9)
Muscle Soreness 0 0 0 0 2 (1.6)
RESPIRATORY 5 (5.9) 0 1 (1.2) 6 (2.3) 6 (4.7)
Sinusitis 4 (4.7) 0 0 4 (1.6) 2 (1.6)
SKIN & APPENDAGES 78 (91.8) 83 (95.4) 82 (96.5) 243 (94.6) 85 (66.9)
Application Site 78 (91.8) 83 (95.4) 82 (96.5) 243 (94.6) 83 (65.4)
Reaction                    
Irritation Skin 1 (1.2) 0 2 (2.4) 3 (1.2) 0
SPECIAL SENSES 6 (7.1) 4 (4.6) 6 (7.1) 16 (6.2) 6 (4.7)
Eye Irritation 5 (5.9) 3 (3.4) 6 (7.1) 14 (5.4) 3 (2.4)

Adverse Experiences Reported by Body System

In the Phase 3 studies, no serious adverse event was considered related to study drug. A total of five patients, three in the active treatment groups and two in the vehicle group, experienced at least one serious adverse event. Three patients died as a result of adverse event(s) considered unrelated to study drug (stomach cancer, myocardial infarction and cardiac failure).

Post-treatment clinical laboratory tests other than pregnancy tests were not performed during the Phase 3 clinical studies. Clinical laboratory tests were performed during conduct of a Phase 2 study of 104 patients and 21 patients in a Phase 1 study. No abnormal serum chemistry, hematology, or urinalysis results in these studies were considered clinically significant.

Read the entire FDA prescribing information for Carac (Fluorouracil) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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