What Is Carac Cream?
Carac Cream, 0.5% (fluorouracil) works by causing the death of cells that grow fastest, such as abnormal skin cells, and is used to treat scaly overgrowths of skin (actinic or solar keratoses). Carac Cream may also be used in the treatment of superficial basal cell carcinoma. Carac Cream is available in generic form.
What Are Side Effects of Carac Cream?
Common side effects of Carac Cream include:
- skin redness,
- irritation,
- dryness,
- scaling or peeling (exfoliation),
- burning,
- rash,
- pain,
- swelling, and
- other local reactions.
Serious side effects of Carac Cream are not likely to occur. Stop using of Carac Cream 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).
Dosage for Carac Cream
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.
What Drugs, Substances, or Supplements Interact with Carac Cream?
Carac Cream may interact with other prescription or over-the-counter skin products. Tell your doctor all medications and supplements you use.
Carac Cream During Pregnancy and Breastfeeding
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.
Additional Information
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.
QUESTION
Psoriasis causes the top layer of skin cells to become inflamed and grow too quickly and flake off. See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using fluorouracil topical and call your doctor at once if you have:
- severe pain or swelling of treated skin;
- severe itching, burning, or irritation;
- new or worsening skin sores;
- fever, chills; or
- severe stomach pain, bloody diarrhea, vomiting.
Before your skin begins to heal it will become red, dry, tender, and crusty. This is a normal skin reaction, even if these symptoms get worse for a short time. Gradually, the dead skin will begin to shed off and you'll see raw skin appear. Ask your doctor when to stop using the medicine after you notice signs of healing.
Common side effects may include:
- skin pain, itching, burning, or irritation;
- skin darkening or scarring;
- skin redness and swelling; or
- small blood vessels under the skin.
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.
SLIDESHOW
Types of Psoriasis: Medical Pictures and Treatments See SlideshowSIDE EFFECTS
The following were adverse events considered to be drug related and occurring with a frequency of ≥1% with Carac: application site reaction (94.6%), and eye irritation (5.4%). The signs and symptoms of facial irritation (i.e., application site reaction) are presented below.
Summary of Facial Irritation Signs and Symptoms - Pooled Phase 3 Studies
| Clinical Sign or Symptom | Active 1 Week N=85 |
Active 2 Week N=87 |
Active 4 Week N=85 |
ALL Active Treatments N=257 |
Vehicle Treatments 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 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 1 Week N= 85 |
Active 2 Week N= 87 |
Active 4 Week N= 85 |
ALL Active Treatments N=257 |
Vehicle Treatments 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.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321- 4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
No Information Provided
Read the entire FDA prescribing information for Carac (Fluorouracil)
© Carac Patient Information is supplied by Cerner Multum, Inc. and Carac Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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