Carac Side Effects
Please note - some side effects for Carac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Carac - for the Consumer
Carac Cream
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Carac Cream:
Seek medical attention right away if any of these SEVERE side effects occur when using Carac Cream:Burning, crusting, redness, pain, soreness, inflammation, or irritation of the skin.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; change in skin color; chills; fever; scarring or sores on the treated area; severe or persistent burning, crusting, redness, pain, soreness, inflammation, or irritation of the skin; severe stomach pain; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopCarac Side Effects - for the Professional
Carac
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 (application site reaction) are presented below.
| Clinical Sign or Symptom | Active One Week N=85 |
Active Two Week N=87 |
Active Four 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.
| 9721 and 9722 Combined | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event | Active One Week N= 85 |
Active Two Week N= 87 |
Active Four 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 | 0 | 0 | 0 | 0 | 2 | (1.6) | ||||
| Respiratory | ||||||||||
| 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.
TopSide Effects by Body System - for Healthcare Professionals
Dermatologic
Dermatologic side effects have been the most frequently reported and include local burning, crusting, allergic contact dermatitis, erosions, erythema, hyperpigmentation, irritation, pain, photosensitivity, pruritus, scarring, rash, soreness, and ulceration, and other local reactions.
The following side effects have been reported infrequently and a causal relationship is remote: alopecia, blistering, bullous pemphigoid, discomfort, ichthyosis, scaling, suppuration, swelling, telangiectasia, tenderness, urticaria, and skin rash.
Other
One case of life-threatening systemic toxicity was associated with fluorouracil topical 5% cream in a patient with dihydropyrimidine dehydrogenase enzyme deficiency. Signs and symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, chills, stomatitis, erythematous rash, neutropenia, thrombocytopenia, and inflammation of the esophagus, stomach and small intestine.
Other
Miscarriages and a birth defect (ventricular septal defect) have been reported when fluorouracil was applied to mucous membrane areas of pregnant women. A cleft lip and palate have been reported when fluorouracil was applied as recommended.
Hematologic
Hematologic side effects have included leukocytosis, which has been the most frequently reported hematologic side effect. Eosinophilia, thrombocytopenia, and toxic granulation have been reported infrequently and a causal relationship is remote.
Nervous system
Nervous system side effects have been reported infrequently and a causal relationship is remote. These included emotional upset, insomnia and irritability.
Gastrointestinal
Gastrointestinal side effects have been reported rarely and a causal relationship is remote. These include medicinal taste and stomatitis.
Ocular
Ocular side effects have been reported infrequently and a causal relationship is remote. These include conjunctival and corneal reactions, and lacrimation.
Other
Nasal irritation has been reported infrequently and a causal relationship is remote.
Other
Herpes simplex has been reported infrequently and a causal relationship is remote.
TopMore Carac resources
- Carac Prescribing Information (FDA)
- Carac Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Carac Concise Consumer Information (Cerner Multum)
- Carac Topical Advanced Consumer (Micromedex) - Includes Dosage Information
- Efudex Prescribing Information (FDA)
- Fluoroplex Prescribing Information (FDA)
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