Efudex Topical Cream 5pct Drug Medication Dosage Information
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Efudex: Topical cream (5%)

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What is this Medicine?

FLUOROURACIL, 5-FU (flure oh YOOR a sil) is a chemotherapy agent. It is used on the skin to treat skin cancer and skin conditions that could become cancer.

In-Depth Information

Efudex 5% Topical Cream

NDC: 001873204
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Breast Cancer, Basal Cell Carcinoma, Colorectal Cancer, Gastric Cancer, Actinic Keratosis

Storage Information
Store at 77 degrees F; excursions permitted to 59-86 degrees F
Efudex 5% Topical Cream

Reported Side Effects for Efudex 5% Topical Cream

Skin Irritation Incidence:
<2.4%*
Severity: MILD
Onset: EARLY
Headache Incidence:
<3.1%*
Severity: MILD
Onset: EARLY
Itchy Eyes Incidence:
<5.4%*
Severity: MILD
Onset: RAPID
Sinus Infection Incidence:
<4.7%*
Severity: MILD
Onset: DELAYED
Infection Incidence:
<4.7%*
Severity: MILD
Onset: DELAYED
Secretion Of Tears Incidence:
3.4-5.9%*
Severity: MILD
Onset: EARLY
Eye Irritation Incidence:
3.4-5.9%*
Severity: MILD
Onset: RAPID
Eye Pain Incidence:
3.4-5.9%*
Severity: MILD
Onset: EARLY
Mouth Ulcers Incidence:
>10.0%*
Severity: MODERATE
Onset: DELAYED
Swelling Incidence:
14.1-69.0%*
Severity: MODERATE
Onset: DELAYED
Skin Ulcer Incidence:
24.7-68.0%*
Severity: MODERATE
Onset: DELAYED
Dry Skin Incidence:
69.0-95.0%*
Severity: MILD
Onset: DELAYED
Itching Incidence:
85.0%*
Severity: MILD
Onset: RAPID
Skin Redness Incidence:
89.4-99.0%*
Severity: MODERATE
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

SECOND Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

THIRD Trimester

Class X - Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


Learning More About
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