Does Flourouracil Cause Norman Skin To Turn Red

Fluorouracil Cream Side Effects Center

What Is Fluorouracil Cream?

Fluorouracil Cream, 0.five% (Microsphere) is an antineoplastic (anticancer) antimetabolite indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp. Fluorouracil cream is available in generic course.

What Are Side Furnishings of Fluorouracil Cream?

Mutual side furnishings of fluorouracil cream include:

application site reactions (such as redness, dryness, called-for, erosion [loss of the upper layer of skin], pain, irritation, and swelling),
headache,
common cold,
allergy,
upper respiratory infection,
muscle soreness,
sinus infection,
sun sensitivity, and
center irritation.

The treated surface area may become unsightly during therapy.

Dosage for Fluorouracil Cream

Fluorouracil cream (microsphere) should be applied once a day to the pare where actinic keratosis lesions appear, using enough to cover the unabridged area with a thin film.

What Drugs, Substances, or Supplements Collaborate with Fluorouracil Foam?

Fluorouracil cream may interact with other drugs. Tell your doctor all medications and supplements you apply.

Fluorouracil Cream During Pregnancy and Breastfeeding

Fluorouracil cream is not recommended for use during pregnancy; it may harm a fetus. It is unknown if fluorouracil cream passes into chest milk. Because of the potential for agin effects on a nursing babe, breastfeeding is not recommended while using this drug.

Additional Information

Our Fluorouracil Cream, 0.five% (Microsphere) Side Furnishings Drug Center provides a comprehensive view of available drug data on the potential side furnishings when taking this medication.

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

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Fluorouracil Cream Consumer Information

Get emergency medical assistance if you have signs of an allergic reaction: hives; difficult animate; swelling of your face, lips, tongue, or throat.

Terminate using fluorouracil topical and call your doctor at once if you have:

astringent hurting or swelling of treated pare;
severe itching, called-for, or irritation;
new or worsening skin sores;
fever, chills; or
severe stomach hurting, encarmine diarrhea, vomiting.

Earlier your skin begins to heal it will become carmine, dry, tender, and crusty. This is a normal skin reaction, even if these symptoms become worse for a brusk time. Gradually, the dead skin will begin to shed off and yous'll see raw pare appear. Ask your md when to stop using the medicine afterwards y'all notice signs of healing.

Common side effects may include:

peel pain, itching, burning, or irritation;
skin darkening or scarring;
pare redness and swelling; or
minor blood vessels under the skin.

This is not a complete list of side furnishings and others may occur. Phone call your doctor for medical communication nigh side furnishings. You lot may written report side effects to FDA at ane-800-FDA-1088.

Read the entire detailed patient monograph for Fluorouracil Cream (Fluorouracil Cream)

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Fluorouracil Cream Professional Information

SIDE Furnishings

The post-obit were agin events considered to exist drug-related and occurring with a frequency of ≥ 1% with Fluorouracil Cream USP, 0.5% (Microsphere): application site reaction (94.vi%), and heart irritation (five.4%). The signs and symptoms of facial irritation (application site reaction) are presented below.

Summary of Facial Irritation Signs and Symptoms - Pooled Stage three Studies

Clinical Sign or Symptom	Agile One Week N=85	Active Two Week N=87	Active Iv Week Northward=85	ALL Active Treatments Northward=257	Vehicle Treatments Northward=127
Clinical Sign or Symptom	n (%)	n (%)	n (%)	n (%)	n (%)
Erythema	76 (89.4)	82 (94.3)	82 (96.v)	240 (93.4)	76 (59.viii)
Dryness	59 (69.4)	76 (87.four)	79 (92.9)	214 (83.three)	60 (47.2)
Called-for	51 (lx.0)	70 (fourscore.5)	71 (83.5)	192 (74.7)	28 (22.0)
Erosion	21 (24.vii)	38 (43.7)	54 (63.5)	113 (44.0)	17 (13.4)
Hurting	26 (30.vi)	34 (39.1)	52 (61.2)	112 (43.vi)	vii (5.five)
Edema	12 (14.one)	28 (32.ii)	51 (threescore.0)	91 (35.4)	6 (4.7)

During clinical trials, irritation generally began on day 4 and persisted for the residual of treatment. Severity of facial irritation at the last handling visit was slightly below baseline for the vehicle group, balmy to moderate for the 1 calendar week agile treatment group, and moderate for the 2 and 4 week active treatment groups. Hateful severity declined quickly for each active grouping later on completion of treatment and was below baseline for each group at the calendar week 2 post-treatment follow-up visit.

Thirty-i patients (12% of those treated with Fluorouracil Cream USP, 0.5% (Microsphere) in the Phase 3 clinical studies) discontinued report treatment early due to facial irritation. Except for three patients, discontinuation of treatment occurred on or after day 11 of treatment.

Eye irritation agin events, described equally mild to moderate in intensity, were characterized as called-for, watering, sensitivity, stinging and itching. These adverse events occurred beyond all treatment arms in i of the 2 Phase 3 studies.

Summary of All Adverse Events Reported in ≥ one% of Patients in the Combined Active Treatment and Vehicle Groups - Pooled Phase 3 Studies
9721 and 9722 Combined

Adverse Consequence	Agile One Week N= 85 northward(%)	Active Two Week N= 87 n(%)	Active Four Week N= 85 n(%)	ALL Active Treatments N=257 n(%)	Vehicle Treatments North=127 northward(%)
Body As A WHOLE	7(8.ii)	half-dozen(half-dozen.ix)	12(14.ane)	25(ix.7)	15(11.8)
Headache	iii(3.5)	2(2.3)	three(3.5)	8(3.1)	3(2.4)
Common Cold	four(iv.7)	0	2(2.4)	6(ii.3)	three(ii.iv)
Allergy	0	2(2.3)	1(1.two)	3(ane.2)	two(ane.6)
Infection Upper Respiratory	0	0	0	0	two(one.6)
MUSCULOSKELETAL	1(1.2)	1(1.1)	1(1.2)	3(1.2)	5(iii.9)
Muscle Soreness	0	0	0	0	2(1.half-dozen)
RESPIRATORY	5(v.9)	0	1(1.2)	6(two.3)	6(4.vii)
Sinusitis	4(4.7)	0	0	four(one.half-dozen)	two(ane.6)
SKIN & APPENDAGES	78 (91.8)	83(95.4)	82(96.5)	243(94.six)	85(66.9)
Application Site Reaction	78 (91.eight)	83(95.four)	82(96.five)	243(94.6)	83(65.4)
Irritation Pare	one(1.two)	0	two(2.four)	iii(one.2)	0
SPECIAL SENSES	vi(vii.i)	4(four.half dozen)	6(7.1)	16(vi.2)	6(iv.7)
Middle Irritation	5(five.ix)	3(three.iv)	6(seven.1)	xiv (5.four)	three(2.4)

Agin Experiences Reported By Body Arrangement

In the Stage 3 studies, no serious agin result was considered related to study drug. A total of five patients, three in the active handling groups and ii in the vehicle group, experienced at least one serious adverse event. Iii patients died as a event of agin event(due south) considered unrelated to study drug (tummy cancer, myocardial infarction and cardiac failure).

Post-treatment clinical laboratory tests other than pregnancy tests were non performed during the Stage 3 clinical studies. Clinical laboratory tests were performed during deport of a Phase 2 study of 104 patients and 21 patients in a Phase one study. No abnormal serum chemical science, hematology, or urinalysis results in these studies were considered clinically significant.

Read the entire FDA prescribing information for Fluorouracil Cream (Fluorouracil Foam)

© Fluorouracil Cream Patient Data is supplied by Cerner Multum, Inc. and Fluorouracil Cream Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.