How Long Does Skin Burn After Using Efadux Cream

• Overview
• Consumer Data
• Professional Information

Fluorouracil Foam Side Effects Center

What Is Fluorouracil Cream?

Fluorouracil Cream, 0.5% (Microsphere) is an antineoplastic (anticancer) antimetabolite indicated for the topical handling of multiple actinic or solar keratoses of the face and inductive scalp. Fluorouracil cream is available in generic form.

What Are Side Effects of Fluorouracil Cream?

Common side effects of fluorouracil foam include:

• awarding site reactions (such equally redness, dryness, called-for, erosion [loss of the upper layer of peel], pain, irritation, and swelling),
• headache,
• common cold,
• allergy,
• upper respiratory infection,
• muscle soreness,
• sinus infection,
• dominicus sensitivity, and
• eye irritation.

The treated area may become unsightly during therapy.

Dosage for Fluorouracil Cream

Fluorouracil cream (microsphere) should be applied once a 24-hour interval to the skin where actinic keratosis lesions appear, using plenty to embrace the unabridged area with a thin picture show.

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

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

Fluorouracil Foam During Pregnancy and Breastfeeding

Fluorouracil cream is non recommended for use during pregnancy; information technology may harm a fetus. Information technology is unknown if fluorouracil foam passes into chest milk. Because of the potential for adverse effects on a nursing infant, breastfeeding is not recommended while using this drug.

Additional Data

Our Fluorouracil Cream, 0.five% (Microsphere) Side Effects Drug Heart provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a consummate listing of side effects and others may occur. Phone call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Fluorouracil Cream Consumer Information

Go emergency medical help if you lot take signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

• astringent pain or swelling of treated skin;
• severe itching, burning, or irritation;
• new or worsening pare sores;
• fever, chills; or
• astringent breadbasket pain, encarmine diarrhea, vomiting.

Earlier your peel 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 volition begin to shed off and you'll see raw skin appear. Ask your doctor when to stop using the medicine afterward you lot discover signs of healing.

Mutual side effects may include:

• skin hurting, itching, burning, or irritation;
• skin darkening or scarring;
• skin redness and swelling; or
• small blood vessels under the peel.

This is non a complete list of side furnishings and others may occur. Phone call your physician for medical advice about side effects. You lot may report side effects to FDA at 1-800-FDA-1088.

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

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Fluorouracil Cream Professional person Data

SIDE Furnishings

The following were adverse events considered to exist drug-related and occurring with a frequency of ≥ ane% with Fluorouracil Foam USP, 0.5% (Microsphere): awarding site reaction (94.half dozen%), and middle irritation (five.iv%). The signs and symptoms of facial irritation (awarding site reaction) are presented beneath.

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

Clinical Sign or Symptom	Active 1 Week Due north=85	Active Two Week Due north=87	Active Four Calendar week N=85	ALL Active Treatments N=257	Vehicle Treatments N=127
	northward (%)	n (%)	n (%)	due north (%)	n (%)
Erythema	76 (89.4)	82 (94.3)	82 (96.5)	240 (93.4)	76 (59.eight)
Dryness	59 (69.4)	76 (87.iv)	79 (92.9)	214 (83.3)	60 (47.ii)
Burning	51 (threescore.0)	70 (eighty.five)	71 (83.5)	192 (74.7)	28 (22.0)
Erosion	21 (24.7)	38 (43.7)	54 (63.5)	113 (44.0)	17 (13.four)
Pain	26 (xxx.6)	34 (39.1)	52 (61.two)	112 (43.half-dozen)	7 (5.v)
Edema	12 (14.1)	28 (32.2)	51 (threescore.0)	91 (35.4)	half dozen (four.7)

During clinical trials, irritation by and large began on day 4 and persisted for the remainder of treatment. Severity of facial irritation at the last handling visit was slightly beneath baseline for the vehicle group, balmy to moderate for the 1 week agile handling group, and moderate for the 2 and 4 week agile handling groups. Mean severity declined quickly for each active group after completion of handling and was below baseline for each group at the week 2 post-treatment follow-upwardly visit.

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

Eye irritation adverse events, described every bit balmy to moderate in intensity, were characterized every bit burning, watering, sensitivity, stinging and itching. These adverse events occurred beyond all handling arms in one of the two Phase 3 studies.

Summary of All Adverse Events Reported in ≥ 1% of Patients in the Combined Agile Treatment and Vehicle Groups - Pooled Phase 3 Studies
9721 and 9722 Combined

Adverse Outcome	Active One Calendar week Northward= 85 n(%)	Active Two Week N= 87 n(%)	Active Four Week N= 85 north(%)	ALL Active Treatments Due north=257 n(%)	Vehicle Treatments N=127 north(%)
BODY Every bit A WHOLE	7(8.2)	6(six.9)	12(xiv.i)	25(ix.7)	fifteen(11.8)
Headache	iii(iii.5)	2(2.3)	three(three.5)	8(three.1)	3(ii.4)
Common Cold	4(iv.7)	0	2(ii.4)	vi(two.3)	3(2.iv)
Allergy	0	2(2.3)	1(1.2)	iii(1.2)	2(1.6)
Infection Upper Respiratory	0	0	0	0	ii(1.vi)
MUSCULOSKELETAL	1(1.2)	1(1.1)	one(ane.2)	iii(i.ii)	5(3.9)
Muscle Soreness	0	0	0	0	ii(1.6)
RESPIRATORY	5(5.9)	0	1(1.2)	6(2.3)	6(4.7)
Sinusitis	4(4.7)	0	0	four(ane.6)	ii(1.6)
SKIN & APPENDAGES	78 (91.8)	83(95.4)	82(96.5)	243(94.six)	85(66.9)
Application Site Reaction	78 (91.8)	83(95.iv)	82(96.v)	243(94.6)	83(65.4)
Irritation Skin	1(1.ii)	0	2(two.4)	iii(1.2)	0
SPECIAL SENSES	6(7.one)	4(4.6)	vi(seven.one)	16(6.ii)	half dozen(4.7)
Eye Irritation	5(5.9)	3(3.4)	6(7.ane)	14 (v.four)	three(2.4)

Adverse Experiences Reported By Body System

In the Phase iii studies, no serious adverse event was considered related to study drug. A total of 5 patients, three in the agile treatment groups and two in the vehicle grouping, experienced at least i serious adverse issue. 3 patients died as a upshot of adverse upshot(s) considered unrelated to study drug (stomach cancer, myocardial infarction and cardiac failure).

Postal service-treatment clinical laboratory tests other than pregnancy tests were not performed during the Phase 3 clinical studies. Clinical laboratory tests were performed during comport of a Phase 2 study of 104 patients and 21 patients in a Stage one study. No aberrant serum chemistry, hematology, or urinalysis results in these studies were considered clinically significant.

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

© Fluorouracil Foam Patient Information is supplied by Cerner Multum, Inc. and Fluorouracil Cream Consumer information is supplied by Beginning Databank, Inc., used nether license and subject to their respective copyrights.

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