fluorouracil topical

Name: fluorouracil topical — FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Reviewed byPlainmeds Editorial, Drug Information Editorial Team · June 5, 2026

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Brand names: Efudex

Topical Antimetabolite Rx

Fluorouracil topical (Efudex) is a skin cream that treats certain skin conditions. It belongs to a class of drugs called topical antimetabolites.

Drug Pricing (NADAC)

Brand Price

$1.44/unit

Generic Price

$2.99/unit

Generic Available

Yes (19 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

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What it does

This medicine treats skin growths called actinic or solar keratoses.

Common side effects

Redness, Burning, Itching

Key warnings

The treated skin can become very red, swollen, and uncomfortable.

How It Works

Fluorouracil stops cells from growing. It mainly affects fast-growing cells like those in skin growths or cancers. This helps to remove the abnormal skin cells.

How to Take It

Apply the cream to the affected skin areas as directed by your doctor. Usually, you will apply it 1-2 times a day. Use enough cream to cover the area completely. Wash your hands right after using the cream.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. This medicine may harm an unborn baby. It is not known if this medicine passes into breast milk.

Missed Dose

If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store the cream at room temperature, away from heat and moisture.

Serious Warnings

The treated skin can become very red, swollen, and uncomfortable. Tell your doctor if these symptoms become severe. This medicine can also make your skin more sensitive to the sun. Avoid sunlight or wear protective clothing and sunscreen.

Common Questions

Can I use a bandage over the treated area?

Ask your doctor if you should cover the area. Sometimes bandages can increase the medicine's effect.

How long will I need to use this medicine?

You will usually use this medicine for 2 to 4 weeks, but follow your doctor's instructions.

What should I do if I get the cream in my eyes?

Rinse your eyes with plenty of water and call your doctor.

Can I use other skin products on the treated area?

Talk to your doctor before using other skin products on the same area.

Is it normal for my skin to get very red?

Yes, some redness is normal. But tell your doctor if it becomes very painful or swollen.

What should I do if I accidentally swallow the cream?

Call a doctor or poison control center right away.

Can I go in the sun while using this medicine?

Try to avoid the sun as much as possible. Wear sunscreen and protective clothing if you must be outside.

How will I know if the medicine is working?

You may see the treated areas become red and irritated, then gradually heal.

What if I don't see improvement after several weeks?

Talk to your doctor if you don't see improvement after the recommended treatment time.

Can I use makeup on the treated area?

Ask your doctor if it is okay to use makeup on the treated area.

What are the common side effects of fluorouracil topical?

The most commonly reported side effects of fluorouracil topical include Redness, Burning, Itching, Pain, Swelling. Always consult your healthcare provider about potential side effects.

What drug class is fluorouracil topical?

fluorouracil topical belongs to the Topical Antimetabolite drug class. It requires a prescription (Rx). This medicine treats skin growths called actinic or solar keratoses.

Is fluorouracil topical safe during pregnancy?

Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. This medicine may harm an unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for fluorouracil topical

The FDA label for fluorouracil topical (sold under brand names such as Efudex) classifies it as a prescription-only medication in the Topical Antimetabolite class. This medicine treats skin growths called actinic or solar keratoses. Official labeling lists 6 commonly reported side effects, including Redness, Burning, Itching.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $2.99 versus $1.44 for the brand.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: April 23, 2025

Read our methodology — how this data is sourced, computed, and verified.

All federal data sources used on this page

FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages