Prescription medication · Topical Antimetabolite
fluorouracil topical
Also sold as Efudex. This medicine treats skin growths called actinic or solar keratoses.
Data updated 2026-05-15
- $1.44
- Brand price (NADAC)
fluorouracil topical (Efudex) is a prescription Topical Antimetabolite. This medicine treats skin growths called actinic or solar keratoses.
Fluorouracil topical (Efudex) is a skin cream that treats certain skin conditions. It belongs to a class of drugs called topical antimetabolites.
Verify with FDA → · CMS NADAC pricing →
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 →
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.
The sections below are summarized in plain English from fluorouracil topical's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
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?
How long will I need to use this medicine?
What should I do if I get the cream in my eyes?
Can I use other skin products on the treated area?
Is it normal for my skin to get very red?
What should I do if I accidentally swallow the cream?
Can I go in the sun while using this medicine?
How will I know if the medicine is working?
What if I don't see improvement after several weeks?
Can I use makeup on the treated area?
What are the common side effects of fluorouracil topical?
What drug class is fluorouracil topical?
What pregnancy or breastfeeding source fields are listed for fluorouracil topical?
Related Medications in Topical Antimetabolite
Other drugs grouped near fluorouracil topical - same-class peers and common alternatives.
adapalene
Differin
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apremilast
Otezla
Apremilast (Otezla/Otezla XR) is a medicine that can help adults and children manage psoriatic arthritis and psoriasis.
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azelaic acid
Finacea, Azelex
Azelaic acid gel is a topical medicine that helps treat rosacea.
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benzoyl peroxide
Benzac, PanOxyl
Benzoyl peroxide is a topical medicine that fights germs on your skin.
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betamethasone
Diprosone, Luxiq
Betamethasone dipropionate cream is a strong steroid medicine used on the skin.
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Medication Guides
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FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: April 23, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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