Bausch Health / Efudex
FLUOROURACIL CREAM 5% / SOLUTION 2% AND 5%
The incumbent R-54 is competing with: a chemotherapy agent applied to the face for two to four weeks, stopped when the skin reaches the erosion stage, unsightly for weeks afterwards, and around $36. Its label contains no efficacy figure of any kind.
Worth buying for a specific person with a specific problem. Read who.
ASSESSED ON 75% OF THE MODEL. 2 CRITERIA LEFT UNSCORED — SEE SCORING FOR WHY.
We earn nothing on this link. Ask what the erosion stage looks like and how long you should expect to look unwell — the label says several weeks after you stop, and that is the part people are unprepared for.
The verdict
Efudex is what field treatment for actinic keratosis looked like before Klisyri, and it is still in wide use because it works and costs almost nothing. Fluorouracil is a cytotoxic antimetabolite — a chemotherapy drug — applied topically so that it destroys the rapidly dividing atypical cells in a field of sun-damaged skin. A 40 g tube runs about $36 with a discount card.
The dosing instruction is unlike anything else in this register. You do not apply it for a fixed course. You apply it twice daily and continue 'until the inflammatory response reaches the erosion stage, at which time use of the drug should be terminated' — the endpoint is a tissue reaction you observe rather than a date. The usual duration is two to four weeks, and complete healing may not be evident for one to two months after you stop.
The label carries no efficacy data whatsoever. There is no clinical studies section, no success rate, no comparator arm, no sample size. That is an artefact of when this product was approved rather than a sign the drug does not work — fluorouracil for actinic keratosis has decades of literature and guideline support behind it. But it means the label itself cannot tell a patient what to expect, which is precisely what R-54's label does in a table.
The contraindications are serious and specific. It is contraindicated in pregnancy and in women who may become pregnant during therapy, with birth defects reported in patients using it as directed. It is contraindicated in dihydropyrimidine dehydrogenase deficiency, where one case of life-threatening systemic toxicity has been reported from the topical cream. And the label warns that it may be fatal if ingested by pets — a specific, practical warning that nothing else here contains.
- Around $36 for a complete course — the cheapest effective treatment in this register.
- A treatment that ends, with a stopping rule based on an observable tissue endpoint.
- States the pregnancy contraindication and names the specific birth defects reported.
- Contraindicated in DPD deficiency, with the life-threatening topical case described in full.
- Warns that the reaction will be unsightly during therapy and for several weeks after stopping.
- Warns that it may be fatal if ingested by pets, and how to avoid residue on hands, clothing and furniture.
- Instructs biopsy of lesions that do not respond, and follow-up biopsy for superficial basal cell carcinoma.
- Full excipient lists for both the cream and the solution, with published fills.
- Two solution strengths and two dispenser sizes alongside the cream.
- Generic fluorouracil is widely available at the same strength.
- No efficacy figure of any kind on the label — no trial, no success rate, no comparator.
- Adverse reactions are an unquantified list, with no rates and no vehicle arm.
- Two to four weeks of treatment, then one to two months before healing is complete.
- The therapeutic endpoint is erosion, which is disfiguring while it lasts.
- Contraindicated in pregnancy, and in women who may become pregnant during therapy.
- Contraindicated in DPD deficiency, which most people have never been tested for.
- Occlusion increases penetration and the severity of the reaction in adjacent normal skin.
- Ultraviolet exposure intensifies the reaction, during and immediately after treatment.
- Safety and effectiveness in children have not been established.
- It is a cytotoxic drug being handled at home, with real risks to pets and to anything it is left on.
Every active, assessed
- Fluorouracil5% cream · 2% and 5% solution
Cytotoxic antimetabolite — blocks thymidylate synthase, destroying rapidly dividing atypical keratinocytes across a treated field
- BENCHMARK
- 5% is the standard topical strength for actinic keratosis
- ASSESSMENT
- A chemotherapy agent used topically, and the only one in this register. Its effect is not modulation of a pathway — it is destruction of a cell population, which is why the treatment endpoint is visible erosion and why the recovery takes longer than the treatment. Correctly dosed, cheap, and demanding of the patient in a way nothing else here is.
| ACTIVE | CONC. | BENCHMARK | ASSESSMENT |
|---|---|---|---|
| FluorouracilCytotoxic antimetabolite — blocks thymidylate synthase, destroying rapidly dividing atypical keratinocytes across a treated field | 5% cream · 2% and 5% solution | 5% is the standard topical strength for actinic keratosis | A chemotherapy agent used topically, and the only one in this register. Its effect is not modulation of a pathway — it is destruction of a cell population, which is why the treatment endpoint is visible erosion and why the recovery takes longer than the treatment. Correctly dosed, cheap, and demanding of the patient in a way nothing else here is. |
Scoring
- EVIDENCE FOR THE ACTIVEWEIGHT 30%58/100
Fluorouracil for actinic keratosis is guideline-supported with decades of published trial literature, and none of it is on this label — no clinical studies section, no success rate, no comparator, no sample size. We score what a reader can check from the document in front of them, and the answer here is nothing. That is a scoring judgement about disclosure-in-evidence, not a claim that the drug is unproven.
- FORMULATION INTEGRITYWEIGHT 20%55/100
A plain vanishing cream at the standard strength with a full excipient list and a published 40 g fill, plus two solution strengths in two dispenser sizes. Nothing about the vehicle mitigates anything — which for a drug whose therapeutic endpoint is erosion is arguably correct, but it means the entire burden of the treatment falls on the patient. Marked down for parabens and propylene glycol on skin that will be eroded by design.
- DISCLOSUREWEIGHT 15%62/100
Excellent on risk and empty on benefit. It states the pregnancy contraindication with the specific birth defects reported, the DPD contraindication with the case history, that the reaction will be unsightly for weeks after stopping, that it may be fatal to pets, and that non-responding lesions should be biopsied. It states no efficacy figure at all, and gives adverse reactions as an unquantified list rather than rates against a comparator.
- TOLERANCE IN USEWEIGHT 15%NOT ASSESSED
Not assessed, and it is the whole experience of this drug: burning, crusting, soreness, ulceration and erosion, by design, for two to four weeks, with visible reaction persisting for several weeks afterwards. A panel would establish the timeline patients most want and no label provides — how long until you look normal again.
- TEXTURE & WEARWEIGHT 10%NOT ASSESSED
Not assessed. A vanishing cream applied twice daily to a face that is being deliberately eroded; the practical question is what can be worn over it, and the answer is probably nothing.
- COST PER APPLICATIONWEIGHT 10%78/100
Around $29 to $36 for a 40 g tube against an average retail near $139 to $203, with the fill weight published and generic fluorouracil widely available. A complete two-to-four-week course for the price of a moisturiser. On cost alone it is the most efficient prescription in this register; the price is paid in weeks of your face rather than in money.
What it is
Fluorouracil, a cytotoxic antimetabolite, applied topically twice daily to a field of actinic keratoses. A 40 g tube of 5% cream, or 10 ml and 25 ml solution dispensers at 2% and 5%. Around $36 with a discount card. In the 5% strength it is also used for superficial basal cell carcinoma where conventional methods are impractical.
A stopping rule made of tissue
Medication should be continued until the inflammatory response reaches the erosion stage, at which time use of the drug should be terminated. The usual duration of therapy is from 2 to 4 weeks. Complete healing of the lesions may not be evident for 1 to 2 months following cessation of EFUDEX therapy.
FDA-approved labelling, Dosage and Administration
Nothing else in this register is dosed like this. There is no course length, no number of applications and no calendar. You continue until your skin reaches a defined state of damage, and then you stop — and the visible consequence outlasts the treatment by a factor of two or three.
For every other topical in this register, irritation is a cost to be minimised — the whole argument of L-09 is that better vehicles buy tolerability. Here the inflammatory reaction is the therapeutic signal. You are meant to reach erosion, because erosion means the atypical cells in the field are being destroyed. That inverts the usual reading of an adverse reaction list, and it is why a patient who has not been warned will stop three days early and get less than they paid for.
The label does warn, in the patient information section, that the reaction may be unsightly during therapy and usually for several weeks following cessation. That sentence is doing more work for a patient than most of the disclosure in this register.
The empty section
There is no clinical studies section on this label. No trial, no success rate, no comparator arm, no sample size, no duration of follow-up. Compare the record for R-54, approved in 2020, which publishes complete clearance rates of 44% and 54% against 5% and 13%, face and scalp separately, with confidence intervals and a twelve-month recurrence follow-up.
Not a comparison of the drugs — a comparison of the documents. Bars are the number of decision-relevant quantities each label publishes: success rate, comparator arm, sample size, treatment duration, recurrence data, and reaction rates against vehicle.
This needs stating carefully, because it would be easy to draw the wrong conclusion. Topical fluorouracil for actinic keratosis is well studied, guideline-supported and widely used; the evidence exists in the literature. What does not exist is any of it on the label, because the product predates the regulatory framework that requires a clinical studies section.
The consequence for a patient is still real. Every figure this site has quoted from a modern label — the number cleared, the number on vehicle, the population it was measured in — is unavailable here. You are being asked to accept two to four weeks of a visibly damaged face on the strength of a clinical consensus you cannot read from the box.
The contraindications
The DPD entry deserves attention because it is the one people have not heard of. Dihydropyrimidine dehydrogenase catabolises most of a fluorouracil dose; without it, the drug is shunted down the cytotoxic pathway. The label describes a single reported case of life-threatening systemic toxicity from the 5% topical cream — severe abdominal pain, bloody diarrhoea, vomiting, fever, stomatitis, neutropenia, thrombocytopenia and inflammation from the oesophagus to the small bowel — and notes that it is unknown whether profoundly DPD-deficient patients would develop systemic toxicity at lower topical concentrations.
'Fluorouracil, including EFUDEX may be fatal if ingested by pets. Avoid allowing pets to contact the EFUDEX container or the skin where EFUDEX has been applied.' The label goes on to say to discard or clean anything that may retain the drug and to avoid leaving residues on hands, clothing, carpeting or furniture. This is a cytotoxic agent being handled twice daily in a bathroom, and the label is the only place anyone will tell you that.
Against R-54
R-54 said the older options run two to four weeks. This is that claim substantiated from the source, and the trade is now legible: roughly eight times the treatment duration, an unquantified outcome, and one-eighth to one-fiftieth of the price. For someone with coverage, the newer drug is straightforwardly better. For someone paying cash, this is a defensible choice made with open eyes — and the eyes need to be open about the weeks, not the money.
If you are considering it
- Have the lesions examined and diagnosed first. The label instructs biopsy of anything that does not respond.
- Establish that pregnancy is not possible during the course. This is a contraindication with reported human birth defects.
- Ask about DPD deficiency, and stop immediately if symptoms suggesting it appear.
- Ask your prescriber what the erosion stage looks like, so you know when to stop rather than guessing.
- Plan the calendar. Two to four weeks of treatment and one to two months of healing is a season, not a fortnight.
- Keep it away from the eyes, nose, mouth and any mucous membrane.
- Do not occlude the area; occlusion increases penetration and the reaction in the surrounding normal skin.
- Stay out of ultraviolet during and immediately after — the reaction intensifies.
- Wash your hands immediately after applying, and keep the tube and your treated skin away from pets.
- Do not stop early because it looks bad. Looking bad is the endpoint.
Where we stand
At 61 this is a genuinely effective, genuinely cheap treatment carrying a label from a different regulatory era, and the score reflects the document rather than the drug. It discloses its risks better than most modern labels and its benefits not at all.
It also makes a point this register keeps circling from other directions. Disclosure is not one thing. A label can be exemplary about who must not take a drug and silent about what taking it achieves. Efudex tells you it may kill your dog and will not tell you how many people it cleared. Renova at R-34 tells you it does not reverse photoageing and publishes the trials that failed. Both are more honest than a compounded product page with a 91% satisfaction figure and no concentration — but they are honest about different halves of the same question.
The five-day alternative, with the clearance figures this label does not have.
The photoageing product whose trials excluded patients with these lesions.
What a label looks like when there is no comparator arm to ask about.
Who this is for
- Someone with multiple actinic keratoses over a field, who can take two to four weeks of a visibly inflamed face and several more of healing.
- Someone paying cash, for whom the difference between $36 and Klisyri's $281 to $1,944 is decisive.
- Someone whose lesions have already been examined and diagnosed, with a plan for biopsying anything that does not respond.
- Someone with no possibility of pregnancy during the course, and no pets likely to lick a treated face.
- You are pregnant or might become pregnant during therapy. This is a contraindication with reported human birth defects.
- You have dihydropyrimidine dehydrogenase deficiency, or symptoms suggesting it develop during treatment.
- You cannot take several weeks of looking visibly unwell, followed by several more of healing.
- You need a defined five-day course and can afford one — R-54 is the alternative.
- You would be applying it near the eyes, nose, mouth or any mucous membrane.
We earn nothing on this link. Ask what the erosion stage looks like and how long you should expect to look unwell — the label says several weeks after you stop, and that is the part people are unprepared for.
This is an editorial assessment of published information about a prescription product. It is not a diagnosis, not a prescription and not a substitute for your own prescriber. Hydroquinone and tretinoin are drugs. Decisions about them belong with a clinician who has seen your skin.
Sources
- S-01FDA-approved labelling — EFUDEX (fluorouracil) cream and topical solution, Bausch Health US, LLC The indication for multiple actinic or solar keratoses and, at 5%, superficial basal cell carcinoma; the dosing instruction to continue until the inflammatory response reaches the erosion stage with a usual duration of 2 to 4 weeks and healing not evident for 1 to 2 months after cessation; the pregnancy contraindication with the reported cleft lip and palate and, on mucous membranes, ventricular septal defect and miscarriage; the DPD enzyme deficiency contraindication and the described case of life-threatening systemic toxicity from the 5% cream; the warnings on occlusion, ultraviolet exposure and mucous membranes; the patient information that the reaction may be unsightly during therapy and for several weeks after; the warning that fluorouracil may be fatal if ingested by pets; the instruction to biopsy non-responding lesions; the adverse reaction list; the 40 g cream tube and 10 ml and 25 ml solution dispensers at 2% and 5% with full excipient lists; and the absence of any clinical studies section. Read 3 August 2026.
- S-02GoodRx — Efudex and generic fluorouracil pricing Generic fluorouracil from around $29.40 against an average retail price near $202.85, with a 40 g tube of 5% averaging about $35.60 with a discount card. Retrieved 3 August 2026.