Flutamide
Flutamide is an anti-androgen (male hormone-blocking) medicine used together with an LHRH-agonist hormone therapy to treat prostate cancer.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Flutamide (Eulexin) is an older anti-androgen, a medicine that blocks male hormones from fueling prostate cancer, used together with an LHRH-agonist therapy; on the market since about 1989 and available as a generic, it is now used less often than newer blockers such as bicalutamide. Side effects are common but usually manageable, mainly hot flashes, lower sex drive, breast enlargement and diarrhea, which tends to be worse with this drug than with its newer relatives. The one thing to look for is its boxed warning for serious liver injury, so report yellowing skin or eyes, dark urine, or upper right belly pain promptly and keep every liver blood test.
Clinical pearls
- Expect liver blood tests before starting and monthly for the first 4 months, when liver problems most often show up.
- If you take warfarin, flutamide can strengthen its effect, so plan extra clotting checks and possible warfarin dose changes.
- Amber or yellow-green urine can simply be the drug, but dark urine with nausea or fatigue needs a liver check.
- Smokers and people with G6PD deficiency are more prone to blood problems, so report bluish-gray skin, paleness or unusual tiredness.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Eulexin can cause serious liver injury, including liver failure that has led to hospitalization and, rarely, death. About half of the reported cases happened within the first 3 months of treatment. In some people the liver injury reversed after the medicine was stopped.
Liver blood tests (ALT) should be done before you start, monthly for the first 4 months, and periodically afterward. Eulexin is not recommended if your ALT is more than twice the upper limit of normal.
Watch for nausea, vomiting, belly pain, fatigue, loss of appetite, flu-like symptoms, dark urine, yellowing of the skin or eyes, or tenderness in the upper right abdomen. If you develop jaundice or your ALT rises above twice the upper limit of normal, Eulexin should be stopped right away with close follow-up of your liver tests.
Patient information guide A plain-language walkthrough of Flutamide, written from its FDA label.
What Flutamide is used for
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Flutamide is used to treat prostate cancer in men, in combination with an LHRH-agonist.
- Eulexin capsules: locally confined Stage B2-C prostate cancer, with the goserelin acetate implant started eight weeks before radiation and continued during it.
- Eulexin capsules: Stage D2 metastatic prostate cancer, started with the LHRH-agonist and continued until progression.
How Flutamide works
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Prostate cancer is androgen-sensitive, meaning male hormones help it grow. In animal studies, flutamide showed strong antiandrogenic effects. It works by blocking androgen uptake and/or its binding in the cell nucleus of target tissues.
Blood levels of testosterone and estradiol have been seen to rise after flutamide.
Flutamide dosage
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Eulexin is taken by mouth as capsules, 3 times a day at 8-hour intervals. Food does not affect how well it is absorbed. It is taken together with an LHRH-agonist, with timing that depends on the stage of cancer.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Flutamide prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (no specific condition named in the dosing text)
- 2 capsules 3 times a day at 8 hour intervals for a total daily dose of 750 mg
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION The recommended dosage is 2 capsules 3 times a day at 8 hour intervals for a total daily dose of 750 mg.
Read the full Dosage and Administration section on DailyMed →
Flutamide side effects
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Many side effects come from low male hormone levels and also occur with LHRH-agonists alone.
Common side effects
- Hot flashes
- Loss of sex drive (libido)
- Impotence
- Diarrhea
- Nausea and vomiting
- Breast enlargement (gynecomastia)
- Skin rash
- Reduced appetite
- Swelling (edema)
When to get medical help
- Call your doctor right away if you notice yellowing of the skin or eyes (jaundice) or dark urine.
- Report nausea, vomiting, belly pain, fatigue, loss of appetite, flu-like symptoms, or pain in the upper right abdomen. These can be early signs of liver trouble.
- Severe or persistent diarrhea needs a call to your doctor.
- Tell your doctor about unusual tiredness, paleness, or blue-gray skin color. These can point to blood problems such as hemolytic anemia or methemoglobinemia.
- Report skin reactions after sun exposure, such as redness, blistering, or ulcers.
- Report any breast lumps. Breast cancer has rarely been reported in men taking Eulexin.
Flutamide warnings and precautions
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- Liver injury: can be serious or fatal. Liver tests are needed before and during treatment.
- Aniline toxicity: methemoglobinemia, hemolytic anemia, and cholestatic jaundice can occur. G6PD deficiency, hemoglobin M disease, and smoking raise susceptibility.
- Men only: not for use in women, and it may cause fetal harm.
- Breast cancer: malignant breast tumors have rarely occurred in men taking it.
- Photosensitivity: serious skin reactions to light have been reported.
Flutamide interactions
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The key interaction is with warfarin.
- Warfarin: prothrombin time has increased in long-term warfarin users after starting Eulexin, so close monitoring and a dose adjustment may be needed.
- LHRH-agonists: no interactions have occurred between them and Eulexin.
Interactions listed in the FDA-approved label
From the Flutamide prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Warfarin: Increases in prothrombin time have been noted in patients receiving long-term warfarin therapy after Eulexin was initiated. Close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when Eulexin capsules are administered concomitantly with warfarin.
Read the label’s full interactions text
Drug Interactions Increases in prothrombin time have been noted in patients receiving long-term warfarin therapy after Eulexin ® was initiated. Therefore close monitoring of prothrombin time is recommended and adjustment of the anticoagulant dose may be necessary when Eulexin ® capsules are administered concomitantly with warfarin.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Flutamide
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- Do not use if allergic to flutamide or any ingredient.
- Do not use with severe liver impairment; liver enzymes are checked first.
- Not recommended if ALT is above twice the upper limit of normal.
- For men only; not for women and may harm a fetus.
- Not studied in children.
- Kidney impairment does not call for a dose change.
- Tell your doctor about G6PD deficiency, hemoglobin M disease, smoking, or warfarin use.
Flutamide overdose
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In animal studies, overdose caused low activity, slow breathing, unsteadiness, vomiting, and methemoglobinemia. People in trials took higher daily amounts for up to 36 weeks without serious effects, though breast tenderness, gynecomastia, and raised liver enzymes were reported. Treatment is supportive care with close monitoring; dialysis does not remove it, and vomiting should be induced if the patient is alert and does not vomit on their own.
What Flutamide does in the body
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Flutamide blocks the action of androgens in target tissues, which matters because prostate cancer is androgen-sensitive. It can raise plasma testosterone and estradiol levels.
How your body processes Flutamide
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Flutamide is absorbed rapidly and completely, and food does not affect it. It is quickly converted into an active metabolite that peaks in about 2 hours and has a half-life of roughly 6 to 10 hours. Both are highly protein bound. Most of the drug leaves through the urine, which can turn amber or yellow-green. Kidney impairment does not require a dose adjustment.
How to store Flutamide
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Store at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Flutamide
189 supplements and herbal products have documented interactions with Flutamide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 143
- Minor · 43
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Flutamide: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Flutamide — the kind of thing our pharmacy team would talk through with you at the counter.
What is flutamide for?
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How do I take it?
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What side effects should I expect?
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Why do I need blood tests?
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Does it interact with other medicines?
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Can women take it?
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Is Flutamide available over the counter?
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When was Flutamide first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Flutamide on HelloPharmacist
Flutamide forms and strengths (how it comes)
Flutamide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Eulexin capsules are used with LHRH-agonists for locally confined Stage B2-C prostate cancer.
- Eulexin capsules are used with LHRH-agonists for Stage D2 metastatic prostate cancer.
- Eulexin is taken by mouth as 2 capsules, 3 times a day at 8-hour intervals.
- Eulexin for Stage B2-C disease starts eight weeks before radiation with the goserelin acetate implant and continues during radiation.
- Eulexin for Stage D2 disease starts with the LHRH-agonist and continues until progression.
Flutamide on the U.S. market: products, makers and brands
How Flutamide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Flutamide product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1989. Brand names on the directory include Eulexin; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Flutamide products
A representative set of FDA-listed product records for Flutamide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 125 mg | Oral | Waylis Therapeutics LLC × 2 listings | ANDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Flutamide NDCs →
Flutamide side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Flutamide — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Flutamide in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Flutamide FDA approval history
How Flutamide went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Flutamide recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Flutamide recalls since July 2021.
✅No Flutamide recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4508 2 dose forms · 2 strengths
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Dose form (SCDF) Oral Capsule RxCUI 372251In current FDA listingsClinical drug / strength (SCD) 125 MGRxCUI 197726 -
Dose form (SCDF) Oral Tablet RxCUI 372252No current FDA listingClinical drug / strength (SCD) 250 MGRxCUI 199609
Look up RxCUI 4508 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Flutamide supply and shortage status
Whether Flutamide is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Flutamide brand names
Flutamide is sold under one brand name in the FDA directory — Eulexin. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Flutamide: manufacturers and labelers
One company lists Flutamide products with the FDA. By number of product records, the largest are Waylis Therapeutics LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Flutamide drug class (RxNorm)
Flutamide belongs to the Androgen Receptor Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Flutamide page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Waylis Therapeutics LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →