Eulexin Flutamide 125 mg Capsule, 180-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Androgen Receptor Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Flutamide is used together with a luteinizing hormone-releasing hormone agonist (LHRH; a type of hormonal injection such as leuprolide [Lupron, Eligard], goserelin [Zoladex], or triptorelin [Trelstar]) to treat certain types of prostate cancer. Flutamide is in a class of medications called nonsteroidal antiandrogens. It works by blocking the effects of androgen (a male hormone) to stop the growth and spread of cancer cells.
Read the full MedlinePlus article ↗- Flutamide needs to be paired with an LHRH agonist because the two work together to block testosterone from fueling prostate cancer. The LHRH agonist dramatically lowers your body's...
- Why do I have to take another shot (LHRH agonist) along with this pill — can't I just take flutamide by itself?
- That color change is actually a known and harmless side effect of Eulexin and its byproducts in your body. It doesn't mean something is wrong with your kidneys or bladder. That sai...
- My urine looks a strange amber or greenish color — should I be worried?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Flutamide — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $44.91 | $8,083.42 / 180 capsules |
| Medicare Part B allowsASP · J8999 | No ASP payment limit on file for J8999 this quarter. | |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Eulexin 125 mgthis 80725-0143-18 | Waylis | 180 capsules | — | — | FDA listed | — |
| Eulexin 125 mg 80725-0600-18 | Waylis | 180 capsules | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 80725-0143-18 You're viewing this | 1 BOTTLE, PLASTIC in 1 BOX (80725-143-18) / 180 CAPSULE in 1 BOTTLE, PLASTIC | 2021-11-12 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNINGS Hepatic Injury There have been postmarketing reports of hospitalization and rarely death due to liver failure in patients taking Eulexin ® . Evidence of hepatic injury included elevated serum transaminase levels, jaundice, hepatic encephalopathy and death related to acute hepatic failure. The hepatic injury was reversible after discontinuation of therapy in some patients.
Approximately half of the reported cases occurred within the initial 3 months of treatment with Eulexin ® . Serum transaminase levels should be measured prior to starting treatment with Eulexin ® . Eulexin ® is not recommended in patients whose ALT values exceed twice the upper limit of normal.
Serum transaminase levels should then be measured monthly for the first 4 months of therapy, and periodically thereafter. Liver function tests also should be obtained at the first signs and symptoms suggestive of liver dysfunction, e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, "flu-like" symptoms, hyperbilirubinuria, jaundice or right upper quadrant tenderness. If at any time, a patient has jaundice, or their ALT rises above 2 times the upper limit of normal, Eulexin ® should be immediately discontinued with close follow-up of liver function tests until resolution.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Eulexin ® capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy. Stage D 2 Metastatic Carcinoma To achieve benefit from treatment, Eulexin ® capsules should be initiated with the LHRH-agonist and continued until progression.
⏱️ Dosage and Administration ▾
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.
⛔ Contraindications ▾
CONTRAINDICATIONS Eulexin ® capsules are contraindicated in patients who are hypersensitive to Eulexin ® or any component of this preparation. Eulexin ® capsules are contraindicated in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment).
⚠️ Warnings ▾
WARNINGS Hepatic Injury SEE BOXED WARNINGS Use in Women Eulexin ® capsules are for use only in men. This product has no indication for women and should not be used in this population, particularly for nonserious or nonlife-threatening conditions. Fetal toxicity Eulexin ® may cause fetal harm when administered to a pregnant woman (see Pregnancy ).
Aniline toxicity One metabolite of Eulexin ® is 4-nitro-3-fluoro-methylaniline. Several toxicities consistent with aniline exposure, including methemoglobinemia, hemolytic anemia and cholestatic jaundice have been observed in both animals and humans after Eulexin ® administration. In patients susceptible to aniline toxicity (e.g. persons with glucose-6-phosphate dehydrogenase deficiency, hemoglobin M disease and smokers), monitoring of methemoglobin levels should be considered.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant did not add substantially to the toxicity of radiation treatment alone. The following adverse experiences were reported during a multicenter clinical trial comparing Eulexin ® + goserelin acetate implant + radiation versus radiation alone. The most frequently reported (greater than 5%) adverse experiences are listed below: Adverse Events During Acute Radiation Therapy (within first 90 days of radiation therapy) (n=231) Goserelin Acetate Implant + Eulexin ® + Radiation (n=235) Radiation Only % All % All Rectum/Large Bowel 80 76 Bladder 58 60 Skin 37 37 Adverse Events During Late Radiation Phase (after 90 days of radiation therapy) (n=231) Goserelin Acetate Implant + Eulexin ® + Radiation (n=235) Radiation Only % All % All Diarrhea 36 40 Cystitis 16 16 Rectal Bleeding 14 20 Proctitis 8 8 Hematuria 7 12 Additional adverse event data were collected for the combination therapy with radiation group over both the hormonal treatment and hormonal treatment plus radiation phases of the study.
Adverse experiences occurring in more than 5% of patients in this group, over both parts of the study, were hot flashes (46%), diarrhea (40%), nausea (9%), and skin rash (8%). Stage D 2 Metastatic Carcinoma The following adverse experiences were reported during a multicenter clinical trial comparing Eulexin ® + LHRH agonist versus placebo + LHRH agonist. The most frequently reported (greater than 5%) adverse experiences during treatment with Eulexin ® capsules in combination with an LHRH agonist are listed in the table below.
For comparison, adverse experiences seen with an LHRH agonist and placebo are also listed in the following table. (n=294) Eulexin ® + LHRH agonist (n=28) Placebo + LHRH agonist % All % All Hot Flashes 61 57 Loss of Libido 36 31 Impotence 33 29 Diarrhea 12 4 Nausea/Vomiting 11 10 Gynecomastia 9 11 Other 7 9 Other GI 6 4 As shown in the table, for both treatment groups, the most frequently occurring adverse experiences (hot flashes, impotence, loss of libido) were those known to be associated with low serum androgen levels and known to occur with LHRH agonists alone.
The only notable difference was the higher incidence of diarrhea in the Eulexin ® + LHRH agonist group (12%), which was severe in 5% as opposed to the placebo + LHRH agonist (4%), which was severe in less than 1%. In addition, the following adverse reactions were reported during treatment with Eulexin ® + LHRH agonist. Cardiovascular System: hypertension in 1% of patients.
Central Nervous System : CNS (drowsiness/confusion/depression/anxiety/nervousness) reactions occurred in 1% of patients. Gastrointestinal System : anorexia 4%, and other GI disorders occurred in 6% of patients. Hematopoietic System : anemia occurred in 6%, leukopenia in 3%, and thrombocytopenia in 1% of patients.
Liver and Biliary System : hepatitis and jaundice in less than 1% of patients. Skin : irritation at the injection site and rash occurred in 3% of patients. Other: edema occurred in 4%, genitourinary and neuromuscular symptoms in 2%, and pulmonary symptoms in less than 1% of patients.
In addition, the following spontaneous adverse experiences have been reported during the marketing of Eulexin ® : hemolytic anemia,macrocytic anemia,methemoglobinemia, sulfhemoglobinemia, photosensitivity reactions (including erythema, ulceration, bullous eruptions, and epidermal necrolysis) and urine discoloration. The urine was noted to change to an amber or yellow-green appearance which can be attributed to the Eulexin ® and/or its metabolites. Also reported were cholestatic jaundice, hepatic encephalopathy, and hepatic necrosis.
The hepatic conditions were often reversible after discontinuing therapy; however, there have been reports of death following severe hepatic injury associated with use of Eulexin ® . Malignant breast neoplasms have occurred rarely in male patients being treated wi…
🔄 Drug Interactions ▾
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.
🤰 Pregnancy ▾
Pregnancy Pregnancy Category D There was decreased 24 hour survival in the offspring of pregnant rats treated with Eulexin ® at doses of 30, 100 or 200 mg/kg/day (approximately 3, 9 and 19 times the human dose). A slight increase in minor variations in the development of the sternebrae and vertebrae was seen in fetuses of rats treated with two higher doses. Feminization of the male rats also occurred at the two higher dose levels.
There was a decreased survival rate in the offspring of rabbits receiving the highest dose (15 mg/kg/day, equal to 1.4 times the human dose).
🆘 Overdosage ▾
OVERDOSAGE In animal studies with Eulexin ® alone, signs of overdose included hypoactivity, piloerection, slow respiration, ataxia, and/or lacrimation, anorexia, tranquilization, emesis, and methemoglobinemia. Clinical trials have been conducted with Eulexin ® in doses up to 1500 mg per day for periods up to 36 weeks with no serious adverse effects reported. Those adverse reactions reported included gynecomastia, breast tenderness, and some increases in SGOT.
The single dose of Eulexin ® ordinarily associated with symptoms of overdose or considered to be life-threatening has not been established. Eulexin ® is highly protein bound, and is not cleared by hemodialysis. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.
If vomiting does not occur spontaneously, it should be induced if the patient is alert. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY General In animal studies, flutamide demonstrates potent antiandrogenic effects. It exerts its antiandrogenic action by inhibiting androgen uptake and/or by inhibiting nuclear binding of androgen in target tissues or both. Prostatic carcinoma is known to be androgen-sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen, e.g., castration.
Elevations of plasma testosterone and estradiol levels have been noted following flutamide administration. Pharmacokinetics Absorption Analysis of plasma, urine, and feces following a single oral 200 mg dose of tritium-labeled Eulexin ® to human volunteers showed that the drug is rapidly and completely absorbed. Following a single 250 mg oral dose to normal adult volunteers, the biologically active alpha-hydroxylated metabolite reaches maximum plasma concentrations in about 2 hours, indicating that it is rapidly formed from flutamide.
Food has no effect on the bioavailability of flutamide. Distribution In male rats administered an oral 5 mg/kg dose of 14 C-flutamide neither flutamide nor any of its metabolites is preferentially accumulated in any tissue except the prostate. Total drug levels were highest 6 hours after drug administration in all tissues.
Levels declined at roughly similar rates to low levels at 18 hours. The major metabolite was present at higher concentrations than Eulexin ® in all tissues studied. Following a single 250 mg oral dose to normal adult volunteers, low plasma concentrations of Eulexin ® were detected.
The plasma half-life for the alpha-hydroxylated metabolite of Eulexin ® is approximately 6 hours. Eulexin ® , in vivo , at steady-state plasma concentrations of 24 to 78 ng/mL, is 94% to 96% bound to plasma proteins. The active metabolite of Eulexin ® , in vivo , at steady-state plasma concentrations of 1556 to 2284 ng/mL, is 92% to 94% bound to plasma proteins.
Metabolism The composition of plasma radioactivity, following a single 200 mg oral dose of tritium-labeled Eulexin ® to normal adult volunteers, showed that Eulexin ® is rapidly and extensively metabolized, with Eulexin ® comprising only 2.5% of plasma radioactivity 1 hour after administration. At least six metabolites have been identified in plasma. The major plasma metabolite is a biologically active alpha-hydroxylated derivative which accounts for 23% of the plasma tritium 1 hour after drug administration.
The major urinary metabolite is 2-amino-5nitro-4-(trifluoromethyl)phenol. Excretion Eulexin ® and its metabolites are excreted mainly in the urine with only 4.2% of a single dose excreted in the feces over 72 hours. Plasma Pharmacokinetics of flutamide and Hydroxyflutamide in Geriatric Volunteers (mean ± SD) Single Dose flutamide Hydroxyflutamide Steady-State flutamide Hydroxyflutamide C max (ng/mL) 25.2 ± 34.2 894 ± 406 113 ± 213 1629 ± 586 Elimination half-life (hr) — 8.1 ± 1.3 7.8 9.6 ±
2.5T max (hr) 1.9 ± 0.7 2.7 ± 1.0 1.3 ± 0.7 1.9 ±
0.6C min (ng/mL) — — — 673 ± 316 Special Populations Geriatric Following multiple oral dosing of 250 mg t.i.d. in normal geriatric volunteers, Eulexin ® and its active metabolite approached steady-state plasma levels (based on pharmacokinetic simulations) after the fourth Eulexin ® dose. The half-life of the active metabolite in geriatric volunteers after a single Eulexin ® dose is about 8 hours and at steady-state in 9.6 hours. Race There are no known alterations in Eulexin ® absorption, distribution, metabolism, or excretion due to race.
Renal Impairment Following a single 250 mg dose of Eulexin ® administered to subjects with chronic renal insufficiency, there appeared to be no correlation between creatinine clearance and either C max or AUC of Eulexin ® . Renal impairment did not have an effect on the C max or AUC of the biologically active alpha- hydroxylated metabolite of Eulexin ® . In subjects with creatinine clearance of < 29 mL/min, the half-life of the active metabolite was sl…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Eulexin ® capsules USP, 125 mg, are available as opaque, beige/beige capsules, imprinted "w 753" on the cap and body. They are available in bottle of 180 (NDC 80725-143-18). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
📋 Description ▾
DESCRIPTION Eulexin ® capsules contain flutamide, an acetanilid, nonsteroidal, orally active antiandrogen having the chemical name, α,α,α-trifluoro-2-methyl-4'-nitro- m -propionotoluidide. Each capsule contains 125 mg flutamide. The compound is a buff to yellow powder with a molecular weight of 276.22 and the following structural formula: C 11 H 11 F 3 N 2 O 3 In addition, each capsule contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, povidone, and sodium lauryl sulfate.
Gelatin capsule shells may contain gelatin, silicon dioxide, sodium lauryl sulfate, titanium dioxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide, and black ink containing pharmaceutical glaze (modified) in SD-45, synthetic black iron oxide, N-butyl alcohol, SDA-3A alcohol, FD&C Blue No.2 Aluminum Lake, FD&C Red No.40 Aluminum Lake, FD&C Blue No.1 Aluminum Lake, and D&C Yellow No.10 Aluminum Lake. Chemical Structure
💬 Information for Patients ▾
Information for Patients Patients should be informed that Eulexin ® capsules and the drug used for medical castration should be administered concomitantly, and that they should not interrupt their dosing or stop taking these medications without consulting their physician.