Prescription medicine
Flutamide Brand names: Eulexin
Flutamide (Eulexin) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the flutamide FDA label on DailyMed (effective February 4, 2025, Waylis Therapeutics LLC); the NDA 18554 record on Drugs@FDA; every flutamide label on DailyMed.
Highlights of the record
FDA label of February 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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.
Used for
From the label: indications and usageEulexin ® 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.
Forms and strengths
- 125 mg
Capsule.
On the market
- Earliest approval on file
- January 27, 1989 Eulexin, Schering; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first September 18, 2001; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 985 through July 30, 2026
What is flutamide used for?
From the label: indications and usageEulexin ® 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.
FDA pharmacologic class: Androgen Receptor Inhibitor.
Source: FDA drug label (Eulexin), Waylis Therapeutics LLC, effective February 4, 2025 (SPL set 0a905e25-42b6-4937-a689-f01a8f22e644), via openFDA; the full label on DailyMed
Is there a generic for flutamide (Eulexin)?
The FDA approved the first generic flutamide on September 18, 2001. 5 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists flutamide from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1989 earliest approval on file
- 2001 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the flutamide label say about other medicines?
The flutamide label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 12 other medicines name flutamide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | Drug Interactions Increases in prothrombin time have been noted in patients receiving long-term warfarin therapy after Eulexin ® was initiated. |
Source: FDA drug label (Eulexin), Waylis Therapeutics LLC, effective February 4, 2025 (SPL set 0a905e25-42b6-4937-a689-f01a8f22e644), via openFDA; the full label on DailyMed
What do FAERS reports show for flutamide?
The FDA Adverse Event Reporting System holds 985 reports that list flutamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 250 are coded as a death and 356 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other androgen receptor inhibitors
- the pharmacologic class, with prices and generics
- Flutamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other