Prescription medicine
Nilutamide First approved as Nilandron
Nilutamide (Nilandron) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the nilutamide FDA label on DailyMed (effective June 26, 2026, ANI Pharmaceuticals, Inc.); the NDA 20169 record on Drugs@FDA; every nilutamide label on DailyMed.
Highlights of the record
FDA label of June 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Interstitial Pneumonitis Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to nilutamide. A small study in Japanese subjects showed that 8 of 47 patients (17%) developed interstitial pneumonitis. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases occurred within the first 3 months of treatment with Nilutamide Tablets, and most reversed with discontinuation of therapy. A routine chest X-ray should be performed prior to initiating treatment with Nilutamide Tablets. Baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath that they experience while on Nilutamide Tablets. If symptoms occur, Nilutamide Tablets should be immediately discontinued until it can be determined if the symptoms are drug related.
Used for
From the label: indications and usageMetastatic Prostate Cancer Nilutamide Tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D 2 ).
Forms and strengths
- 150 mg
Tablet.
On the market
- Earliest approval on file
- September 19, 1996 Nilandron, Advanz Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first July 15, 2016; 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)
- None current 2 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 74 through July 30, 2026
What is nilutamide used for?
From the label: indications and usageMetastatic Prostate Cancer Nilutamide Tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D 2 ). For maximum benefit, treatment with Nilutamide Tablets must begin on the same day as or on the day after surgical castration.
Conditions named in the indications of nilutamide's FDA labels, with every medicine labeled for each:
From other nilutamide labelsProstate cancer: INDICATIONS AND USAGE Metastatic Prostate Cancer Nilutamide Tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D 2 ).
FDA pharmacologic class: Androgen Receptor Inhibitor.
Source: FDA drug label (Nilutamide), ANDA207631 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective June 26, 2026 (SPL set d5740b8f-fbb3-4023-9133-9e359a9ab980), via openFDA; the full label on DailyMed
Is there a generic for nilutamide (Nilandron)?
The FDA approved the first generic nilutamide on July 15, 2016. 1 generic application is approved; 1 of it 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 nilutamide 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.
- 1996 earliest approval on file
- 2016 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is nilutamide in shortage?
No nilutamide presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated December 1, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Nilandron, Tablet, 150 mg (NDC 59212-111-14) | Advanz Pharma (US) Corp. | To Be Discontinued | December 1, 2025 |
| Nilandron, Tablet, 150 mg (NDC 66993-212-38) | Advanz Pharma (US) Corp. | To Be Discontinued | December 1, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the nilutamide label say about other medicines?
The nilutamide label names 2 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Phenytoin | drug interactions | Consequently, drugs with a low therapeutic margin, such as vitamin K antagonists, phenytoin, and theophylline, could have a delayed elimination and increases in their serum half-life leading to a toxic level. |
| Theophylline | drug interactions | Consequently, drugs with a low therapeutic margin, such as vitamin K antagonists, phenytoin, and theophylline, could have a delayed elimination and increases in their serum half-life leading to a toxic level. |
Source: FDA drug label (Nilutamide), ANDA207631 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective June 26, 2026 (SPL set d5740b8f-fbb3-4023-9133-9e359a9ab980), via openFDA; the full label on DailyMed
What do FAERS reports show for nilutamide?
The FDA Adverse Event Reporting System holds 74 reports that list nilutamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 19 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as nilutamide?
6 other medicines are given the same way (oral) and in the same FDA class as nilutamide or labeled mainly for the same use (prostate cancer), the same class first. Prostate cancer lists all 17 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Enzalutamide | Prostate cancer | none listed | n/a | No current entry |
| Abiraterone | Prostate cancer | 24 labelers | $0.774 per tablet 250 mg tablet | No current entry |
| Rucaparib camsylate | Prostate cancer | none listed | n/a | No current entry |
| Abiraterone and niraparib | Prostate cancer | none listed | n/a | No current entry |
| Apalutamide | Prostate cancer | none listed | n/a | No current entry |
| Relugolix | Prostate cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as nilutamide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to nilutamide
- 6 medicines for the same use
- Other androgen receptor inhibitors
- the pharmacologic class, with prices and generics
- Nilutamide side effects
- the label's list beside FAERS reports
- Nilutamide shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other