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What Is Nilutamide (Nilandron®)?


Nilandron® (nilutamide) is an androgen receptor inhibitor, also called an antiandrogen or a nonsteroidal antiandrogen (NSAA), used in combination with surgical castration (removal of the testicles), and potentially in combination with LHRH (or GnRH) agonists. It is indicated for use in combination with surgical castration in individuals with metastatic prostate cancer (prostate cancer that has spread to another part of the body). Nilutamide is an orally administered medication that comes in tablet form. Individuals taking Nilutamide should also be monitored for changes in liver functioning as well as for signs of interstitial pneumonitis (also known as interstitial lung disease).

What are the ingredients in nilutamide?

The active ingredient in nilutamide is nilutamide, the nonsteroidal antiandrogen.

How does nilutamide work?

Nilutamide’s active ingredient binds to the androgen receptors in the body. Nilutamide blocks testosterone and other androgens from activating these receptors. Prostate cancer tumors are often fueled to grow by androgens, including testosterone. Turning off the body’s ability to respond to testosterone can potentially halt tumor growth. In addition, nilutamide can be used during early stages of other hormone therapies, such as treatment with Gonadotropin-Releasing Hormone (GnRH) agonists, in order to block the initial surge of testosterone, called tumor flare, that can come along with these medications. The surge of testosterone at the beginning of some of these treatment methods can contribute to rapid tumor growth before it is halted, potentially leading to life-threatening issues such as spinal cord compression.

What are the possible side effects of nilutamide?

Multiple clinical trials evaluated the safety and efficacy of nilutamide. The most common side effects of nilutamide include hot flashes, delayed vision adjustment to darkness, breast pain or enlargement, decreased sex drive, erectile dysfunction, nausea, diarrhea, fatigue, pain, swelling, loss of appetite, constipation, headache, and difficulty sleeping. This is not an exhaustive list of all potential side effects of nilutamide. Talk to your healthcare provider or pharmacist for further information.

Things to note about nilutamide

Several rare but more serious side effects can accompany nilutamide including problems with your liver. Individuals should be closely monitored for signs of these serious side effects, and blood tests to assess liver function should be performed regularly. Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their nilutamide regimen. Alert your provider immediately if you notice any of the following symptoms:

  • Nausea and vomiting
  • Stomach or abdominal pain
  • Flu-like symptoms like soreness or muscle aches
  • Fatigue
  • Brown urine
  • Yellowing of the skin or whites of eyes (jaundice)
  • Loss of appetite
  • Inability to urinate

Additionally, although rare, there is a chance of developing interstitial pneumonitis, also called interstitial lung disease, while on nilutamide. You provider will monitor you for signs of interstitial pneumonitis, however, you should alert them immediately if you notice any of the following:

  • Difficulty breathing
  • Coughing
  • Chest pain
  • Fever

Before starting nilutamide talk to your provider if you:

  • Have any liver, heart, kidney, or lung problems
  • Are taking any blood thinners
  • Have a partner who is pregnant or could become pregnant
  • Have any other medical conditions
  • Are currently taking any other medications, vitamins, or herbal supplements

You should also contact your provider if you notice any signs of an allergic reaction to the medication, including chest pain or difficulty breathing. Since drowsiness, blurred vision, or dizziness may occur, individuals on nilutamide should refrain from operating heavy machinery, or driving unless specifically instructed otherwise. It is also important to drink substantial amounts of water while taking nilutamide. Alcohol should be avoided while taking nilutamide, because the combination may cause a bad reaction. It is also important to consult the prescribing information for any other medications taken with nilutamide, including LHRH agonists.

Dosing information

Nilutamide is administered orally and is commonly taken with a LHRH (or GnRH) agonist or immediately after castration surgery. Typically, nilutamide is taken once daily and comes in a 150 mg tablet. Your provider will determine the appropriate dosage and administration schedule for you, as well as the appropriate dosage and administration of any other medications taken with nilutamide. It is important to follow this schedule exactly as instructed, and not to stop taking nilutamide or any accompanying medications on your own. If you miss a dose of nilutamide take your prescribed dose as soon as you remember. If you remember near the time of the next dose, skip the missed dose and take your regularly scheduled dosage as normal, and do not try to make up for missed doses. Nilutamide can be taken with or without food. If you take too much nilutamide, seek emergency medical attention immediately.1

Written by: Casey Hribar | Last reviewed: July 2019
  1. Nilandron Prescribing Information. Sanofi Aventis. June 2006. Available from: