Nilutamide

Generic Name: nilutamide (nye-LOO-tah-mide)
Brand Name: Nilandron

Nilutamide may infrequently cause lung problems (interstitial pneumonitis), which, rarely, may be fatal. Seek immediate medical attention if any of these unlikely, but serious, side effects occur: chest pain, fever, persistent cough, trouble breathing. These side effects have usually occurred within the first 3 months of treatment with nilutamide. Laboratory and/or medical tests (eg, chest x-ray, lung function) may be performed to monitor your progress or to check for side effects.


Nilutamide is used for:

Treating prostate cancer, along with surgical procedures.

Nilutamide is an antiandrogen. It works by preventing androgens (eg, testosterone) from binding to and activating tumor cells of the prostate.

Do NOT use nilutamide if:

  • you are allergic to any ingredient in nilutamide
  • you are a woman
  • you have severe liver or breathing problems

Contact your doctor or health care provider right away if any of these apply to you.

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Before using nilutamide:

Some medical conditions may interact with nilutamide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver or breathing conditions

Some MEDICINES MAY INTERACT with nilutamide. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Phenytoin, theophylline, or vitamin K antagonists (eg, warfarin) because side effects and toxic effects may be increased by nilutamide

This may not be a complete list of all interactions that may occur. Ask your health care provider if nilutamide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use nilutamide:

Use nilutamide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Nilutamide may be taken with or without food.
  • Nilutamide should be started on the day of or the day after surgery.
  • If you miss a dose of nilutamide, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use nilutamide.

Important safety information:

  • Nilutamide may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to nilutamide. Using nilutamide alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • Do not drink alcohol while taking his medicine. Nilutamide may cause alcohol intolerance (facial flushing, general body discomfort, lightheadedness).
  • Nilutamide may cause changes in eyesight, especially when moving from light to dark areas. Wearing sunglasses when you are in bright light may be helpful.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using nilutamide.
  • LAB TESTS, including liver function or serum transaminase levels, may be performed to monitor therapy or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Nilutamide is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using nilutamide during pregnancy. It is unknown if nilutamide is excreted in breast milk. Do not breast-feed while taking nilutamide.

Possible side effects of nilutamide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in eyesight; constipation; decreased sexual desire; difficulty sleeping; dizziness; frequent or painful urination; hot flashes; impaired adaptation to darkness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; cough; dark urine; fatigue; fever; flu-like symptoms (headache, tiredness, muscle aches, sore throat); loss of appetite; nausea; shortness of breath; stomach pain; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include dizziness; general discomfort; nausea; vomiting.

Proper storage of nilutamide:

Store nilutamide at room temperature, 59 to 86 degrees F (15 to 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep nilutamide out of the reach of children and away from pets.

General information:

  • If you have any questions about nilutamide, please talk with your doctor, pharmacist, or other health care provider.
  • Nilutamide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take nilutamide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about nilutamide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to nilutamide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using nilutamide.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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