Drug Notebook

FDA Alerts

    Interstitial Pneumonitis
  • Interstitial pneumonitis, rarely resulting in hospitalization or death, reported. Manifestations generally occurred within the first 3 months of therapy and resolved following discontinuance of the drug.
  • Immediately discontinue therapy if dyspnea or worsening of preexisting dyspnea occurs. (See Interstitial Pneumonitis under Cautions.)

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nilutamide
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(nih LUTE ah mide)

What is the most important information I should know about nilutamide?

Call your doctor immediately if you develop yellow skin or eyes, dark urine, itching, persistent appetite loss, pain in the upper right stomach area, unexplained "flu-like" symptoms, difficulty breathing, shortness of breath, cough, chest pain, or fever. Alcohol may cause facial flushing, dizziness, and other symptoms in approximately 5% of patients when used during treatment with nilutamide. Do not drink alcohol if you experience any of these symptoms.

Nilutamide may cause a delay in your ability to see in the dark after being in a lighted area. Use caution when driving at night, when entering into a tunnel, and in other similar situations. Tinted glasses may alleviate this side effect.

What is nilutamide?

Nilutamide is an antiandrogen. It works in the body to prevent the actions of androgens (male hormones).

Nilutamide is used in the treatment of prostate cancer.

Nilutamide may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking nilutamide?

Before taking this medication, tell your doctor if you have

You may not be able to take nilutamide, or you may require a lower dose or special monitoring if you have any of the conditions listed above.

Nilutamide is in the FDA pregnancy category C. This means that it is not known whether nilutamide will harm an unborn baby. Nilutamide is not indicated for use by women. Do not take this medication if you are pregnant or are planning a pregnancy. It is not known whether nilutamide passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take nilutamide?

Take nilutamide exactly as directed by your doctor. However, if you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Take each dose with a full glass of water.

Nilutamide can be taken with or without food or milk.

Treatment with nilutamide should be started on the day of or on the day after surgical castration to have maximum benefits.

Try to take your dose of nilutamide at the same time every day.

Do not stop taking this medication without first talking to your doctor. Store nilutamide at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a nilutamide overdose are not known but might include decreased activity, slow breathing, dizziness, watering eyes, decreased appetite, vomiting, and sedation.

What should I avoid while taking nilutamide?

Alcohol may cause facial flushing, dizziness, and other symptoms in approximately 5% of patients when used during treatment with nilutamide. Do not drink alcohol if you experience any of these symptoms.

Nilutamide may cause a delay in your ability to see in the dark after you have been in a lighted area. Use caution when driving at night, when entering a tunnel, and in similar situations. Tinted glasses may alleviate this side effect.

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