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Nilandron

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Nilandron

Nilandron Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Nilandron (nilutamide) is used in the treatment of prostate cancer. It is an antiandrogen. It works in the body to prevent the actions of androgens (male hormones). Common side effects include hot flashes, sweating, dizziness, loss of sexual interest/ability, vision changes (such as difficulty seeing when moving into the dark or light, changes in color vision), stomach pain, constipation, nausea, signs of alcohol intolerance (such as flushing, tiredness) dry skin, increased sensitivity to touch/pain, and loss of body hair. Because Nilandron may be used with other medications, the side effects may be due to any one medicine or the combination of medications.

The recommended dosage of Nilandron is 300 mg once a day for 30 days, followed thereafter by 150 mg once a day. Nilandron may interact with warfarin, phenytoin, or theophylline. Tell your doctor all medications and supplements you use. Nilandron should not be used in women. It may harm a fetus. It is unknown if this drug passes into breast milk. Women who are pregnant or breastfeeding should avoid touching or accidentally taking this medication.

Our Nilandron (nilutamide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nilandron in Detail - Patient Information: Side Effects

If you experience any of the following serious side effects, stop taking nilutamide, and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives),
  • shortness of breath, cough, chest pain, or fever;
  • liver damage (yellow skin or eyes, dark urine, itching, persistent appetite loss, pain in the upper right stomach area, or unexplained flulike symptoms).

Other less serious side effects may be more likely to occur. Continue to take nilutamide and talk to your doctor if you experience

  • hot flashes,
  • dizziness,
  • constipation,
  • nausea or vomiting,
  • skin rash,
  • loss of appetite,
  • decreased libido,
  • impotence, or
  • poor visual adaptation to darkness or other changes in vision.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nilandron (Nilutamide) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Nilandron Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Because nilutamide may be used with other medications, the side effects may be due to any one medicine or the combination of medications. Hot flashes, sweating, dizziness, loss of sexual interest/ability, vision changes (such as difficulty seeing when moving into the dark or light, changes in color vision), stomach pain, constipation, nausea, signs of alcohol intolerance (such as flushing, tiredness) dry skin, increased sensitivity to touch/pain, and loss of body hair may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, nilutamide has caused severe (sometimes fatal) liver problems. Seek immediate medical attention if you develop symptoms of liver problems (such as loss of appetite, persistent nausea/vomiting/stomach pain, severe tiredness, dark urine, yellowing eyes/skin). Liver problems can happen at any time while taking nilutamide, but they occur most often during the first 3-4 months of treatment. Your doctor will tell you whether to stop or continue nilutamide. Your doctor will monitor your liver function with blood tests before you start and while you are taking nilutamide. Keep all medical and laboratory appointments.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Nilandron (Nilutamide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nilandron FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse experiences were reported during a multicenter clinical trial comparing NILANDRON (nilutamide) + surgical castration versus placebo + surgical castration. The most frequently reported (greater than 5%) adverse experiences during treatment with NILANDRON (nilutamide) tablets in combination with surgical castration are listed below. For comparison, adverse experiences seen with surgical castration and placebo are also listed.

  NILANDRON + surgical castration
(N=225)
Placebo + surgical castration
(N=232)
Adverse Experience % All % All
Cardiovascular System
  Hypertension 5.3 2.6
Digestive System
  Nausea 9.8 6.0
  Constipation 7.1 3.9
Endocrine System
  Hot flushes 28.4 22.4
Metabolic and Nutritional System
  Increased AST 8.0 3.9
  Increased ALT 7.6 4.3
Nervous System
  Dizziness 7.1 3.4
Respiratory System
  Dyspnea 6.2 7.3
Special Senses
  Impaired adaptation to dark 12.9 1.3
  Abnormal vision 6.7 1.7
Urogenital System
  Urinary tract infection 8.0 9.1

The overall incidence of adverse experiences was 86% (194/225) for the NILANDRON (nilutamide) group and 81% (188/232) for the placebo group.

The following adverse experiences were reported during a multicenter clinical trial comparing NILANDRON (nilutamide) + leuprolide versus placebo + leuprolide. The most frequently reported (greater than 5%) adverse experiences during treatment with NILANDRON (nilutamide) tablets in combination with leuprolide are listed below. For comparison, adverse experiences seen with leuprolide and placebo are also listed.

  NILANDRON + leuprolide
(N=209)
Placebo + leuprolide
(N=202)
Adverse Experience % All % All
Body as a Whole
  Pain 26.8 27.7
  Headache 13.9 10.4
  Asthenia 19.1 20.8
  Back pain 11.5 16.8
  Abdominal pain 10.0 5.4
  Chest pain 7.2 4.5
  Flu syndrome 7.2 3.0
  Fever 5.3 6.4
Cardiovascular System
  Hypertension 9.1 9.9
Digestive System
  Nausea 23.9 8.4
  Constipation 19.6 16.8
  Anorexia 11.0 6.4
  Dyspepsia 6.7 4.5
  Vomiting 5.7 4.0
Endocrine System
  Hot flushes 66.5 59.4
  Impotence 11.0 12.9
  Libido decreased 11.0 4.5
Hemic and Lymphatic System
  Anemia 7.2 6.4
Metabolic and Nutritional System
  Increased AST 12.9 13.9
  Peripheral edema 12.4 17.3
  Increased ALT 9.1 8.9
Musculoskeletal System
  Bone Pain 6.2 5.0
Nervous System
  Insomnia 16.3 15.8
  Dizziness 10.0 11.4
  Depression 8.6 7.4
  Hypesthesia 5.3 2.0
Respiratory System
  Dyspnea 10.5 7.4
  Upper respiratory infection 8.1 10.9
  Pneumonia 5.3 3.5
Skin and Appendages
  Sweating 6.2 3.0
  Body hair loss 5.7 0.5
  Dry skin 5.3 2.5
  Rash 5.3 4.0
Special Senses
  Impaired adaptation to dark 56.9 5.4
  Chromatopsia 8.6 0.0
  Impaired adaptation to light 7.7 1.0
  Abnormal vision 6.2 4.5
Urogenital System
  Testicular atrophy 16.3 12.4

The overall incidence of adverse experiences is 99.5% (208/209) for the NILANDRON (nilutamide) group and 98.5% (199/202) for the placebo group.

Some frequently occurring adverse experiences, for example hot flushes, impotence, and decreased libido, are known to be associated with low serum androgen levels and known to occur with medical or surgical castration alone. Notable was the higher incidence of visual disturbances (variously described as impaired adaptation to darkness, abnormal vision, and colored vision), which led to treatment discontinuation in 1% to 2% of patients.

Interstitial pneumonitis occurred in one ( < 1%) patient receiving NILANDRON (nilutamide) in combination with surgical castration and in seven patients (3%) receiving NILANDRON (nilutamide) in combination with leuprolide and one patient receiving placebo in combination with leuprolide. Overall, it has been reported in 2% of patients receiving NILANDRON (nilutamide) . This included a report of interstitial pneumonitis in 8 of 47 patients (17%) in a small study performed in Japan.

In addition, the following adverse experiences were reported in 2 to 5% of patients treated with NILANDRON (nilutamide) in combination with leuprolide or orchiectomy.

Body as a Whole: Malaise (2%).

Cardiovascular System: Angina (2%), heart failure (3%), syncope (2%).

Digestive System: Diarrhea (2%), gastrointestinal disorder (2%), gastrointestinal hemorrhage (2%), melena (2%).

Metabolic and Nutritional System: Alcohol intolerance (5%), edema (2%), weight loss (2%).

Musculoskeletal System: Arthritis (2%).

Nervous System: Dry mouth (2%), nervousness (2%), paresthesia (3%).

Respiratory System: Cough increased (2%), interstitial lung disease (2%), lung disorder (4%), rhinitis (2%).

Skin and Appendages: Pruritus (2%).

Special Senses: Cataract (2%), photophobia (2%).

Laboratory Values: Haptoglobin increased (2%), leukopenia (3%), alkaline phosphatase increased (3%), BUN increased (2%), creatinine increased (2%), hyperglycemia (4%).

Read the entire FDA prescribing information for Nilandron (Nilutamide) »

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Nilandron - User Reviews

Nilandron User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Nilandron sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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