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Nilandron

Last reviewed on RxList: 5/30/2019
Nilandron Side Effects Center

Last reviewed on RxList 5/30/2019

Nilandron (nilutamide) is an antiandrogen that works in the body to prevent the actions of androgens (male hormones) and is used in the treatment of prostate cancer. Common side effects of Nilandron include:

  • hot flashes
  • sweating
  • dizziness
  • loss of sexual interest/ability
  • impotence
  • 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
  • loss of body hair
  • nausea
  • vomiting
  • skin rash, or
  • loss of appetite

Because Nilandron may be used with other medications, the side effects may be due to any one medicine or the combination of medications. Tell your doctor if you have serious side effects of Nilandron including:

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

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.

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Nilandron Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • chest pain, wheezing, dry cough, fever;
  • new or worsening shortness of breath;
  • flu symptoms, pale skin, feeling tired; or
  • liver problems--nausea, vomiting, loss of appetite, right-sided upper stomach pain, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • hot flashes;
  • dizziness;
  • constipation;
  • nausea or vomiting, loss of appetite;
  • skin rash;
  • decreased libido, impotence; or
  • vision changes.

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.

Read the entire detailed patient monograph for Nilandron (Nilutamide)

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Nilandron Professional Information

SIDE EFFECTS

Clinical Trial Experience

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

Adverse Experience NILANDRON + surgical castration
(N=225) % All
Placebo + surgical castration
(N=232) % 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 group and 81% (188/232) for the placebo group.

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

Adverse Experience NILANDRON + leuprolide
(N=209) % All
Placebo +leuprolide
(N=202) % 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
  Gynecomastia 10.5 11.9
  Urinary tract infection 8.6 21.3
  Hematuria 8.1 7.9
  Urinary tract disorder 7.2 10.4
  Nocturia 6.7 6.4

The overall incidence of adverse experiences is 99.5% (208/209) for the NILANDRON 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 in combination with surgical castration and in seven patients (3%) receiving NILANDRON in combination with leuprolide and one patient receiving placebo in combination with leuprolide. Overall, it has been reported in 2% of patients receiving NILANDRON. 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 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%).

To report SUSPECTED ADVERSE REACTIONS, contact Concordia Pharmaceuticals Inc. at 1-877- 370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Nilandron (Nilutamide)

Related Resources for Nilandron

Read the Nilandron User Reviews »

© Nilandron Patient Information is supplied by Cerner Multum, Inc. and Nilandron Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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