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Nilutamide

Generic Name: nilutamide (nih LUTE ah mide)
Brand Name: Nilandron
Physician reviewed nilutamide patient information - includes nilutamide description, dosage and directions.
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Drug Information:
Nilutamide is used to treat prostate cancer that has spread to other parts of the body. Nilutamide is for use in men who have undergone surgical castration. Nilutamide may also be used for purposes not listed in this medication guide. You should not use nilutamide if you have severe liver disease or severe breathing problems. Nilutamide can cause serious lung problems. Call your doctor right away if you have chest pain, wheezing, dry cough, fever, and new or worsening shortness of breath. You should not use nilutamide if you are allergic to it, or if you have: Learn more

Nilutamide Side Effects

Nilutamide Side Effects

In Summary

Commonly reported side effects of nilutamide include: nausea, night blindness, and decreased libido. Other side effects include: chest pain, fever, hemeralopia, visual disturbance, chromatopsia, and loss of body hair. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to nilutamide: oral tablet

Warning

Oral route (Tablet)

Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials of nilutamide. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. A routine chest X-ray should be performed prior to initiating treatment and baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath, and if symptoms occur, nilutamide should be discontinued until it can be determined if the symptoms are drug-related.

Along with its needed effects, nilutamide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nilutamide:

More common

  • Blood in the urine
  • blurred vision
  • chest pain
  • chills
  • cough
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • fever or chills
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • pale skin
  • pounding in the ears
  • runny nose
  • shivering
  • shortness of breath
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • sweating
  • tightness in the chest
  • trouble with sleeping
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • wheezing

Less common

  • Arm, back, or jaw pain
  • blindness
  • bloody, black, or tarry stools
  • change in color vision
  • decreased urine output
  • decreased vision
  • difficulty seeing at night
  • dilated neck veins
  • fainting
  • fast or irregular heartbeat
  • increased cough
  • increased sensitivity of the eyes to sunlight
  • irregular breathing
  • swelling of the face, fingers, feet, or lower legs
  • vomiting of blood or material that looks like coffee grounds
  • weight gain or loss

Some side effects of nilutamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Acid or sour stomach
  • belching
  • body hair loss
  • bone pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in vision
  • decrease in testicle size
  • decreased interest in sexual intercourse
  • depression
  • difficulty having a bowel movement (stool)
  • dizziness
  • dry skin
  • feeling of warmth
  • heartburn
  • inability to have or keep an erection
  • increased urge to urinate during the night
  • indigestion
  • loss in sexual ability, desire, drive, or performance
  • pain
  • rash
  • redness of the face, neck, arms and occasionally, upper chest
  • sleeplessness
  • stomach discomfort, upset, or pain
  • sudden sweating
  • unable to sleep
  • waking to urinate at night

Less common

  • Difficulty with moving
  • dry mouth
  • general feeling of discomfort or illness
  • itching
  • muscle pain or stiffness
  • pain, swelling, or redness in the joints
  • passing of gas

For Healthcare Professionals

Applies to nilutamide: oral tablet

Respiratory

Very common (10% or more): Dyspnea (up to 10.5%)

Common (1% to 10%): Interstitial pneumonitis, lung disorder, upper respiratory infection, pneumonia, increased cough, rhinitis

Postmarketing reports: Interstitial or alveolo-interstitial changes (e.g. pulmonary fibrosis)

Hepatic

Very common (10% or more): Increased AST (up to 12.9%)

Common (1% to 10%): Increased ALT, increased alkaline phosphatase, increased BUN, increased creatinine

Uncommon (0.1% to 1%): Hepatitis

Rare (less than 0.1%): Mixed hepatocellular-fulminant hepatitis

Ocular

Very common (10% or more): Impaired adaptation to dark (up to 57%)

Common (1% to 10%): Chromatopsia, impaired adaptation to light, abnormal vision, cataract, photophobia

Cardiovascular

Common (1% to 10%): Hypertension, angina, heart failure

Frequency not reported: QT prolongation

Hematologic

Common (1% to 10%): Anemia, hematuria, melena, increased haptoglobin, leukopenia

Rare (less than 0.1%): Aplastic anemia

General

The most common adverse events (especially nausea, alcohol intolerance, impairment of dark or light adaptation and dizziness) occur early during treatment and usually lessen after one month following dose reduction.

Endocrine

Very common (10% or more): Hot flushes (up to 66.5%), impotence (up to 11%), decreased libido (up to 11%), gynecomastia (up to 10.5%)

Common (1% to 10%): Sweating, body hair loss

Genitourinary

Very common (10% or more): Testicular atrophy (up to 16.3%)

Common (1% to 10%): Urinary tract infection, urinary tract disorder, nocturia

Other

Very common (10% or more): Pain (up to 26.8%), asthenia (up to 19.1%), peripheral edema (up to 12.4%), alcohol intolerance (up to 10%)

Common (1% to 10%): Chest pain, fever, flu syndrome, malaise, syncope

Nervous system

Very common (10% or more): Headache (up to 13.9%), dizziness (up to 10%)

Common (1% to 10%): Hypesthesia, paresthesia, nervousness

Metabolic

Very common (10% or more): Anorexia (up to 11%)

Common (1% to 10%): Weight loss, hyperglycemia

Musculoskeletal

Very common (10% or more): Back pain (up to 11.5%)

Common (1% to 10%): Bone pain, arthritis

Psychiatric

Very common (10% or more): Insomnia (up to 16.3%)

Common (1% to 10%): Depression

Gastrointestinal

Very common (10% or more): Nausea (up to 23.9%), constipation (up to 19.6%), abdominal pain (up to 10%)

Common (1% to 10%): Dyspepsia, vomiting, diarrhea, gastrointestinal disorder, gastrointestinal hemorrhage, dry mouth

Dermatologic

Common (1% to 10%): Dry skin, rash, pruritus

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Nilutamide (www.drugs.com/mtm/nilutamide.html).