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Nilutamide Side Effects

Medically reviewed by Last updated on Jan 31, 2022.


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


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.

Side effects requiring immediate medical attention

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

Side effects not requiring immediate medical attention

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


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)[Ref]


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[Ref]


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[Ref]


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

Frequency not reported: QT prolongation[Ref]


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

Rare (less than 0.1%): Aplastic anemia[Ref]


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.[Ref]


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[Ref]


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

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


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[Ref]

Nervous system

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

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


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

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


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

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


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

Common (1% to 10%): Depression[Ref]


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[Ref]


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


1. "Product Information. Nilandron (nilutamide)." Hoechst Marion Roussel (2001):

2. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.