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Nilutamide Side Effects

It is possible that some side effects of nilutamide may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to nilutamide: oral tablet

As well as its needed effects, nilutamide may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking nilutamide, check with your doctor immediately:

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 nilutamide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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)[Ref]

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[Ref]

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[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, angina, heart failure
Frequency not reported: QT prolongation[Ref]

Hematologic

Common (1% to 10%): Anemia, hematuria, melena, increased haptoglobin, leukopenia
Rare (less than 0.1%): Aplastic anemia[Ref]

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.[Ref]

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[Ref]

Genitourinary

Very common (10% or more): Testicular atrophy (up to 16.3%)
Common (1% to 10%): Urinary tract infection, urinary tract disorder, nocturia[Ref]

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[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]

Metabolic

Very common (10% or more): Anorexia (up to 11%)
Common (1% to 10%): Weight loss, hyperglycemia[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 11.5%)
Common (1% to 10%): Bone pain, arthritis[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 16.3%)
Common (1% to 10%): Depression[Ref]

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[Ref]

Dermatologic

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

References

1. "Product Information. Nilandron (nilutamide)." Hoechst Marion-Roussel Inc, Kansas City, MO.

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

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