Nilutamide Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 6, 2025.

Applies to nilutamide: oral tablet.

Important warnings This medicine can cause some serious health issues

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.

Serious side effects of nilutamide

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 side effects

• 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 side effects

• 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

Other side effects of nilutamide

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 side effects

• 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 side effects

• 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.

General adverse events

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]

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]

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]

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]

Further information

Nilutamide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer