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Nilutamide Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 13, 2023.

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.

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

Less common

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

Less common

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. 2001;PROD.

2. Cerner Multum, Inc. Australian Product Information.

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.