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Medically reviewed by Last updated on Aug 15, 2020.


(ni LOO ta mide)

Index Terms

  • RU-23908

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Nilandron: 150 mg [contains corn starch]

Generic: 150 mg

Brand Names: U.S.

  • Nilandron

Pharmacologic Category

  • Antineoplastic Agent, Antiandrogen


Nilutamide is a nonsteroidal antiandrogen which blocks testosterone effects at the androgen receptor level, preventing androgen response.


Rapid and complete


Hepatic (extensive), forms active metabolites


Urine (62%; <2% as unchanged drug); feces (1% to 7%)

Half-Life Elimination

Terminal: 38 to 59 hours; Metabolites: 59 to 126 hours

Use: Labeled Indications

Prostate cancer, metastatic: Treatment of metastatic prostate cancer (in combination with surgical castration)


Hypersensitivity to nilutamide or any component of the formulation; severe hepatic impairment; severe respiratory insufficiency

Canadian labeling: Additional contraindications (not in US labeling): Use in women and children

Dosing: Adult

Prostate cancer, metastatic: Oral: 300 mg once daily (starting the same day or day after surgical castration) for 30 days, followed by 150 mg once daily. Consider therapy discontinuation in patients with evidence of disease progression.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.


Administer without regard to meals.


Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.

Drug Interactions

Alcohol (Ethyl): Nilutamide may enhance the adverse/toxic effect of Alcohol (Ethyl). Specifically, nilutamide may increase the likelihood of alcohol intolerance (eg, facial flushing, malaise, hypotension). Avoid combination

Choline C 11: Antiandrogens may diminish the therapeutic effect of Choline C 11. Monitor therapy

Indium 111 Capromab Pendetide: Antiandrogens may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Reactions reported from monotherapy and combination therapy.


Endocrine & metabolic: Hot flash (28%)

Ophthalmic: Nocturnal amblyopia (13% to 57%)

1% to 10%:

Cardiovascular: Hypertension (5%), cardiac failure (3%), angina pectoris (2%), edema (2%), syncope (2%)

Central nervous system: Dizziness (7%), paresthesia (3%), malaise (2%), nervousness (2%)

Dermatologic: Pruritus (2%)

Endocrine & metabolic: Hyperglycemia (4%), increased haptoglobin (2%), weight loss (2%)

Gastrointestinal: Nausea (10%), constipation (7%), diarrhea (2%), gastrointestinal hemorrhage (2%), melena (2%), xerostomia (2%)

Hematologic & oncologic: Leukopenia (3%)

Hepatic: Increased serum ALT (8%), increased serum AST (8%), increased serum alkaline phosphatase (3%)

Neuromuscular & skeletal: Arthritis (2%)

Ophthalmic: Visual disturbance (7%), cataract (2%), photophobia (2%)

Renal: Increased blood urea nitrogen (2%), increased serum creatinine (2%)

Respiratory: Dyspnea (6%), cough (2%), interstitial pneumonitis (2%), rhinitis (2%)

Miscellaneous: Alcohol intolerance (5%)

<1%, postmarketing, and/or case reports: Anxiety, aplastic anemia, cold extremities, gynecomastia, headache, hepatic injury, hepatitis, maculopapular rash, palpitations, prolonged QT interval on ECG, urticaria, vomiting, weight gain

ALERT: U.S. Boxed Warning

Interstitial pneumonitis:

Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to nilutamide. A small study in Japanese patients showed that 17% of patients developed interstitial pneumonitis. Reports of interstitial changes, including pulmonary fibrosis that led to hospitalization and death, have been reported rarely in postmarketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased diffusing capacity of lungs for carbon monoxide. Most cases occurred within the first 3 months of treatment with nilutamide, and most reversed with discontinuation of therapy. Perform a routine chest x-ray prior to initiating treatment with nilutamide. Consider baseline pulmonary function tests. Instruct patients to report any new or worsening shortness of breath that they experience while on nilutamide. If symptoms occur, immediately discontinue nilutamide until it can be determined if the symptoms are drug related.


Concerns related to adverse effects:

• Hematologic: Anemia may occur with testosterone suppression; monitor CBC periodically as indicated. Aplastic anemia has been reported (postmarketing case reports).

• Hepatotoxicity: Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in 1% of patients receiving nilutamide in controlled studies. Rare cases of hospitalization or deaths due to severe liver injury have been reported, with the onset of hepatotoxicity usually occurring within first 3 to 4 months of therapy. Monitor transaminases. Signs/symptoms of hepatic dysfunction (nausea/vomiting, abdominal pain, anorexia, fatigue, flu-like symptoms, dark urine, jaundice, and/or right upper quadrant pain) should prompt liver function testing. Discontinue treatment immediately for jaundice or ALT >2 times the upper limit of normal (ULN).

• Interstitial pneumonitis: [US Boxed Warning]: Interstitial pneumonitis has been reported in 2% of patients exposed to nilutamide in controlled studies. An increased incidence has been observed in one small study of Japanese patients. Symptoms typically include exertional dyspnea, cough, chest pain, and fever; interstitial changes (including pulmonary fibrosis) leading to hospitalization and fatalities have been reported (rarely). Most cases occurred within the first 3 months of treatment and most reversed after discontinuation. X-rays showed interstitial or alveolo-interstitial changes; pulmonary function tests revealed a restrictive pattern with decreased DLco. Perform chest x-ray prior to treatment initiation and consider baseline pulmonary function testing. Instruct patients to report new or worsening dyspnea. Discontinue nilutamide immediately if signs and/or symptoms of interstitial pneumonitis are observed until a causal effect can be ruled out.

• Vision effects: A delay in adaptation to dark has been reported; in clinical studies, this was reported by 13% to 57% of patients. The delay ranged from seconds to a few minutes after passing from a light to a dark area. This may not abate with continued treatment although may be alleviated by wearing tinted sunglasses. Caution patients who experience adaptation delay about driving at night or through tunnels.

Disease-related concerns:

• Cardiovascular disease: Androgen-deprivation therapy may increase the risk for cardiovascular disease (Levine, 2010). Androgen deprivation therapy with other antiandrogen agents has resulted in prolongation of the QT/QTc interval (Garnick, 2004); evaluate risk versus benefit in patients with congenital long QT syndrome, heart failure, frequent electrolyte abnormalities, and in patients taking medication known to prolong the QT interval. Correct electrolytes prior to initiation and consider periodic electrolyte and ECG monitoring in patients at risk for QT prolongation.

• Decreased bone mineral density: Prolonged use of antiandrogen therapy is associated with decreased bone mineral density and an increased risk of osteoporosis and fracture (Smith, 2003); alcohol abuse, familial history of osteoporosis, and/or chronic use of drugs capable of decreasing bone mass (eg, corticosteroids) may increase risk. Evaluate risk carefully before initiating therapy.

• Diabetes: Hyperglycemia has been observed; use with caution in diabetic patients and monitor for loss of glucose control.

Special populations:

• Females: Not indicated for use in women.

• Pediatrics: Not indicated for use in pediatric patients.

Other warnings/precautions:

• Antiandrogen withdrawal syndrome: Patients with disease progression while receiving antiandrogen therapy may experience clinical improvement with discontinuation of the antiandrogen.

• Ethanol use: Approximately 5% of patients experience intolerance (facial flushing, hypotension, malaise) when ethanol is combined with nilutamide. Instruct patients to avoid ethanol.

Monitoring Parameters

CBC (periodic), liver function tests (transaminases; at baseline, regularly during the first 4 months of treatment, and then periodically thereafter; more frequently if clinically indicated), electrolytes, serum testosterone, PSA, blood glucose and/or glycosylated hemoglobin (HbA1c) in patients with diabetes; chest x-ray (baseline); consider pulmonary function testing (baseline); bone-mineral density (as clinically indicated in patients at risk of osteoporosis); ECG; signs and symptoms of liver dysfunction; vision changes. If initiating nilutamide in patients who are on warfarin, closely monitor prothrombin time.

Pregnancy Considerations

Animal reproduction studies have not been conducted. Nilutamide is not indicated for use in women.

Patient Education

What is this drug used for?

• It is used to treat prostate cancer.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hot flashes

• Nausea

• Dizziness

• Alopecia

• Decreased sex drive

• Constipation

• Dyspepsia

• Flu-like symptoms

• Lack of appetite

• Osteodynia

• Trouble sleeping

• Hyperhydrosis

• Xeroderma

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Chest pain

• Severe headache

• Vision changes

• Considerable asthenia

• Depression

• Paresthesia

• Dyspnea

• Excessive weight gain

• Swelling of extremities

• Hematemesis

• Melena

• Hepatic impairment

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

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