Substance / Medication

Nilutamide

Overview

Active Ingredient
nilutamide
RxNorm CUI
31805

Indications

Metastatic Prostate Cancer 2 Nilutamide tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D).For maximum benefit, Nilutamide treatment must begin on the same day as or on the day after surgical castration.

Labeler: Prasco LaboratoriesUpdated: 2025-12-12T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

If symptoms occur, Nilutamide should be immediately discontinued until it can be determined if the symptoms are drug related. Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials in patients exposed to nilutamide. A small study in Japanese subjects showed that 8

Contraindications

When this intervention should not be used

Nilutamide tablets are contraindicated:• in patients with severe hepatic impairment (baseline hepatic enzymes should be evaluated prior to treatment)• in patients with severe respiratory insufficiency• in patients with hypersensitivity to nilutamide or any component of this preparation.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Research Evidence

Published studies and systematic reviews

Sort:
Efficacy of nilutamide as secondary hormonal therapy in androgen-independent prostate cancer.
Nakabayashi Mari, Regan Meredith M, Lifsey Deborah et al. · BJU Int · 2005
PMID: 16153200Observational
Reduction of nilutamide by NO synthases: implications for the adverse effects of this nitroaromatic antiandrogen drug.
Ask K, Dijols S, Giroud C et al. · Chem Res Toxicol · 2003
PMID: 14680368Observational
Lung caught in Nilutamide treatment.
Lourenço Eva Patrícia, Nzwalo Hipólito, Sampaio Mário Rui et al. · BMJ Case Rep · 2016
PMID: 27599808Case ReportFull text (PMC)
Fulminant hepatic failure due to nilutamide hepatotoxicity.
Merwat Shehzad N, Kabbani Wareef, Adler Douglas G · Dig Dis Sci · 2009
PMID: 18688719Case Report
Delayed dark adaptation caused by nilutamide.
Chan Patrick, Odel Jeffrey G · J Neuroophthalmol · 2008
PMID: 18562852Case Report
[Fatal fulminating hepatitis induced by nilutamide].
Edouard André, Robinel Roselyne, Rat Christel et al. · Gastroenterol Clin Biol · 2003
PMID: 14770126Case Report
Nilutamide-induced neutropenia.
Eaton V S, Blackmore T K · BJU Int · 2001
PMID: 11890258Case Report

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Nilutamide (substance)
SNOMED CT
96372005
UMLS CUI
C0068771
RxNorm CUI
31805
Labeler
Prasco Laboratories

Clinical Data

This intervention maps to 2 entities in the Healos knowledge graph.

2
Conditions
0
Biomarkers
0
Specialists
0
Symptoms

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.