Last reviewed 2026-04-20 · How we verify

Nilandron (NILUTAMIDE)

Nilandron (Nilutamide) is a small molecule androgen receptor inhibitor originally developed by Concordia Pharms Inc and currently owned by Advanz Pharma. It was FDA approved in 1996 for the treatment of metastatic prostate carcinoma. Nilandron works by blocking the androgen receptor, a protein that helps cancer cells grow. As an off-patent medication, it is available as a generic. Key safety considerations include potential liver toxicity and interactions with other medications.

At a glance

Approved indications

• Metastatic Prostate Carcinoma

Boxed warnings

• 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 subjects showed that 8 of 47 patients (17%) developed interstitial pneumonitis. 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. X-rays showed interstitial or alveolo-interstitial changes, and pulmonary function tests revealed a restrictive pattern with decreased DLco. Most cases occurred within the first 3 months of treatment with Nilutamide Tablets, and most reversed with discontinuation of therapy. A routine chest X-ray should be performed prior to initiating treatment with Nilutamide Tablets. Baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath that they experience while on Nilutamide Tablets. If symptoms occur, Nilutamide Tablets should be immediately discontinued until it can be determined if the symptoms are drug related.

Common side effects

• Hot flushes
• Visual disturbances
• Impotence
• Decreased libido
• Dizziness
• Nausea
• Fatigue
• Headache
• Gynecomastia
• Insomnia
• Edema
• Impaired adaptation to darkness

Serious adverse events

• Interstitial pneumonitis
• Heart failure
• Gastrointestinal hemorrhage
• Melena
• Interstitial lung disease
• Cataract
• Syncope
• Angina
• Photophobia
• Leukopenia

Key clinical trials

• Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer (PHASE2)
• Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery (PHASE2,PHASE3)
• Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (PHASE2,PHASE3)
• Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer (PHASE3)
• RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study) (PHASE2)
• Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients
• Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer (PHASE3)
• Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Nilandron CI brief — competitive landscape report
• Nilandron updates RSS · CI watch RSS
• Advanz portfolio CI