Nilutamide Side Effects

Brand Names: Nilandron

Please note - some side effects for Nilutamide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Nilutamide - for the Consumer

Nilutamide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nilutamide:

Changes in eyesight; constipation; decreased sexual desire; difficulty sleeping; dizziness; frequent or painful urination; hot flashes; impaired adaptation to darkness; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; cough; dark urine; fatigue; fever; flu-like symptoms (headache, tiredness, muscle aches, sore throat); loss of appetite; nausea; shortness of breath; stomach pain; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Hepatic

Hepatic side effects including increased SGOT (8.0%) and SGPT (7.6%) have been reported. Hepatitis or marked increases in liver enzymes lead to drug discontinuation in 1% of the patients in clinical trials. There has been one death reported following elevated hepatic enzymes.

Respiratory

Because interstitial pneumonitis has been reported at a rate of 17% in one study (n=47) in Japan, the manufacturer recommends extra caution in the treatment of Asian patients.

Respiratory side effects including dyspnea (6.2%) and interstitial pneumonitis (2%) have been reported.

Ocular

Ocular side effects have been reported in up to 57% of patients and have resulted in treatment discontinuation in up to 2% of patients. Ocular side effects have included impaired adaptation to dark (12.9%), abnormal vision (6.7%), and alterations in color vision.

Gastrointestinal

Gastrointestinal side effects including nausea (9.8%) and constipation (7.1%) have been reported.

Genitourinary

Genitourinary side effects including urinary tract infection (8.0%) have been reported.

Nervous system

Nervous system side effects including dizziness (7.1%) have been reported.

Endocrine

Endocrine side effects including hot flushes have been reported.

Cardiovascular

Cardiovascular side effects including hypertension have been reported.

Hematologic

A causal relationship between nilutamide and aplastic anemia has not been established.

Hematologic side effects including isolated cases of aplastic anemia have been reported.

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