Nilandron Side Effects

Generic Name: nilutamide

Please note - some side effects for Nilandron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nilandron - for the Consumer

Nilandron

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 Nilandron:

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.

Nilandron Side Effects - for the Professional

Nilandron

The following adverse experiences were reported during a multicenter clinical trial comparing Nilandron + surgical castration versus placebo + surgical castration. The most frequently reported (greater than 5%) adverse experiences during treatment with Nilandron tablets in combination with surgical castration are listed below. For comparison, adverse experiences seen with surgical castration and placebo are also listed.

The overall incidence of adverse experiences was 86% (194/225) for the Nilandron group and 81% (188/232) for the placebo group.

The following adverse experiences were reported during a multicenter clinical trial comparing Nilandron + leuprolide versus placebo + leuprolide. The most frequently reported (greater than 5%) adverse experiences during treatment with Nilandron tablets in combination with leuprolide are listed below. For comparison, adverse experiences seen with leuprolide and placebo are also listed.

The overall incidence of adverse experiences is 99.5% (208/209) for the Nilandron group and 98.5% (199/202) for the placebo group.

Some frequently occurring adverse experiences, for example hot flushes, impotence, and decreased libido, are known to be associated with low serum androgen levels and known to occur with medical or surgical castration alone. Notable was the higher incidence of visual disturbances (variously described as impaired adaptation to darkness, abnormal vision, and colored vision), which led to treatment discontinuation in 1% to 2% of patients.

Interstitial pneumonitis occurred in one (<1%) patient receiving Nilandron in combination with surgical castration and in seven patients (3%) receiving Nilandron in combination with leuprolide and one patient receiving placebo in combination with leuprolide. Overall, it has been reported in 2% of patients receiving Nilandron. This included a report of interstitial pneumonitis in 8 of 47 patients (17%) in a small study performed in Japan.

In addition, the following adverse experiences were reported in 2 to 5% of patients treated with Nilandron in combination with leuprolide or orchiectomy.

Body as a Whole: Malaise (2%).

Cardiovascular System: Angina (2%), heart failure (3%), syncope (2%).

Digestive System: Diarrhea (2%), gastrointestinal disorder (2%), gastrointestinal hemorrhage (2%), melena (2%).

Metabolic and Nutritional System: Alcohol intolerance (5%), edema (2%), weight loss (2%).

Musculoskeletal System: Arthritis (2%).

Nervous System: Dry mouth (2%), nervousness (2%), paresthesia (3%).

Respiratory System: Cough increased (2%), interstitial lung disease (2%), lung disorder (4%), rhinitis (2%).

Skin and Appendages: Pruritus (2%).

Special Senses: Cataract (2%), photophobia (2%).

Laboratory Values: Haptoglobin increased (2%), leukopenia (3%), alkaline phosphatase increased (3%), BUN increased (2%), creatinine increased (2%), hyperglycemia (4%).

Side Effects by Body System

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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