Nilutamide Side Effects

It is possible that some side effects of nilutamide may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to nilutamide: oral tablet

As well as its needed effects, nilutamide may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking nilutamide, check with your doctor immediately:

More common
  • Blood in the urine
  • blurred vision
  • chest pain
  • chills
  • cough
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • fever or chills
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • pale skin
  • pounding in the ears
  • runny nose
  • shivering
  • shortness of breath
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • sweating
  • tightness in the chest
  • trouble with sleeping
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • wheezing
Less common
  • Arm, back, or jaw pain
  • blindness
  • bloody, black, or tarry stools
  • change in color vision
  • decreased urine output
  • decreased vision
  • difficulty seeing at night
  • dilated neck veins
  • fainting
  • fast or irregular heartbeat
  • increased cough
  • increased sensitivity of the eyes to sunlight
  • irregular breathing
  • swelling of the face, fingers, feet, or lower legs
  • vomiting of blood or material that looks like coffee grounds
  • weight gain or loss

Some nilutamide side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Acid or sour stomach
  • belching
  • body hair loss
  • bone pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in vision
  • decrease in testicle size
  • decreased interest in sexual intercourse
  • depression
  • difficulty having a bowel movement (stool)
  • dizziness
  • dry skin
  • feeling of warmth
  • heartburn
  • inability to have or keep an erection
  • increased urge to urinate during the night
  • indigestion
  • loss in sexual ability, desire, drive, or performance
  • pain
  • rash
  • redness of the face, neck, arms and occasionally, upper chest
  • sleeplessness
  • stomach discomfort, upset, or pain
  • sudden sweating
  • unable to sleep
  • waking to urinate at night
Less common
  • Difficulty with moving
  • dry mouth
  • general feeling of discomfort or illness
  • itching
  • muscle pain or stiffness
  • pain, swelling, or redness in the joints
  • passing of gas

For Healthcare Professionals

Applies to nilutamide: oral tablet

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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