Nilutamide Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 21, 2024.

Applies to nilutamide: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have shortness of breath, difficulty with breathing, or chest pain while you are using this medicine.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: clay-colored stools; dark urine; fever; headache; loss of appetite; nausea or vomiting; pain or tenderness in the upper right side of the stomach; unusual tiredness or weakness; or yellow eyes or skin.

Drinking alcoholic beverages while taking nilutamide may cause unwanted effects in some people. Possible effects include feeling dizzy or lightheaded when getting up from a lying or sitting position suddenly; having flu-like symptoms; or flushing of the face. If you notice any of these effects, avoid drinking alcohol while you are taking this medicine.

Be very careful while driving, especially at night or when you drive into or out of tunnels. Nilutamide can temporarily change the way your eyes react to light. You may not be able to see as well as usual for several minutes after going from bright light to darkness. Wearing eyeglasses with tinted lenses may help reduce these effects.

Serious side effects of nilutamide

Along with its needed effects, nilutamide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nilutamide:

Other side effects of nilutamide

Some side effects of nilutamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to nilutamide: oral tablet.

General adverse events

The most common adverse events (especially nausea, alcohol intolerance, impairment of dark or light adaptation and dizziness) occur early during treatment and usually lessen after one month following dose reduction.^[Ref]

Hepatic

• Very common (10% or more): Increased AST (up to 12.9%)
• Common (1% to 10%): Increased ALT, increased alkaline phosphatase, increased BUN, increased creatinine
• Uncommon (0.1% to 1%): Hepatitis
• Rare (less than 0.1%): Mixed hepatocellular-fulminant hepatitis^[Ref]

Ocular

• Very common (10% or more): Impaired adaptation to dark (up to 57%)
• Common (1% to 10%): Chromatopsia, impaired adaptation to light, abnormal vision, cataract, photophobia^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, angina, heart failure
• Frequency not reported: QT prolongation^[Ref]

Hematologic

• Common (1% to 10%): Anemia, hematuria, melena, increased haptoglobin, leukopenia
• Rare (less than 0.1%): Aplastic anemia^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (up to 10.5%)
• Common (1% to 10%): Interstitial pneumonitis, lung disorder, upper respiratory infection, pneumonia, increased cough, rhinitis
• Postmarketing reports: Interstitial or alveolo-interstitial changes (e.g. pulmonary fibrosis)^[Ref]

Endocrine

• Very common (10% or more): Hot flushes (up to 66.5%), impotence (up to 11%), decreased libido (up to 11%), gynecomastia (up to 10.5%)
• Common (1% to 10%): Sweating, body hair loss^[Ref]

Genitourinary

• Very common (10% or more): Testicular atrophy (up to 16.3%)
• Common (1% to 10%): Urinary tract infection, urinary tract disorder, nocturia^[Ref]

Other

• Very common (10% or more): Pain (up to 26.8%), asthenia (up to 19.1%), peripheral edema (up to 12.4%), alcohol intolerance (up to 10%)
• Common (1% to 10%): Chest pain, fever, flu syndrome, malaise, syncope^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 13.9%), dizziness (up to 10%)
• Common (1% to 10%): Hypesthesia, paresthesia, nervousness^[Ref]

Metabolic

• Very common (10% or more): Anorexia (up to 11%)
• Common (1% to 10%): Weight loss, hyperglycemia^[Ref]

Musculoskeletal

• Very common (10% or more): Back pain (up to 11.5%)
• Common (1% to 10%): Bone pain, arthritis^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (up to 16.3%)
• Common (1% to 10%): Depression^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 23.9%), constipation (up to 19.6%), abdominal pain (up to 10%)
• Common (1% to 10%): Dyspepsia, vomiting, diarrhea, gastrointestinal disorder, gastrointestinal hemorrhage, dry mouth^[Ref]

Dermatologic

• Common (1% to 10%): Dry skin, rash, pruritus^[Ref]

See also:

Further information

Nilutamide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer