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Nilutamide Side Effects

The most commonly reported side effects of nilutamide include prostatic specific antigen increased, disease progression, and pain, based on 162 FDA adverse event reports from 2004 to 2023.

Nilutamide side effects

Percentages show how often each reaction appears relative to total reports for nilutamide.

1
Prostatic Specific Antigen Increased16.0%26
2
Disease Progression7.4%12
3
Pain7.4%12
4
Fatigue6.8%11
5
Asthenia6.8%11
6
Prostate Cancer Metastatic6.2%10
7
Arthralgia6.2%10
8
Dyspnoea5.6%9
9
Death5.6%9
10
Malignant Neoplasm Progression5.6%9
11
Dyspnoea5.6%9
12
Insomnia4.9%8
13
Hot Flush4.9%8
14
Dizziness4.9%8
15
Fatigue4.3%7

These are voluntary reports and do not establish that nilutamide caused these reactions.

Report severity

79.6%Serious129 reports
30.2%Hospitalizations49 reports
16.0%Fatal26 reports

Seriousness is determined by the reporter, not by OpenClaim.

Nilutamide drug interactions

Other drugs that appear in adverse event reports alongside nilutamide. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Enzalutamide26.5%43
2
Abiraterone-acetate13.6%22
3
Docetaxel11.1%18
4
Leuprolide11.1%18
5
Bicalutamide11.1%18
6
Zoledronic-acid7.4%12
7
Ketoconazole4.9%8
8
Ciprofloxacin4.9%8
9
Prednisone4.9%8
10
Goserelin4.3%7
11
Denosumab4.3%7
12
Metronidazole4.3%7
13
Triptorelin-pamoate4.3%7
14
Cabazitaxel3.7%6
15
Lenalidomide2.5%4

Taken alongside

1
Leuprolide21.0%34
2
Aspirin16.0%26
3
Bicalutamide13.0%21
4
Prednisone13.0%21
5
Acetaminophen10.5%17
6
Ergocalciferol9.9%16
7
Hydrocodone9.3%15
8
Oxycodone8.6%14
9
Metoprolol8.6%14
10
Amlodipine8.6%14
11
Simvastatin8.6%14
12
Calcium8.6%14
13
Omeprazole8.0%13
14
Furosemide8.0%13
15
Hydrochlorothiazide7.4%12

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports nilutamide side effects

0.6% of nilutamide adverse event reports involve female patients and 95.7% involve male patients. The largest age group is elderly at 84%. These figures reflect who reports side effects, not underlying risk.

Sex

Female0.6%
Male95.7%
Unknown3.7%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6415.9%
65+84.1%

What is nilutamide used for

Conditions and purposes for which patients were taking nilutamide when the adverse event was reported.

Bone CancerHormone TherapyHormone-refractory Prostate CancerImmunosuppressant Drug TherapyNeoplasm MalignantProduct Used For Unknown IndicationProstate CancerProstate Cancer MetastaticProstatic Specific Antigen DecreasedProduct Used For Unknown IndicationProstate Cancer

Nilutamide brand names and reporting trend

Nilutamide is sold under the brand name Nilutamide.

Brand names

Nilutamide98

Quarterly reports (20042023)

2005201020152023

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking nilutamide with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.