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Darolutamide Side Effects

The most commonly reported side effects of darolutamide include fatigue, hot flush, and death, based on 4,796 FDA adverse event reports from 2019 to 2025.

Darolutamide side effects

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

1
Fatigue15.5%745
2
Hot Flush11.8%568
3
Death8.8%420
4
Asthenia6.5%310
5
Prostatic Specific Antigen Increased4.5%216
6
Arthralgia4.3%208
7
Dizziness4.3%206
8
Diarrhoea4.2%203
9
Product Dose Omission Issue3.9%186
10
Incorrect Dose Administered3.8%183
11
Nausea3.6%172
12
Dyspnoea3.4%162
13
Neuropathy Peripheral3.3%158
14
Pain In Extremity3.2%153
15
Off Label Use3.1%148

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

Report severity

68.5%Serious3,285 reports
21.0%Hospitalizations1,007 reports
12.7%Fatal609 reports

Seriousness is determined by the reporter, not by OpenClaim.

Darolutamide drug interactions

Other drugs that appear in adverse event reports alongside darolutamide. 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
Relugolix25.3%1,214
2
Docetaxel9.3%446
3
Leuprolide3.8%183
4
Enzalutamide1.9%90
5
Abiraterone-acetate1.2%56
6
Degarelix-acetate1.1%51
7
Apalutamide1.0%50
8
Prednisone0.7%33
9
Rosuvastatin0.6%30
10
Denosumab0.6%29
11
Goserelin0.5%23
12
Lutetium0.5%22
13
Bicalutamide0.4%21
14
Apixaban0.4%17
15
Acetaminophen0.3%16

Taken alongside

1
Ergocalciferol7.3%349
2
Atorvastatin-calcium6.7%319
3
Docetaxel6.2%296
4
Aspirin6.1%291
5
Tamsulosin-hydrochloride5.6%267
6
Metoprolol5.5%265
7
Acetaminophen5.2%248
8
Amlodipine5.1%245
9
Leuprolide4.8%228
10
Lisinopril3.5%166
11
Apixaban3.4%163
12
Metformin3.3%158
13
Calcium3.0%145
14
Rosuvastatin2.9%139
15
Losartan-potassium2.8%136

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 darolutamide side effects

0.4% of darolutamide adverse event reports involve female patients and 82.7% involve male patients. The largest age group is elderly at 81%. These figures reflect who reports side effects, not underlying risk.

Sex

Female0.4%
Male82.7%
Unknown16.9%

Age group

< 20.0%
2–11<0.1%
12–170.0%
18–6418.8%
65+81.2%

What is darolutamide used for

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

Antiandrogen TherapyAcute Myeloid LeukaemiaAdenocarcinomaAgranulocytosisAndrogen TherapyAntiandrogen TherapyArthritisAsthmaAtrial FibrillationBreast Cancer MetastaticBladder CancerBone CancerBreast CancerBreast Cancer MetastaticCarcinoid Tumour Of The Prostate

Showing 15 of 91 indications

Darolutamide brand names and reporting trend

Darolutamide is sold under the brand name Nubeqa.

Brand names

Nubeqa562

Quarterly reports (20192025)

20192020202220242025

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

Taking darolutamide with another medication?

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