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Apalutamide Side Effects

The most commonly reported side effects of apalutamide include rash, death, and fatigue, based on 10,988 FDA adverse event reports from 2014 to 2025. 2.2% of reports found the drug to be ineffective.

Apalutamide side effects

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

1
Rash10.8%1,186
2
Death10.4%1,147
3
Fatigue10.0%1,095
4
Hot Flush7.5%821
5
Product Dose Omission Issue3.9%430
6
Asthenia3.7%407
7
Diarrhoea3.5%386
8
Off Label Use3.2%347
9
Dizziness3.1%346
10
Arthralgia3.0%332
11
Fall2.9%316
12
Decreased Appetite2.7%298
13
Prostatic Specific Antigen Increased2.7%293
14
Incorrect Dose Administered2.5%278
15
Pruritus2.3%253

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

Report severity

61.7%Serious6,784 reports
21.9%Hospitalizations2,411 reports
13.3%Fatal1,457 reports

Seriousness is determined by the reporter, not by OpenClaim.

Apalutamide drug interactions

Other drugs that appear in adverse event reports alongside apalutamide. 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
Relugolix7.5%829
2
Leuprolide3.6%395
3
Abiraterone-acetate2.6%286
4
Prednisone1.8%201
5
Degarelix-acetate1.4%150
6
Enzalutamide1.0%110
7
Triptorelin-pamoate0.8%84
8
Gallium0.7%74
9
Docetaxel0.6%70
10
Goserelin0.6%68
11
Bicalutamide0.6%61
12
Lutetium0.5%60
13
Darolutamide0.5%52
14
Denosumab0.4%41
15
Apixaban0.3%30

Taken alongside

1
Atorvastatin-calcium5.0%548
2
Leuprolide4.9%537
3
Aspirin4.9%536
4
Tamsulosin-hydrochloride4.5%499
5
Ergocalciferol4.3%468
6
Amlodipine4.2%464
7
Acetaminophen3.4%370
8
Metformin3.0%330
9
Metoprolol2.9%320
10
Lisinopril2.9%319
11
Rosuvastatin2.5%272
12
Losartan-potassium2.1%234
13
Calcium2.1%231
14
Levothyroxine-sodium1.9%211
15
Hydrochlorothiazide1.9%207

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 apalutamide side effects

0.4% of apalutamide adverse event reports involve female patients and 84.9% involve male patients. The largest age group is elderly at 89%. These figures reflect who reports side effects, not underlying risk.

Sex

Female0.4%
Male84.9%
Unknown14.6%

Age group

< 2<0.1%
2–11<0.1%
12–170.0%
18–6411.1%
65+88.8%

What is apalutamide used for

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

Acquired Growth Hormone ResistanceAccidental Exposure To ProductAdenocarcinomaAdenocarcinoma GastricAdjuvant TherapyAdverse Drug ReactionAntiandrogen TherapyBladder CancerBone CancerBone DisorderBreast CancerBenign Prostatic HyperplasiaBladder CancerBone CancerBone Cancer Metastatic

Showing 15 of 87 indications

Apalutamide brand names and reporting trend

Apalutamide is sold under the brand name Apalutamide.

Brand names

Apalutamide1,477

Quarterly reports (20142025)

2014202020242025

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

Taking apalutamide with another medication?

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