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Bicalutamide Side Effects

The most commonly reported side effects of bicalutamide include fatigue, death, and prostatic specific antigen increased, based on 15,511 FDA adverse event reports from 2004 to 2025. 3.6% of reports found the drug to be ineffective.

Bicalutamide side effects

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

1
Fatigue7.9%1,224
2
Death5.8%900
3
Prostatic Specific Antigen Increased5.3%820
4
Hot Flush4.7%725
5
Asthenia4.5%701
6
Malignant Neoplasm Progression4.4%676
7
Prostate Cancer3.8%589
8
Drug Ineffective3.6%551
9
Nausea3.4%521
10
Dizziness3.3%518
11
Diarrhoea3.0%467
12
Decreased Appetite3.0%461
13
Dyspnoea2.8%433
14
Off Label Use2.7%418
15
Anaemia2.6%408

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

Report severity

83.1%Serious12,888 reports
36.4%Hospitalizations5,639 reports
17.9%Fatal2,769 reports

Seriousness is determined by the reporter, not by OpenClaim.

Bicalutamide drug interactions

Other drugs that appear in adverse event reports alongside bicalutamide. 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
Leuprolide21.0%3,250
2
Enzalutamide13.8%2,136
3
Abiraterone-acetate7.1%1,109
4
Goserelin6.8%1,060
5
Docetaxel4.6%710
6
Zoledronic-acid3.9%611
7
Prednisone2.8%442
8
Denosumab2.8%434
9
Relugolix2.3%355
10
Triptorelin-pamoate2.2%337
11
Degarelix-acetate1.7%258
12
Apalutamide1.2%190
13
Cabazitaxel1.1%177
14
Lenalidomide1.0%155
15
Tamsulosin-hydrochloride1.0%148

Taken alongside

1
Aspirin12.1%1,884
2
Tamsulosin-hydrochloride10.3%1,599
3
Leuprolide9.6%1,488
4
Amlodipine8.7%1,354
5
Atorvastatin-calcium8.7%1,350
6
Acetaminophen8.0%1,247
7
Prednisone7.4%1,144
8
Furosemide7.0%1,083
9
Metoprolol6.8%1,054
10
Ergocalciferol6.7%1,042
11
Metformin5.5%849
12
Calcium5.4%842
13
Omeprazole5.4%832
14
Simvastatin5.3%829
15
Lisinopril5.2%814

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 bicalutamide side effects

1.2% of bicalutamide adverse event reports involve female patients and 92.0% involve male patients. The largest age group is elderly at 84%. These figures reflect who reports side effects, not underlying risk.

Sex

Female1.2%
Male92.0%
Unknown6.9%

Age group

< 2<0.1%
2–11<0.1%
12–170.2%
18–6415.6%
65+84.1%

What is bicalutamide used for

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

AdenocarcinomaAdenocarcinoma Of Salivary GlandAdjuvant TherapyAdverse EventAlopeciaAndrogen DeficiencyAndrogen TherapyAndrogens IncreasedAnti-androgen Withdrawal SyndromeAntiandrogen TherapyAnticoagulant TherapyArthritisAsthmaAbnormal BehaviourAdenocarcinoma

Showing 15 of 233 indications

Bicalutamide brand names and reporting trend

Bicalutamide is sold under the brand name Bicalutamide.

Brand names

Bicalutamide9,519

Quarterly reports (20042025)

20052010201520202025

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

Taking bicalutamide with another medication?

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