Bicalutamide side effects: what 15,150 FDA adverse event reports show

Bicalutamide · 1,110 reaction terms · 54,380 drug–reaction co-reports · data 2026-09-14

Drug class

Androgen Receptor Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Who reports

15,150 reports · 83% serious · 2,714 with death outcome · 1% female

openFDA FAERS counts, all years, deduplication not applied

Used for

1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments .

FDA label, Indications and Usage

What it is

11. DESCRIPTION Bicalutamide Tablets USP contain 50 mg of bicalutamide USP, a non-steroidal androgen receptor inhibitor with no other known endocrine activity.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled (related wording) 3Likely indication confounding 4Lab value / disease marker 9Not in label — unassessed 24

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,070 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Central nervous system mass	50	1,624.8 1,078.4–2,448.2ROR 1,630.2 · χ² 36,305 / p <1e-300	577.3 EB05 455.1 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=50	no trial arm names this drug
Wall motion score index abnormal	50	1,156.7 793.8–1,685.3ROR 1,160.5 · χ² 30,627 / p <1e-300	504.9 EB05 398.0 · IC025 +6.0 3/3 methods agree	Lab value / disease marker	serious n=50	no trial arm names this drug
Airway remodelling	50	934.8 652.6–1,339.2ROR 937.9 · χ² 27,130 / p <1e-300	457.6 EB05 360.7 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=50	no trial arm names this drug
Polyneuropathy in malignant disease	17	362.5 212.4–618.7ROR 362.9 · χ² 4,561 / p <1e-300	217.0 EB05 143.5 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Neuroendocrine carcinoma of prostate	12	315.0 168.2–589.9ROR 315.2 · χ² 2,802 / p <1e-300	182.3 EB05 111.1 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious n=11	no trial arm names this drug
Atopy	50	303.3 223.3–411.9ROR 304.3 · χ² 12,080 / p <1e-300	226.9 EB05 178.8 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=50	no trial arm names this drug
Hormone-dependent prostate cancer	11	263.4 138.2–502.2ROR 263.6 · χ² 2,195 / p <1e-300	160.1 EB05 95.4 · IC025 +3.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=11	no trial arm names this drug
Prostate cancer recurrent	58	144.5 110.3–189.3ROR 145.0 · χ² 7,343 / p <1e-300	125.4 EB05 100.6 · IC025 +5.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=57	no trial arm names this drug
Prostate cancer metastatic	289	130.7 115.9–147.3ROR 133.2 · χ² 33,822 / p <1e-300	118.4 EB05 107.4 · IC025 +6.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=288	no trial arm names this drug
Hormone-refractory prostate cancer	101	130.4 106.4–159.9ROR 131.3 · χ² 11,722 / p <1e-300	116.6 EB05 98.7 · IC025 +5.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=101	no trial arm names this drug
Drug name confusion	11	129.4 69.8–240.1ROR 129.5 · χ² 1,166 / p 9e-256	98.6 EB05 58.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	–	no trial arm names this drug
Eosinophilic myocarditis	50	101.7 76.3–135.5ROR 102.0 · χ² 4,547 / p <1e-300	91.5 EB05 72.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=50	no trial arm names this drug
Prostatic specific antigen increased	939	100.7 94.4–107.3ROR 107.2 · χ² 86,245 / p <1e-300	93.6 EB05 88.7 · IC025 +6.4 3/3 methods agree	Lab value / disease marker	serious PRR 85.9	no trial arm names this drug
Prostatic specific antigen abnormal	70	99.3 78.0–126.5ROR 99.8 · χ² 6,259 / p <1e-300	90.4 EB05 74.0 · IC025 +5.4 3/3 methods agree	Lab value / disease marker	serious n=47	no trial arm names this drug
Cardiac septal defect	48	98.2 73.3–131.6ROR 98.5 · χ² 4,219 / p <1e-300	88.6 EB05 69.5 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=48	no trial arm names this drug
Metastases to nervous system	11	89.9 48.9–165.4ROR 90.0 · χ² 826 / p 7e-182	74.0 EB05 44.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Cystitis radiation	11	83.9 45.6–154.2ROR 83.9 · χ² 772 / p 3e-170	69.9 EB05 41.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Prostatic specific antigen decreased	21	81.0 52.1–125.7ROR 81.1 · χ² 1,491 / p <1e-300	71.7 EB05 49.5 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious n=12	no trial arm names this drug
Breast cancer male	28	79.9 54.6–117.0ROR 80.1 · χ² 1,988 / p <1e-300	72.0 EB05 52.3 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious n=27	no trial arm names this drug
Microangiopathy	50	78.2 58.8–103.9ROR 78.4 · χ² 3,530 / p <1e-300	72.0 EB05 56.8 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=50	no trial arm names this drug
Metastases to soft tissue	13	72.4 41.5–126.5ROR 72.5 · χ² 803 / p 6e-177	62.8 EB05 39.0 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Retroperitoneal lymphadenopathy	24	66.0 43.9–99.4ROR 66.1 · χ² 1,405 / p <1e-300	60.2 EB05 42.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=24	no trial arm names this drug
Pituitary haemorrhage	12	55.0 30.9–97.9ROR 55.0 · χ² 560 / p 4e-124	49.0 EB05 29.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Hydroureter	14	53.7 31.5–91.5ROR 53.7 · χ² 647 / p 6e-143	48.5 EB05 30.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Oesophageal ulcer haemorrhage	15	42.1 25.2–70.4ROR 42.2 · χ² 545 / p 8e-121	39.0 EB05 25.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Primary sequestrum	27	41.9 28.6–61.5ROR 42.0 · χ² 1,007 / p 3e-221	39.7 EB05 28.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=27	no trial arm names this drug
Blood testosterone increased	62	40.9 31.8–52.7ROR 41.1 · χ² 2,307 / p <1e-300	39.3 EB05 31.8 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=40	no trial arm names this drug
Aortic calcification	16	38.5 23.4–63.3ROR 38.6 · χ² 533 / p 4e-118	36.0 EB05 23.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Metastases to bone	429	37.3 33.9–41.0ROR 38.3 · χ² 14,711 / p <1e-300	36.2 EB05 33.5 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 25.3	no trial arm names this drug
Blood testosterone abnormal	29	36.9 25.5–53.3ROR 36.9 · χ² 950 / p 6e-209	35.2 EB05 25.7 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious n=11	no trial arm names this drug
Eosinophilic granulomatosis with polyangiitis	50	35.1 26.5–46.5ROR 35.2 · χ² 1,583 / p <1e-300	33.9 EB05 26.7 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=50	no trial arm names this drug
Blood chromogranin a increased	11	34.2 18.8–62.2ROR 34.2 · χ² 314 / p 1e-70	31.7 EB05 18.8 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious n=11	no trial arm names this drug
Bone debridement	11	31.9 17.5–57.9ROR 31.9 · χ² 292 / p 9e-66	29.7 EB05 17.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Soft tissue mass	10	30.6 16.4–57.3ROR 30.6 · χ² 252 / p 5e-57	28.4 EB05 16.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Osteosclerosis	33	29.6 20.9–41.7ROR 29.6 · χ² 863 / p 4e-190	28.5 EB05 21.3 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=33	no trial arm names this drug
Blood immunoglobulin e increased	50	29.0 21.9–38.3ROR 29.1 · χ² 1,295 / p 6e-284	28.1 EB05 22.2 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious n=50	no trial arm names this drug
Eosinophil count decreased	46	27.9 20.9–37.4ROR 28.0 · χ² 1,144 / p 5e-251	27.1 EB05 21.1 · IC025 +3.9 3/3 methods agree	Lab value / disease marker	serious n=46	no trial arm names this drug
Testicular atrophy	17	27.6 17.1–44.5ROR 27.6 · χ² 401 / p 2e-89	26.3 EB05 17.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Metastases to spine	65	27.4 21.4–35.0ROR 27.5 · χ² 1,593 / p <1e-300	26.7 EB05 21.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=64	no trial arm names this drug
Respiratory symptom	54	27.2 20.8–35.6ROR 27.3 · χ² 1,310 / p 4e-287	26.5 EB05 21.0 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious n=54	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Bicalutamide only as a background or rescue medication (NCT00002651, NCT00936390); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Fatigue (tiredness)	1,328	2.4 2.2–2.5ROR 2.5 · χ² 1,087 / p 1e-238	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.9	no trial arm names this drug
Death	993	1.6 1.5–1.7ROR 1.6 · χ² 230 / p 3e-52	1.6 EB05 1.5 · IC025 +0.6	Outcome field, not a reaction	serious PRR 1.1	no trial arm names this drug
Prostatic specific antigen increased	939	100.7 94.4–107.3ROR 107.2 · χ² 86,245 / p <1e-300	93.6 EB05 88.7 · IC025 +6.4 3/3 methods agree	Lab value / disease marker	serious PRR 85.9	no trial arm names this drug
Asthenia (weakness)	809	3.0 2.8–3.2ROR 3.1 · χ² 1,081 / p 2e-237	3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.4	no trial arm names this drug
Hot flush (hot flashes)	793	14.7 13.7–15.7ROR 15.5 · χ² 10,044 / p <1e-300	14.6 EB05 13.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.8 · 72% consumer	no trial arm names this drug
Prostate cancer	754	13.0 12.1–13.9ROR 13.6 · χ² 8,266 / p <1e-300	12.8 EB05 12.1 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.8	no trial arm names this drug
Malignant neoplasm progression	719	9.8 9.2–10.6ROR 10.3 · χ² 5,683 / p <1e-300	9.7 EB05 9.2 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9	no trial arm names this drug
Drug ineffective (drug did not work)	609	0.6 0.6–0.7ROR 0.6 · χ² 131 / p 1e-30	0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.9	no trial arm names this drug
Dizziness	582	1.6 1.5–1.8ROR 1.6 · χ² 140 / p 1e-32	1.6 EB05 1.5 · IC025 +0.6	Labeled adverse reaction exact term	serious PRR 1.5	no trial arm names this drug
Nausea	563	1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.391	1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.0	no trial arm names this drug
Dyspnoea (shortness of breath)	541	1.3 1.2–1.4ROR 1.3 · χ² 44 / p 2e-11	1.3 EB05 1.2 · IC025 +0.3	Labeled adverse reaction exact term	serious PRR 1.1	no trial arm names this drug
Diarrhoea (diarrhea)	527	1.1 1.0–1.2ROR 1.1 · χ² 8 / p 0.002	1.1 EB05 1.1 · IC025 +0.0	Labeled adverse reaction exact term	serious PRR 1.0	no trial arm names this drug
Decreased appetite (loss of appetite)	512	3.1 2.8–3.3ROR 3.1 · χ² 716 / p 4e-158	3.1 EB05 2.8 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 2.7	no trial arm names this drug
Anaemia (low red blood cells)	500	3.6 3.3–4.0ROR 3.7 · χ² 958 / p 1e-210	3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.7	no trial arm names this drug
Metastases to bone	429	37.3 33.9–41.0ROR 38.3 · χ² 14,711 / p <1e-300	36.2 EB05 33.5 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 25.3	no trial arm names this drug

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Central nervous system mass — n=50, PRR 1,624.8
Airway remodelling — n=50, PRR 934.8
Atopy — n=50, PRR 303.3
Eosinophilic myocarditis — n=50, PRR 101.7
Cardiac septal defect — n=48, PRR 98.2
Microangiopathy — n=50, PRR 78.2
Retroperitoneal lymphadenopathy — n=24, PRR 66.0
Primary sequestrum — n=27, PRR 41.9
Metastases to bone — n=429, PRR 37.3
Eosinophilic granulomatosis with polyangiitis — n=50, PRR 35.1

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Bicalutamide?

In FDA FAERS, the most frequently co-reported reaction terms for Bicalutamide are fatigue, prostatic specific antigen increased, asthenia, hot flush, prostate cancer, dizziness. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Bicalutamide have an FDA boxed warning?

No. The FDA label retrieved for Bicalutamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Bicalutamide causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 7a08d88b-051a-4c16-9560-12685c500c58, effective 20260227; matched on openfda.generic_name.exact:"BICALUTAMIDE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,110 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query BICALUTAMIDE, results-bearing studies sorted by enrollment)

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.