Enzalutamide side effects: what 58,425 FDA adverse event reports show

Enzalutamide · Xtandi · 1,125 reaction terms · 173,495 drug–reaction co-reports · data 2026-09-14

Drug class

Androgen Receptor Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Xtandi

openFDA label

Who reports

58,425 reports · 62% serious · 11,360 with death outcome · 1% female

openFDA FAERS counts, all years, deduplication not applied

Used for

XTANDI ® is indicated for the treatment of patients with: • castration-resistant prostate cancer (CRPC) • metastatic castration-sensitive prostate cancer (mCSPC) • non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence.

FDA label, Indications and Usage

What it is

Enzalutamide is an androgen receptor inhibitor.

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 adverse reaction 2Labeled (related wording) 6Likely indication confounding 4Reporting / coding artifact 4Lab value / disease marker 5Not in label — unassessed 19

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
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.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,085 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
Malignant spinal cord compression	25	519.3 280.4–961.5ROR 519.5 · calibrated p 4e-12 ✓	181.7 EB05 129.4 · IC025 +4.7 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Labeled (related wording) related wording	serious n=25	no trial arm names this drug
Arrhythmia induced cardiomyopathy	22	369.9 203.4–672.6ROR 370.1 · calibrated p 6e-11 ✓	156.8 EB05 109.1 · IC025 +4.5 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Not in label — unassessed	serious n=22 · 100% clinician	no trial arm names this drug
Prostatic specific antigen increased	4,344	164.4 158.8–170.3ROR 177.6 · calibrated p 1e-9 ✓	112.5 EB05 109.7 · IC025 +6.7 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 23.9 (22.4–25.6)	Lab value / disease marker	serious PRR 103.3 · 70% consumer	no trial arm names this drug
Hereditary optic atrophy	14	89.9 50.0–161.6ROR 89.9 · calibrated p 2e-6 ✓	65.7 EB05 41.6 · IC025 +3.5 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Not in label — unassessed	serious n=14	no trial arm names this drug
Prostatic specific antigen abnormal	199	84.4 72.3–98.4ROR 84.6 · calibrated p 4e-7 ✓	67.9 EB05 60.3 · IC025 +5.6 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 15.7 (11.9–20.6)	Lab value / disease marker	serious n=134	no trial arm names this drug
Brca1 gene mutation	15	73.6 42.2–128.3ROR 73.6 · calibrated p 5e-6 ✓	56.9 EB05 36.6 · IC025 +3.5 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Not in label — unassessed	serious n=14	no trial arm names this drug
Hormone-refractory prostate cancer	181	65.4 55.8–76.6ROR 65.6 · calibrated p 3e-6 ✓	55.0 EB05 48.6 · IC025 +5.3 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 9.9 (7.7–12.6)	Likely indication confounding shares a disease stem with the indications wording	serious n=180	no trial arm names this drug
Brca2 gene mutation	13	56.0 31.2–100.5ROR 56.0 · calibrated p 3e-5 ✓	45.5 EB05 28.3 · IC025 +3.2 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Not in label — unassessed	serious n=12	no trial arm names this drug
Product size issue	612	46.6 42.9–50.7ROR 47.1 · calibrated p 2e-5 ✓	41.3 EB05 38.6 · IC025 +5.2 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 187.2 (117.2–299.2)	Reporting / coding artifact	serious n=288 · 71% consumer	no trial arm names this drug
Prostate cancer metastatic	312	36.8 32.7–41.3ROR 37.0 · calibrated p 9e-5 ✓	33.3 EB05 30.3 · IC025 +4.8 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 5.9 (5.1–7.0)	Likely indication confounding term in indications; also in warnings	serious n=312	no trial arm names this drug
Prostatic specific antigen decreased	35	36.3 25.7–51.5ROR 36.4 · calibrated p 1e-4 ✓	32.5 EB05 24.4 · IC025 +3.9 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 9.2 (5.3–15.8)	Lab value / disease marker	serious n=20 · 71% consumer	no trial arm names this drug
Prostate cancer recurrent	55	35.2 26.7–46.5ROR 35.3 · calibrated p 1e-4 ✓	31.8 EB05 25.4 · IC025 +4.2 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 5.2 (3.6–7.6)	Likely indication confounding shares a disease stem with the indications wording	serious n=55	no trial arm names this drug
Bladder tamponade	17	21.4 13.1–34.9ROR 21.4 · calibrated p 0.003 ✓	19.7 EB05 12.8 · IC025 +2.9 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Not in label — unassessed	serious n=17	no trial arm names this drug
Malignant neoplasm progression	5,468	20.3 19.8–20.8ROR 22.3 · calibrated p 0.001 ✓	19.3 EB05 18.8 · IC025 +4.2 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 40.0 (37.1–43.1)	Reporting / coding artifact	serious PRR 18.3	no trial arm names this drug
Foreign body in respiratory tract	70	20.0 15.7–25.4ROR 20.0 · calibrated p 0.002 ✓	18.9 EB05 15.4 · IC025 +3.7 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Not in label — unassessed	serious n=34 · 74% consumer	no trial arm names this drug
Metastases to bladder	15	19.9 11.8–33.5ROR 19.9 · calibrated p 0.004 ✓	18.3 EB05 11.4 · IC025 +2.7 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Not in label — unassessed	serious n=15	no trial arm names this drug
Hot flush (hot flashes)	3,882	19.4 18.8–20.1ROR 20.8 · calibrated p 0.002 ✓	18.5 EB05 18.0 · IC025 +4.2 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 27.0 (25.0–29.1)	Labeled adverse reaction exact term	serious PRR 17.1 · 87% consumer	no trial arm names this drug
Nephrostomy	16	18.4 11.1–30.4ROR 18.4 · calibrated p 0.005 ✓	16.9 EB05 10.6 · IC025 +2.7 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Not in label — unassessed	serious n=16	no trial arm names this drug
Cancer pain	120	17.6 14.6–21.1ROR 17.6 · calibrated p 0.004 ✓	16.7 EB05 14.3 · IC025 +3.7 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 15.4 (10.9–21.8)	Labeled (related wording) related wording	serious n=118	no trial arm names this drug
Blood testosterone increased	82	14.1 11.3–17.6ROR 14.2 · calibrated p 0.010 ✓	13.5 EB05 11.2 · IC025 +3.3 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 7.3 (5.2–10.1)	Lab value / disease marker	serious n=47	no trial arm names this drug
Retroperitoneal lymphadenopathy	20	14.1 9.0–22.1ROR 14.1 · calibrated p 0.013 ✓	12.9 EB05 8.4 · IC025 +2.6 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 4.6 (2.5–8.3)	Not in label — unassessed	serious n=19	no trial arm names this drug
Blood testosterone abnormal	42	14.0 10.3–19.0ROR 14.0 · calibrated p 0.011 ✓	13.2 EB05 10.0 · IC025 +3.0 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 8.0 (5.0–12.8)	Lab value / disease marker	serious n=28	no trial arm names this drug
Foreign body in throat	112	13.7 11.3–16.5ROR 13.7 · calibrated p 0.011 ✓	13.1 EB05 11.2 · IC025 +3.3 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Not in label — unassessed	serious n=112 · 89% consumer	no trial arm names this drug
Metastases to pelvis	23	13.5 8.9–20.5ROR 13.5 · calibrated p 0.014 ✓	12.5 EB05 8.3 · IC025 +2.7 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 12.7 (6.0–26.6)	Not in label — unassessed	serious n=23	no trial arm names this drug
Prostatic pain	15	13.5 8.0–22.6ROR 13.5 · calibrated p 0.016 ✓	11.9 EB05 7.0 · IC025 +2.4 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Likely indication confounding shares a disease stem with the indications wording	serious n=11	no trial arm names this drug
Hydroureter	13	12.9 7.4–22.4ROR 12.9 · calibrated p 0.020 ✓	11.0 EB05 6.2 · IC025 +2.2 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 5.1 (2.4–10.9)	Not in label — unassessed	serious n=13	no trial arm names this drug
Metastases to bone	548	12.4 11.4–13.5ROR 12.5 · calibrated p 0.014 ✓	12.0 EB05 11.2 · IC025 +3.4 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 6.5 (5.7–7.3)	Not in label — unassessed	serious PRR 11.3	no trial arm names this drug
Oncologic complication	31	11.8 8.2–16.8ROR 11.8 · calibrated p 0.022 ✓	10.9 EB05 7.8 · IC025 +2.7 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Reporting / coding artifact	serious n=31 · 100% consumer	no trial arm names this drug
Bladder obstruction	16	11.8 7.2–19.4ROR 11.8 · calibrated p 0.025 ✓	10.2 EB05 6.2 · IC025 +2.3 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Not in label — unassessed	serious n=16	no trial arm names this drug
Oesophageal ulcer haemorrhage	16	11.6 7.1–19.2ROR 11.7 · calibrated p 0.026 ✓	10.1 EB05 6.1 · IC025 +2.3 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 5.9 (2.9–11.9)	Not in label — unassessed	serious n=16	no trial arm names this drug
Testicular atrophy	26	11.0 7.5–16.3ROR 11.0 · calibrated p 0.028 ✓	10.0 EB05 6.9 · IC025 +2.5 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 8.4 (4.6–15.5)	Not in label — unassessed	serious n=18 · 100% consumer	no trial arm names this drug
Haemorrhage urinary tract	73	10.6 8.4–13.4ROR 10.6 · calibrated p 0.028 ✓	10.1 EB05 8.2 · IC025 +2.9 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 20.1 (12.3–33.0)	Labeled (related wording) related wording	serious n=70 · 82% consumer	no trial arm names this drug
Underdose	2,084	10.5 10.1–11.0ROR 10.9 · calibrated p 0.024 ✓	10.2 EB05 9.9 · IC025 +3.3 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 122.1 (99.3–150.1)	Reporting / coding artifact	serious PRR 18.9 · 78% consumer	no trial arm names this drug
Bone cancer metastatic	15	10.5 6.3–17.5ROR 10.5 · calibrated p 0.038 ✓	8.8 EB05 5.3 · IC025 +2.1 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Labeled (related wording) related wording	serious n=15	no trial arm names this drug
Metastases to spine	94	10.3 8.4–12.7ROR 10.3 · calibrated p 0.030 ✓	9.9 EB05 8.2 · IC025 +2.9 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 8.0 (5.8–10.9)	Not in label — unassessed	serious n=94	no trial arm names this drug
Nipple pain	51	9.2 7.0–12.1ROR 9.2 · calibrated p 0.047 ✓	8.6 EB05 6.7 · IC025 +2.6 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 15.6 (9.1–26.7)	Not in label — unassessed	serious n=24 · 88% consumer	no trial arm names this drug
Radiation injury	26	9.0 6.1–13.2ROR 9.0 · calibrated p 0.055	8.0 EB05 5.6 · IC025 +2.3 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 8.9 (4.8–16.7)	Not in label — unassessed	serious n=24 · 73% consumer	no trial arm names this drug
Spinal cord compression	94	8.8 7.2–10.8ROR 8.8 · calibrated p 0.051	8.4 EB05 7.0 · IC025 +2.7 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 11.5 (8.1–16.4)	Labeled adverse reaction exact term	serious n=93	no trial arm names this drug
Spinal cord neoplasm	21	8.8 5.7–13.5ROR 8.8 · calibrated p 0.060	7.6 EB05 5.1 · IC025 +2.1 3/3 methods agree vs other Androgen Receptor Inhibitors: only this drug	Labeled (related wording) related wording	serious n=21	no trial arm names this drug
Urinary bladder haemorrhage	50	8.7 6.6–11.5ROR 8.7 · calibrated p 0.056	8.1 EB05 6.3 · IC025 +2.5 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 14.5 (8.5–24.6)	Labeled (related wording) related wording	serious n=50 · 74% consumer	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Enzalutamide (searched ENZALUTAMIDE).

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)	10,267	4.8 4.7–4.9ROR 5.6 · calibrated p 0.178	4.7 EB05 4.7 · IC025 +2.2 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 42.6 (40.3–45.0)	Labeled adverse reaction exact term	serious PRR 3.7 · 80% consumer	no trial arm names this drug
Death	7,698	3.2 3.2–3.3ROR 3.6 · calibrated p 0.469	3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 42.7 (40.0–45.5)	Outcome field, not a reaction	serious PRR 3.0	no trial arm names this drug
Malignant neoplasm progression	5,468	20.3 19.8–20.8ROR 22.3 · calibrated p 0.001 ✓	19.3 EB05 18.8 · IC025 +4.2 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 40.0 (37.1–43.1)	Reporting / coding artifact	serious PRR 18.3	no trial arm names this drug
Prostatic specific antigen increased	4,344	164.4 158.8–170.3ROR 177.6 · calibrated p 1e-9 ✓	112.5 EB05 109.7 · IC025 +6.7 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 23.9 (22.4–25.6)	Lab value / disease marker	serious PRR 103.3 · 70% consumer	no trial arm names this drug
Asthenia (weakness)	4,171	4.0 3.9–4.1ROR 4.2 · calibrated p 0.335	4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 28.4 (26.4–30.6)	Labeled adverse reaction exact term	serious PRR 3.1 · 77% consumer	no trial arm names this drug
Drug ineffective (drug did not work)	4,052	1.1 1.1–1.1ROR 1.1 · calibrated p 0.381	1.1 EB05 1.1 · IC025 +0.1 vs other Androgen Receptor Inhibitors: PRR 36.6 (33.7–39.9)	Reporting / coding artifact	serious PRR 1.2 · 76% consumer	no trial arm names this drug
Hot flush (hot flashes)	3,882	19.4 18.8–20.1ROR 20.8 · calibrated p 0.002 ✓	18.5 EB05 18.0 · IC025 +4.2 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 27.0 (25.0–29.1)	Labeled adverse reaction exact term	serious PRR 17.1 · 87% consumer	no trial arm names this drug
Decreased appetite (loss of appetite)	3,408	5.3 5.2–5.5ROR 5.6 · calibrated p 0.178	5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 36.7 (33.4–40.2)	Labeled adverse reaction exact term	serious PRR 4.6 · 76% consumer	no trial arm names this drug
Nausea	3,259	1.5 1.4–1.5ROR 1.5 · calibrated p 0.650	1.5 EB05 1.4 · IC025 +0.5 vs other Androgen Receptor Inhibitors: PRR 31.9 (29.2–34.8)	Labeled adverse reaction exact term	serious PRR 1.4 · 76% consumer	no trial arm names this drug
Dizziness	3,143	2.3 2.2–2.4ROR 2.3 · calibrated p 0.882	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 29.7 (27.3–32.5)	Labeled adverse reaction exact term	serious PRR 1.9 · 80% consumer	no trial arm names this drug
Diarrhoea (diarrhea)	2,798	1.6 1.5–1.6ROR 1.6 · calibrated p 0.701	1.6 EB05 1.5 · IC025 +0.6 vs other Androgen Receptor Inhibitors: PRR 29.2 (26.7–32.1)	Labeled adverse reaction exact term	serious PRR 1.2 · 80% consumer	no trial arm names this drug
Back pain	2,298	3.6 3.4–3.7ROR 3.7 · calibrated p 0.443	3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 31.6 (28.5–35.2)	Labeled adverse reaction exact term	serious PRR 3.0 · 79% consumer	no trial arm names this drug
Arthralgia (joint pain)	2,152	1.9 1.8–1.9ROR 1.9 · calibrated p 0.889	1.9 EB05 1.8 · IC025 +0.8 vs other Androgen Receptor Inhibitors: PRR 31.4 (28.1–34.9)	Labeled adverse reaction exact term	serious PRR 1.6 · 81% consumer	no trial arm names this drug
Underdose	2,084	10.5 10.1–11.0ROR 10.9 · calibrated p 0.024 ✓	10.2 EB05 9.9 · IC025 +3.3 3/3 methods agree vs other Androgen Receptor Inhibitors: PRR 122.1 (99.3–150.1)	Reporting / coding artifact	serious PRR 18.9 · 78% consumer	no trial arm names this drug
Fall	1,834	2.0 1.9–2.1ROR 2.0 · calibrated p 0.953	2.0 EB05 1.9 · IC025 +0.9 vs other Androgen Receptor Inhibitors: PRR 23.9 (21.5–26.5)	Labeled adverse reaction exact term	serious PRR 1.9	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.

Arrhythmia induced cardiomyopathy — n=22, PRR 369.9
Foreign body in respiratory tract — n=70, PRR 20.0
Retroperitoneal lymphadenopathy — n=20, PRR 14.1
Foreign body in throat — n=112, PRR 13.7
Metastases to pelvis — n=23, PRR 13.5
Metastases to bone — n=548, PRR 12.4
Testicular atrophy — n=26, PRR 11.0
Metastases to spine — n=94, PRR 10.3
Nipple pain — n=51, PRR 9.2
Radiation injury — n=26, PRR 9.0

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 Enzalutamide?

In FDA FAERS, the most frequently co-reported reaction terms for Enzalutamide are fatigue, prostatic specific antigen increased, asthenia, hot flush, decreased appetite, nausea. 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 Enzalutamide have an FDA boxed warning?

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

Do FAERS signals prove that Enzalutamide 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 b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf, effective 20260728; matched on openfda.generic_name.exact:"ENZALUTAMIDE")
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, 1,125 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 ENZALUTAMIDE, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.