HIGH-VOLUME · MALE-LED
enzalutamide Side Effects
enzalutamide (also sold as Xtandi) is HIGH-VOLUME in this FAERS book #127 of 524 by FAERS report count. Signature opener: MALE-LED - 1% of sex-coded reports are female (361 F / 54,925 M).
Data updated 2026-05-15
- 57,614
- FAERS reports
FAERS voluntary reports, 2012 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
enzalutamide reporting skew - 1% of sex-coded reports are female (361 F / 54,925 M). Volume band HIGH-VOLUME #127 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for enzalutamide (Xtandi): 57,614 FAERS rows (2012-2025). Top named reactions: FATIGUE, DEATH, MALIGNANT NEOPLASM PROGRESSION. Outcome stamps DEATH-HEAVY · HOSP-MID · MALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2012–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-MID · MALE-LED.
FATIGUE leads 10,159 of 57,614 reports
MALE-LED reporters · age peak 75+
Male-led reporters (99% of sex-coded rows)
Age peak 75+ (18,413 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (11,299 reports, 19.6%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 7,664 |
| MALIGNANT NEOPLASM PROGRESSION | 1,807 |
| FATIGUE | 675 |
| DECREASED APPETITE | 460 |
| ASTHENIA | 449 |
| UNDERDOSE | 398 |
| PROSTATIC SPECIFIC ANTIGEN INCREASED | 364 |
| PROSTATE CANCER | 315 |
| NAUSEA | 304 |
| FALL | 266 |
| PNEUMONIA | 254 |
| MALAISE | 242 |
| DIARRHOEA | 230 |
| BACK PAIN | 219 |
| DIZZINESS | 216 |
| PAIN | 202 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 193 |
| DYSPHAGIA | 190 |
| WEIGHT DECREASED | 182 |
Reactions in Hospitalization Reports
Hospitalization mid-share (10,853, 18.8%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| FATIGUE | 1,274 |
| ASTHENIA | 914 |
| DECREASED APPETITE | 875 |
| FALL | 837 |
| MALIGNANT NEOPLASM PROGRESSION | 816 |
| DEATH | 807 |
| NAUSEA | 629 |
| DIZZINESS | 553 |
| MALAISE | 536 |
| DIARRHOEA | 535 |
| PROSTATIC SPECIFIC ANTIGEN INCREASED | 527 |
| PNEUMONIA | 506 |
| DYSPNOEA | 484 |
| HOSPITALISATION | 484 |
| URINARY TRACT INFECTION | 474 |
| PAIN | 433 |
| VOMITING | 430 |
| BACK PAIN | 426 |
| ANAEMIA | 410 |
| DEHYDRATION | 386 |
How to read enzalutamide FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-MID)
FAERS holds 57,614 voluntary reports linked to enzalutamide (Xtandi), 2012-2025. Death is listed on 11,299 (19.6%). Hospitalization appears on 10,853 (18.8%). Top co-reported indication: Prostate Cancer.
CASELOAD books overweight common drugs and loud reporting cultures; MALE-LED is the page opener, not a per-patient risk.
Read with enzalutamide
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 57,675 FAERS cases (Δ 61 heavier vs enzalutamide); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · MALE-LED.
ABS(total_reports) peer at 58,038 FAERS cases (Δ 424 heavier vs enzalutamide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · MALE-LED.
ABS(total_reports) peer at 58,495 FAERS cases (Δ 881 heavier vs enzalutamide); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · MALE-LED.
ABS(total_reports) peer at 56,567 FAERS cases (Δ 1,047 lighter vs enzalutamide); DEATH-HEAVY · HOSP-MID · MALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · MALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 42.5 pp vs enzalutamide's DEATH-HEAVY): CASELOAD · HOSP-MID.
enzalutamide stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.