LOW-VOLUME · MALE-LED
pegloticase Side Effects
pegloticase (also sold as Krystexxa) is a LOW-VOLUME FAERS extract #419 of 524 by FAERS report count. Still opens on MALE-LED: 19% of sex-coded reports are female (412 F / 1,722 M).
Data updated 2026-05-15
- 3,350
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
pegloticase reporting skew - 19% of sex-coded reports are female (412 F / 1,722 M). Volume band LOW-VOLUME #419 of 524 by FAERS report count; caseload SIGNAL.
Thinner FAERS extract for pegloticase (Krystexxa) (3,350 reports #419 of 524 by FAERS report count). 19% of sex-coded reports are female (412 F / 1,722 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2011–2025). Stamps SIGNAL · DEATH-MARKED · HOSP-MID · MALE-LED.
GOUT leads 539 of 3,350 reports
MALE-LED reporters · age peak 45-64
Male-led reporters (81% of sex-coded rows)
Age peak 45-64 (614 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 107 reports (3.2% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 53 |
| GOUT | 9 |
| MYOCARDIAL INFARCTION | 7 |
| CARDIAC ARREST | 6 |
| SEPSIS | 5 |
| ASTHENIA | 4 |
| CARDIAC FAILURE CONGESTIVE | 4 |
| FALL | 4 |
| MALAISE | 4 |
| PAIN | 4 |
| CARDIAC DISORDER | 3 |
| DYSPNOEA | 3 |
| HYPOTENSION | 3 |
| LOSS OF CONSCIOUSNESS | 3 |
| NECROTISING FASCIITIS | 3 |
| OSTEOMYELITIS | 3 |
| RENAL FAILURE | 3 |
| RESPIRATORY FAILURE | 3 |
| ACUTE KIDNEY INJURY | 2 |
| ARTHRALGIA | 2 |
Reactions in Hospitalization Reports
Hospitalization mid-share (610, 18.2%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| GOUT | 100 |
| DYSPNOEA | 57 |
| INFUSION RELATED REACTION | 47 |
| CHEST PAIN | 41 |
| ANAPHYLACTIC REACTION | 35 |
| DIZZINESS | 34 |
| PAIN | 30 |
| ARTHRALGIA | 29 |
| NAUSEA | 29 |
| VOMITING | 29 |
| ASTHENIA | 27 |
| HYPOTENSION | 26 |
| THERAPEUTIC RESPONSE DECREASED | 25 |
| CARDIAC FAILURE CONGESTIVE | 24 |
| LOSS OF CONSCIOUSNESS | 23 |
| MYOCARDIAL INFARCTION | 23 |
| PNEUMONIA | 23 |
| BLOOD GLUCOSE INCREASED | 22 |
| BLOOD URIC ACID INCREASED | 22 |
| PAIN IN EXTREMITY | 22 |
How to read pegloticase FAERS figures (SIGNAL · DEATH-MARKED · HOSP-MID)
FAERS holds 3,350 voluntary reports linked to pegloticase (Krystexxa), 2011-2025. Death is listed on 107 (3.2%). Hospitalization appears on 610 (18.2%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and MALE-LED skew still differ by drug; not a complete safety profile.
Read with pegloticase
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-MID stamps.
ABS(total_reports) peer at 3,344 FAERS cases (Δ 6 lighter vs pegloticase); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-MARKED · HOSP-MID · MALE-LED.
ABS(total_reports) peer at 3,330 FAERS cases (Δ 20 lighter vs pegloticase); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-MARKED · HOSP-MID · MALE-LED.
ABS(total_reports) peer at 3,393 FAERS cases (Δ 43 heavier vs pegloticase); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-MARKED · HOSP-MID · MALE-LED.
ABS(total_reports) peer at 3,396 FAERS cases (Δ 46 heavier vs pegloticase); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's SIGNAL · DEATH-MARKED · HOSP-MID · MALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 58.9 pp vs pegloticase's DEATH-MARKED): CASELOAD · HOSP-MID.
pegloticase stamps SIGNAL · MALE-LED; class peers and methodology beat restating the same FAERS caveats on every effects URL.