pegloticase Side Effects
Also known as: Krystexxa
Analysis of 3,350 adverse event reports submitted to the FDA from 2011 to 2025.
Total Reports
3,350
Death-Related
107
3.2% of reports
Hospitalizations
610
18.2% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 107 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| 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
Top reactions in 610 reports where hospitalization was an outcome.
| 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 |
Nearby — Related Medications
What the FAERS Data Reveals About pegloticase Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 3,350 voluntary reports linked to pegloticase and its brand equivalents (Krystexxa), spanning 2011 through 2025. Of those, 107 (3.2%) listed death as an outcome and 610 (18.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 19% were female and 80% male; age distribution skews toward 45-64, with 614 reports in that bracket. The single most reported reaction is gout with 539 submissions, followed by blood uric acid increased and infusion related reaction.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.