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Pegloticase Side Effects

The most commonly reported side effects of pegloticase include gout, blood uric acid increased, and infusion related reaction, based on 3,499 FDA adverse event reports from 2011 to 2025. 4.3% of reports found the drug to be ineffective.

Pegloticase side effects

Percentages show how often each reaction appears relative to total reports for pegloticase.

1
Gout15.5%543
2
Blood Uric Acid Increased10.7%376
3
Infusion Related Reaction10.7%374
4
Therapeutic Response Decreased7.3%257
5
Dyspnoea4.7%164
6
Drug Ineffective4.3%152
7
Urticaria3.9%138
8
Nausea3.8%133
9
Pruritus3.6%127
10
Rash3.5%123
11
Off Label Use3.4%119
12
Chest Pain3.2%112
13
Dizziness3.0%106
14
Pain3.0%106
15
Anaphylactic Reaction2.9%101

These are voluntary reports and do not establish that pegloticase caused these reactions.

Report severity

45.0%Serious1,576 reports
17.8%Hospitalizations622 reports
3.1%Fatal108 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pegloticase drug interactions

Other drugs that appear in adverse event reports alongside pegloticase. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Methotrexate5.9%205
2
Mycophenolate3.0%105
3
Methylprednisolone1.0%34
4
Prednisone0.9%32
5
Diphenhydramine0.5%18
6
Corticotropin0.5%18
7
Colchicine0.3%12
8
Allopurinol0.3%12
9
Acetaminophen0.2%7
10
Febuxostat0.2%7
11
Leflunomide0.2%7
12
Hydrocortisone0.2%6
13
Adalimumab0.2%6
14
Tacrolimus0.1%5
15
Dexamethasone0.1%5

Taken alongside

1
Methylprednisolone11.0%384
2
Diphenhydramine10.4%363
3
Acetaminophen9.9%348
4
Colchicine8.9%311
5
Prednisone8.3%290
6
Allopurinol3.7%129
7
Methotrexate3.6%127
8
Folic-acid3.1%107
9
Amlodipine3.0%105
10
Lisinopril2.9%101
11
Aspirin2.8%98
12
Fexofenadine-hydrochloride2.8%97
13
Metoprolol2.7%96
14
Atorvastatin-calcium2.7%93
15
Febuxostat2.6%91

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports pegloticase side effects

12.3% of pegloticase adverse event reports involve female patients and 52.4% involve male patients. The largest age group is adult at 69%. These figures reflect who reports side effects, not underlying risk.

Sex

Female12.3%
Male52.4%
Unknown35.4%

Age group

< 2<0.1%
2–110.1%
12–17<0.1%
18–6468.7%
65+31.0%

What is pegloticase used for

Conditions and purposes for which patients were taking pegloticase when the adverse event was reported.

ArthritisArthropathyAtrial FibrillationAtrophyArthralgiaBlood Uric Acid AbnormalBlood Uric Acid IncreasedBlood Uric AcidBlood Uric Acid IncreasedCalcinosisChronic DiseaseChronic Kidney DiseaseDrug Use For Unknown IndicationEar InfectionGout

Showing 15 of 38 indications

Pegloticase brand names and reporting trend

Pegloticase is sold under the brand name Krystexxa.

Brand names

Krystexxa127

Quarterly reports (20112025)

20122016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking pegloticase with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.