pegloticase
Brand names: Krystexxa
Krystexxa is a medicine used to treat chronic gout in adults when other treatments don't work well enough. It helps lower uric acid levels in your blood.
What it does
Krystexxa is used to treat chronic gout in adults.
Common side effects
Gout flares, Nausea, Infusion reactions
Key warnings
Krystexxa can cause serious allergic reactions, including anaphylaxis, during or after the infusion.
How It Works
Krystexxa contains an enzyme that breaks down uric acid in your body. This helps to lower the amount of uric acid in your blood. Lowering uric acid can reduce gout symptoms.
How to Take It
Krystexxa is given as an intravenous (IV) infusion every two weeks. The usual dose is 8 mg. You will also likely take methotrexate 15 mg weekly. Your doctor will monitor your uric acid levels before each infusion.
Pregnancy & Breastfeeding
It is not known if Krystexxa can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if Krystexxa passes into breast milk, so it should not be used when breastfeeding unless the benefit outweighs the risk.
Missed Dose
If you miss an infusion, contact your doctor as soon as possible to reschedule.
Storage
Store Krystexxa in the refrigerator between 36°F to 46°F and protect it from light; do not freeze or shake.
Side Effects (from patient reports)
Based on 2,350 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 3,350 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2011–2025.
Total Reports
3,350
Death-Related Reports
107
Hospitalization Reports
610
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | GOUT | 539 |
| 2 | BLOOD URIC ACID INCREASED | 378 |
| 3 | INFUSION RELATED REACTION | 358 |
| 4 | THERAPEUTIC RESPONSE DECREASED | 240 |
| 5 | DYSPNOEA | 166 |
| 6 | DRUG INEFFECTIVE | 146 |
| 7 | URTICARIA | 138 |
| 8 | NAUSEA | 133 |
| 9 | PRURITUS | 129 |
| 10 | RASH | 123 |
| 11 | OFF LABEL USE | 119 |
| 12 | CHEST PAIN | 112 |
| 13 | PAIN | 106 |
| 14 | DIZZINESS | 105 |
| 15 | ANAPHYLACTIC REACTION | 99 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Krystexxa can cause serious allergic reactions, including anaphylaxis, during or after the infusion. You should receive Krystexxa in a healthcare setting where anaphylaxis can be treated. If you have G6PD deficiency, you should not take Krystexxa, as it can cause red blood cell problems.
Known Drug Interactions
( 7.2 ) Pegloticase: Discontinue and refrain from initiating treatment with allopurinol tablets. Pegloticase Clinical Impact Concomitant use of allopurinol tablets and pegloticase may potentially blunt the rise of serum uric acid levels and increase the risk of pegloticase related anaphylaxis in patients whose uric acid level increase to above 6 mg/dL. Intervention Discontinue and do not institute allopurinol tablets therapy during treatment with pegloticase.
Mechanism: Allopurinol can hide changes in your blood levels that warn doctors of a possible severe allergic reaction to pegloticase.
What to do: Stop taking allopurinol before starting pegloticase and do not take it again while you are on treatment.
7 DRUG INTERACTIONS 7.1 Methotrexate KRYSTEXXA 8 mg every 2 weeks has been studied in patients with chronic gout refractory to conventional therapy taking concomitant oral methotrexate 15 mg weekly [see Clinical Studies (14) ] . Co-administration of methotrexate with KRYSTEXXA may increase pegloticase concentration compared to KRYSTEXXA alone [see Clinical Pharmacology (12.3) ] .
Mechanism: Taking methotrexate along with pegloticase can cause the levels of pegloticase to stay higher in your blood than usual.
What to do: Your healthcare provider will monitor your treatment to ensure the combination is working safely.
Common Questions
What should I do before starting Krystexxa?
How often will I receive Krystexxa?
Will I need any other medications with Krystexxa?
What should I do if I experience an infusion reaction?
How will my doctor monitor my treatment?
Can Krystexxa cause allergic reactions?
What is G6PD deficiency?
Can I take Krystexxa if I have kidney problems?
What if my uric acid levels go above 6 mg/dL?
Will I get medicine before my infusion?
What are the common side effects of pegloticase?
Does pegloticase interact with other medications?
What drug class is pegloticase?
Is pegloticase safe during pregnancy?
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What the FDA Data Shows for pegloticase
The FDA label for pegloticase (sold under brand names such as Krystexxa) classifies it as a prescription-only medication in the Recombinant Uricase class. Krystexxa is used to treat chronic gout in adults. Official labeling lists 11 commonly reported side effects, including Gout flares, Nausea, Infusion reactions.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,350 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: August 29, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages