Prescription medication · Recombinant Uricase
pegloticase
Also sold as Krystexxa. Krystexxa is used to treat chronic gout in adults.
Data updated 2026-05-15
- 3,350
- FDA reportsLightly reported
- 2
- InteractionsFew interactions
- Rx
- Availability
What the data shows
pegloticase (Krystexxa) is a prescription Recombinant Uricase, among the least-reported drugs the FDA tracks (3,350 FDA reports), with 2 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
pegloticase (Krystexxa) is a prescription Recombinant Uricase. Krystexxa is used to treat chronic gout in adults.
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.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from pegloticase's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of pegloticase's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of pegloticase's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss an infusion, contact your doctor as soon as possible to reschedule.
This is a plain-language summary of pegloticase's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
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 3,350 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for pegloticase, by number of reports
- Gout flare
Gout flare
539 reports
- Increased uric acid in blood
Increased uric acid in blood
378 reports
- Reaction to the infusion
Reaction to the infusion
358 reports
- Treatment not working as well
Treatment not working as well
240 reports
- Difficulty breathing 166
Difficulty breathing
166 reports
- Hives 138
Hives
138 reports
- Feeling sick to your stomach 133
Feeling sick to your stomach
133 reports
- Itching 129
Itching
129 reports
- Skin rash 123
Skin rash
123 reports
- Pain in the chest 112
Pain in the chest
112 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for pegloticase each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where pegloticase sits
pegloticase has more FDA adverse-event reports than 20% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is pegloticase; the line is the median (50th percentile).
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
Reports Mentioning Death
107
3.2% of reports — not proof of cause
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 |
| 7 | URTICARIA | 138 |
| 8 | NAUSEA | 133 |
| 9 | PRURITUS | 129 |
| 10 | RASH | 123 |
| 12 | CHEST PAIN | 112 |
| 13 | PAIN | 106 |
| 14 | DIZZINESS | 105 |
| 15 | ANAPHYLACTIC REACTION | 99 |
| 16 | CHEST DISCOMFORT | 96 |
| 17 | FATIGUE | 93 |
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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 3,350 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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