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.
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
Gout
539 reports
- Blood Uric Acid Increased
Blood Uric Acid Increased
378 reports
- Infusion Related Reaction
Infusion Related Reaction
358 reports
- Therapeutic Response Decreased
Therapeutic Response Decreased
240 reports
- Dyspnoea 166
Dyspnoea
166 reports
- Urticaria 138
Urticaria
138 reports
- Nausea 133
Nausea
133 reports
- Pruritus 129
Pruritus
129 reports
- Rash 123
Rash
123 reports
- Chest Pain 112
Chest Pain
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) 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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for pegloticase?
Related Medications in Recombinant Uricase
Other drugs grouped near pegloticase - same-class peers and common alternatives.
abatacept
Orencia
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acetaminophen
Tylenol
Acetaminophen (Tylenol) is a medicine that can relieve pain and reduce fever.
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acetaminophen/hydrocodone
Vicodin, Norco
This medicine contains acetaminophen and hydrocodone.
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acetaminophen/oxycodone
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Percocet is a strong pain medicine.
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adalimumab
Humira
Idacio is a medicine that blocks a protein called TNF.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for pegloticase: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 3,350.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 3.19%.
- azelastine Δ 0.06 pts · 16,672 reports · Antihistamine (Nasal) 3.13%death share
- netarsudil Δ 0.08 pts · 1,797 reports · Rho Kinase Inhibitor (Ophthalmic) 3.12%death share
- guanfacine Δ 0.11 pts · 7,386 reports · Central Alpha-2 Agonist 3.09%death share
- conjugated estrogens Δ 0.11 pts · 57,675 reports · Conjugated Estrogen 3.08%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: August 29, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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