What the label lists and what reports show
Pegaspargase side effects
Pegaspargase's FDA label: “The most common (>5%) grade > 3 adverse reactions with ONCASPAR are hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events …” FAERS holds 12,172 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (1,584 reports).
- No generic listed
Check it at the source: the pegaspargase FDA label on DailyMed (effective October 7, 2024, Servier Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common (>5%) grade > 3 adverse reactions with ONCASPAR are hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections.
Table 2. Incidence of Selected Grades 3 and 4 Adverse Reactions in Study CCG-1962
| Reaction | ONCASPAR (n=58) | Native E. coli L-Asparaginase (n=59) |
|---|---|---|
| Infection | 3 (5%) | 3 (5%) |
| Abnormal Liver Tests | 3 (5%) | 5 (8%) |
| Elevated Transaminases Aspartate aminotransferase, alanine aminotransferase. | 2 (3%) | 4 (7%) |
| Hyperbilirubinemia | 1 (2%) | 1 (2%) |
| Hyperglycemia | 3 (5%) | 2 (3%) |
| Central Nervous System Thrombosis | 2 (3%) | 2 (3%) |
| Coagulopathy Prolonged prothrombin time or partial thromboplastin time; or… | 1 (2%) | 3 (5%) |
| Pancreatitis | 1 (2%) | 1 (2%) |
| Allergic Reactions to Asparaginase | 1 (2%) | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and serious hypersensitivity reactions [see Warnings and Precautions (5.1) ] Thrombosis [see Warnings and Precautions (5.2) ] Pancreatitis [see Warnings and Precautions (5.3) ] Glucose intolerance [see Warnings and Precautions (5.4) ] Hemorrhage [see Warnings and Precautions (5.5) ] Hepatotoxicity, including VOD [see Warnings and Precautions (5.6) ] The most common (>5%) grade > 3 adverse reactions with ONCASPAR are hypoalbuminemia, elevated transaminase, febrile neutropenia, hypertriglyceridemia, hyperglycemia, bilirubin increased, pancreatitis, abnormal clotting studies, embolic and thrombotic events, hypersensitivity, sepsis, and infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Servier Pharmaceuticals, at 1-800-807-6124 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, BLA103411 (Sigma Tau), as published by Servier Pharmaceuticals LLC, effective October 7, 2024 (SPL set ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce), via openFDA; the full label on DailyMed
What do FAERS reports show?
12,172 reports list pegaspargase among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,557 are coded as a death and 7,468 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (2,817, against a median of 810 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 23 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pegaspargase: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions