Pegaspargase: adverse event reports filed with FDA

6,294

reports as suspect product

0% of all reports · about 297 a year

259

reports, 12 months to June 2026

322 in the 12 months before

99.5%

marked serious by the reporter

97.7% across the class

12.1%

record death among outcomes, as reported

759 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Pegaspargase reports recording the termmedian drug in asparagine-specific enzyme

1. Febrile neutropeniafever with low white blood cells13.6%857
2. Febrile bone marrow aplasia8.4%528
3. Pyrexiafever5.3%333
4. Sepsisa severe body-wide response to infection4.8%304
5. Hypertriglyceridaemia3.8%239
6. Neutropenialow neutrophils, a type of white blood cell3.8%237
7. Hypofibrinogenaemia3.5%223
8. Off label useused for a purpose or in a way not on the label3.5%222
9. Hyperbilirubinaemia3.5%220
10. Thrombocytopenialow platelets3.2%200
11. Mucosal inflammation3.1%196
12. Myelosuppression3%190
13. Pancreatitisinflammation of the pancreas3%189
14. Bacterial infectiona bacterial infection2.8%179
15. Vomitingbeing sick2.7%168
16. Abdominal painstomach or belly pain2.5%160
17. Pneumonialung infection2.5%159
18. Viral infectiona viral infection2.4%154
19. Pseudomonal sepsis2.4%153
20. Product use in unapproved indicationused for a purpose not on the label2.4%152
21. Anaemialow red blood cells2.4%150
22. Clostridium difficile colitisa bowel infection with C. difficile2.2%141
23. Alanine aminotransferase increasedraised liver enzyme (ALT)2.2%139
24. Bronchopulmonary aspergillosis2.2%137
25. Septic shockshock arising from infection2.1%132
26. Deaththe patient died; cause not stated by this term2.1%131
27. Secondary immunodeficiency2.1%130
28. Mycobacterium chelonae infection2%125
29. Nauseafeeling sick2%123
30. Aspergillus infection1.9%118

Top 30 of 839 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the asparagine-specific enzyme class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 12,068 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 26.4% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 6,294 reports.

Drugs most often listed in the same reports

Other products listed in reports where Pegaspargase is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the asparagine-specific enzyme class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Pegaspargase as a suspect or interacting product; reports listing it only as a concomitant medication (547) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.