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Asparaginase Side Effects

The most commonly reported side effects of asparaginase include febrile neutropenia, off label use, and neutropenia, based on 10,168 FDA adverse event reports from 2004 to 2025. 2.9% of reports found the drug to be ineffective.

Asparaginase side effects

Percentages show how often each reaction appears relative to total reports for asparaginase.

1
Febrile Neutropenia9.2%936
2
Off Label Use3.9%400
3
Neutropenia3.9%393
4
Pyrexia3.7%373
5
Sepsis3.4%345
6
Bacterial Infection2.9%299
7
Drug Ineffective2.9%291
8
Hypersensitivity2.7%278
9
Haematotoxicity2.5%251
10
Pneumonia2.3%237
11
Secondary Immunodeficiency2.3%236
12
Viral Infection2.3%235
13
Drug Interaction2.3%230
14
Clostridium Difficile Colitis2.2%228
15
Posterior Reversible Encephalopathy Syndrome2.2%227

These are voluntary reports and do not establish that asparaginase caused these reactions.

Report severity

93.8%Serious9,542 reports
35.2%Hospitalizations3,576 reports
21.7%Fatal2,209 reports

Seriousness is determined by the reporter, not by OpenClaim.

Asparaginase drug interactions

Other drugs that appear in adverse event reports alongside asparaginase. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Vincristine-sulfate60.5%6,149
2
Methotrexate55.9%5,680
3
Cytarabine41.0%4,167
4
Dexamethasone36.4%3,704
5
Daunorubicin31.8%3,235
6
Cyclophosphamide29.4%2,994
7
Prednisone24.4%2,484
8
Mercaptopurine23.1%2,349
9
Doxorubicin-hydrochloride19.7%2,004
10
Etoposide16.2%1,650
11
Prednisolone11.7%1,193
12
Hydrocortisone10.3%1,051
13
Thioguanine7.1%719
14
Methylprednisolone6.6%667
15
Pegaspargase6.3%643

Taken alongside

1
Vincristine-sulfate11.6%1,182
2
Methotrexate8.7%889
3
Cytarabine7.1%717
4
Dexamethasone7.1%717
5
Daunorubicin6.4%651
6
Cyclophosphamide5.4%550
7
Mercaptopurine5.3%537
8
Prednisone5.0%504
9
Ondansetron4.3%439
10
Sulfamethoxazole4.2%423
11
Trimethoprim4.1%414
12
Doxorubicin-hydrochloride4.0%404
13
Fluconazole2.7%273
14
Prednisolone2.5%259
15
Hydrocortisone2.5%256

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports asparaginase side effects

32.9% of asparaginase adverse event reports involve female patients and 43.1% involve male patients. The largest age group is child at 39%. These figures reflect who reports side effects, not underlying risk.

Sex

Female32.9%
Male43.1%
Unknown24.1%

Age group

< 26.0%
2–1139.2%
12–1720.6%
18–6429.8%
65+4.5%

What is asparaginase used for

Conditions and purposes for which patients were taking asparaginase when the adverse event was reported.

Acute Lymphoblastic LeukemiaAcute Biphenotypic LeukaemiaAcute LeukaemiaAcute Lymphoblastic LeukaemiaAcute Lymphoblastic LeukemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia (in Remission)Acute Lymphocytic Leukaemia RecurrentAcute Lymphocytic Leukaemia RefractoryAcute Megakaryocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Undifferentiated Leukaemia

Showing 15 of 279 indications

Asparaginase brand names and reporting trend

Asparaginase is sold under brand names including Elspar, Rylaze.

Brand names

Elspar9,947
Rylaze252

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking asparaginase with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.