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What the label lists and what reports show

Asparaginase side effects

Asparaginase's FDA label: “Most common adverse reactions (incidence > 20%) are abnormal liver test, nausea, musculoskeletal pain, infection, fatigue, headache, febrile neutropenia, pyrexia, hemorrhage, stomatitis, abdominal pain, decreased appetite, drug hypersensitivity …” FAERS holds 309 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 hyperammonaemia (31 reports).

  • No generic listed

Check it at the source: the asparaginase FDA label on DailyMed (effective July 1, 2025); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence > 20%) are abnormal liver test, nausea, musculoskeletal pain, infection, fatigue, headache, febrile neutropenia, pyrexia, hemorrhage, stomatitis, abdominal pain, decreased appetite, drug hypersensitivity, hyperglycemia, diarrhea, pancreatitis, and hypokalemia.

Table 3: Adverse Reactions (≥ 15% Incidence) in Patients Receiving RYLAZE as a Component of Multi-Agent Chemotherapy in Study JZP458-201

ReactionAll Grades (%)Grades 3-4 (%)All Grades (%)Grades 3-4 (%)
Abnormal liver test70187527
Musculoskeletal pain456354
Nausea459478
Fatigue36182218
Headache360220
Infection* b36152717
Febrile neutropenia30302727
Pyrexia306200
Hemorrhage240276
Stomatitis2412274
Abdominal pain210252
Decreased appetite216276
Drug hypersensitivity216242
Hyperglycemia213124
Diarrhea186254
Tachycardia180162
Cough150140
Dehydration159126
Insomnia15040
Peripheral neuropathy15060
Pancreatitis1202210
Hypokalemia93228

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, continued

The following clinically significant adverse reactions are described in greater detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Pancreatic Toxicity [see Warnings and Precautions ( 5.2 )] • Thrombosis [see Warnings and Precautions ( 5.3 )] • Hemorrhage [see Warnings and Precautions ( 5.4 )] • Hepatotoxicity, including VOD [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence > 20%) are abnormal liver test, nausea, musculoskeletal pain, infection, fatigue, headache, febrile neutropenia, pyrexia, hemorrhage, stomatitis, abdominal pain, decreased appetite, drug hypersensitivity, hyperglycemia, diarrhea, pancreatitis, and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals Ireland Limited at 1-800-520-5568 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, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

Source: FDA drug label, Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 857e53aa-1098-4dad-b654-0276cdd43e03), via openFDA; the full label on DailyMed

What do FAERS reports show?

309 reports list asparaginase among the medicines taken, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 98 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. Of the 22 reactions below, 13 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.

The 25 most reported reactions

  • Hyperammonaemia (named in the label)31
  • Febrile Neutropenia (named in the label)25
  • Off Label Use (a use or a product term, not a reaction)25
  • Nausea (named in the label)24
  • Hypersensitivity (a use or a product term, not a reaction)21
  • Pancreatitis (named in the label)18
  • Urticaria (named in the label)17
  • Vomiting (named in the label)17
  • Rash (named in the label)16
  • Neutropenia (named in the label)15
  • Ammonia Increased12
  • Anaphylactic Reaction12
  • Herpes Simplex11
  • Systemic Candida11
  • Cerebral Candidiasis10
  • Respiratory Moniliasis10
  • Skin Candida10
  • Pyrexia (named in the label)9
  • Stomatococcal Infection9
  • Drug Hypersensitivity (named in the label)7
  • Escherichia Bacteraemia7
  • Death (an outcome recorded in the report)6
  • Haemorrhage (named in the label)6
  • Sepsis (named in the label)6
  • Thrombocytopenia (named in the label)6

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Asparaginase: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions