What the label lists and what reports show
Calaspargase side effects
Calaspargase's FDA label: “The most common (incidence ≥10%) grade ≥3 adverse reactions were elevated transaminase, bilirubin increased, pancreatitis, and abnormal clotting studies.” FAERS holds 745 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 hypersensitivity (204 reports).
- No generic listed
Check it at the source: the calaspargase FDA label on DailyMed (effective October 8, 2024); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common (incidence ≥10%) grade ≥3 adverse reactions were elevated transaminase, bilirubin increased, pancreatitis, and abnormal clotting studies.
Table 2: Selected Grades ≥3 Adverse Reactions in Patients Receiving ASPARLAS with Multi-Agent Chemotherapy (Study DFCI 11-001) ASPARLAS or pegaspargase were administered as a component of multi-agent chemotherapy…
| Reaction | ASPARLAS 2,500 U/m 2 N=118 Grades ≥3 n (%) Grading is based on the Common Terminology Criteria for Adverse Events… | Pegaspargase 2,500 U/m 2 N=119 Grades ≥3 n (%) |
|---|---|---|
| Elevated transaminase | 61 (52) | 79 (66) |
| Bilirubin increased | 24 (20) | 30 (25) |
| Pancreatitis | 21 (18) | 29 (24) |
| Abnormal clotting studies | 17 (14) | 25 (21) |
| Diarrhea | 10 (9) | 6 (5) |
| Hypersensitivity | 9 (8) | 8 (7) |
| Embolic and thrombotic events | 9 (8) | 10 (8) |
| Sepsis | 6 (5) | 7 (6) |
| Dyspnea | 5 (4) | 1 (1) |
| Hemorrhages | 5 (4) | 5 (4) |
| Fungal infection | 4 (3) | 3 (3) |
| Pneumonia | 4 (3) | 8 (7) |
| Arrhythmia | 2 (2) | 1 (1) |
| Cardiac failure | 2 (2) | 1 (1) |
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: Hypersensitivity [see Warnings and Precautions (5.1) ] Pancreatitis [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) ] The most common (incidence ≥10%) grade ≥3 adverse reactions were elevated transaminase, bilirubin increased, pancreatitis, and abnormal clotting studies. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Servier Pharmaceuticals LLC 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, 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. Study DFCI 11-001 The safety of ASPARLAS was investigated in Study DFCI 11-001, an open-label, randomized, active-controlled multicenter clinical trial that treated 237 children and adolescents with newly diagnosed ALL or lymphoblastic lymphoma, with ASPARLAS 2,500 U/m 2 (n=118) or pegaspargase 2,500 U/m 2 (n=119) as part of a Dana-Farber Cancer Institute (DFCI) ALL Consortium backbone therapy. …
Source: FDA drug label, Servier Pharmaceuticals LLC, effective October 8, 2024 (SPL set 6585bd0d-bd78-4341-9e87-0f7664821f05), via openFDA; the full label on DailyMed
What do FAERS reports show?
745 reports list calaspargase among the medicines taken, each a report of something that happened, not proof the medicine caused it; 54 are coded as a death and 303 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 25 reactions below, 7 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?
- Calaspargase: 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