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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

CALASPARGASE PEGOL-MKNL: 505 Adverse Event Reports & Safety Profile

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505
Total FAERS Reports
30 (5.9%)
Deaths Reported
200
Hospitalizations
505
As Primary/Secondary Suspect
58
Life-Threatening
4
Disabilities
Prescription
Status

FDA Application: 761102 ·

First Report: 20220110 · Latest Report: 20250918

What Are the Most Common CALASPARGASE PEGOL-MKNL Side Effects?

#1 Most Reported
Hypersensitivity
155 reports (30.7%)
#2 Most Reported
Anaphylactic reaction
76 reports (15.0%)
#3 Most Reported
Pancreatitis
56 reports (11.1%)

All CALASPARGASE PEGOL-MKNL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hypersensitivity 155 30.7% 0 28
Anaphylactic reaction 76 15.1% 0 40
Pancreatitis 56 11.1% 3 26
Infusion related reaction 51 10.1% 0 24
Vomiting 37 7.3% 2 21
Tachycardia 20 4.0% 2 13
Nausea 19 3.8% 0 9
Cough 18 3.6% 0 13
Hypertriglyceridaemia 18 3.6% 1 10
Neutropenia 15 3.0% 2 5
Venoocclusive liver disease 15 3.0% 5 13
Septic shock 14 2.8% 6 11
Pancreatitis acute 13 2.6% 0 9
Abdominal pain 12 2.4% 0 9
Hyperglycaemia 12 2.4% 1 5
Hypotension 12 2.4% 6 11
Drug specific antibody present 11 2.2% 0 0
Thrombocytopenia 11 2.2% 3 8
Urticaria 11 2.2% 0 5
Cardiac arrest 10 2.0% 9 8

Who Reports CALASPARGASE PEGOL-MKNL Side Effects? Age & Gender Data

Gender: 45.5% female, 54.5% male. Average age: 13.2 years. Most reports from: US. View detailed demographics →

Is CALASPARGASE PEGOL-MKNL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2022 19 1 10
2023 213 8 87
2024 121 10 49
2025 63 7 32

View full timeline →

What Is CALASPARGASE PEGOL-MKNL Used For?

IndicationReports
Acute lymphocytic leukaemia 156
Product used for unknown indication 122
B-cell type acute leukaemia 84
T-cell type acute leukaemia 29
B precursor type acute leukaemia 12
Leukaemia 11
T-cell lymphoma 7
Precursor t-lymphoblastic lymphoma/leukaemia 6
Ductal adenocarcinoma of pancreas 5
Non-hodgkin's lymphoma 5

CALASPARGASE PEGOL-MKNL vs Alternatives: Which Is Safer?

CALASPARGASE PEGOL-MKNL vs CALCIFEDIOL CALASPARGASE PEGOL-MKNL vs CALCIPOTRIENE CALASPARGASE PEGOL-MKNL vs CALCITONIN CALASPARGASE PEGOL-MKNL vs CALCITONIN SALMON CALASPARGASE PEGOL-MKNL vs CALCITRIOL CALASPARGASE PEGOL-MKNL vs CALCITRIOL\CALCIUM\ZINC CALASPARGASE PEGOL-MKNL vs CALCIUM CALASPARGASE PEGOL-MKNL vs CALCIUM ASCORBATE CALASPARGASE PEGOL-MKNL vs CALCIUM, DIBASIC, ANHYDROUS\MAGNESIUM GLYCEROPHOSPHATE\PHOSPHORIC ACID\SODIUM, DIBASIC CALASPARGASE PEGOL-MKNL vs CALCIUM GLUBIONATE

Official FDA Label for CALASPARGASE PEGOL-MKNL

Official prescribing information from the FDA-approved drug label.