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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.

CYTARABINE\DAUNORUBICIN: 2,025 Adverse Event Reports & Safety Profile

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2,025
Total FAERS Reports
537 (26.5%)
Deaths Reported
536
Hospitalizations
2,025
As Primary/Secondary Suspect
164
Life-Threatening
7
Disabilities

First Report: 20090523 · Latest Report: 20250913

What Are the Most Common CYTARABINE\DAUNORUBICIN Side Effects?

#1 Most Reported
Febrile neutropenia
394 reports (19.5%)
#2 Most Reported
Acute myeloid leukaemia
175 reports (8.6%)
#3 Most Reported
Pyrexia
157 reports (7.8%)

All CYTARABINE\DAUNORUBICIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Febrile neutropenia 394 19.5% 85 136
Acute myeloid leukaemia 175 8.6% 121 39
Pyrexia 157 7.8% 26 62
Death 147 7.3% 147 20
Sepsis 126 6.2% 67 52
Off label use 119 5.9% 24 17
Pneumonia 118 5.8% 50 52
Rash 109 5.4% 6 38
Acute myeloid leukaemia recurrent 83 4.1% 17 18
Disease progression 79 3.9% 30 9
Therapeutic product effect incomplete 77 3.8% 24 18
Septic shock 71 3.5% 30 26
Drug ineffective 67 3.3% 9 11
Neutropenia 65 3.2% 7 25
Cytopenia 55 2.7% 18 12
Thrombocytopenia 52 2.6% 6 25
Bacteraemia 49 2.4% 10 18
Infection 45 2.2% 23 14
Mucosal inflammation 45 2.2% 4 5
Bone marrow failure 43 2.1% 10 16

Who Reports CYTARABINE\DAUNORUBICIN Side Effects? Age & Gender Data

Gender: 41.5% female, 58.5% male. Average age: 60.1 years. Most reports from: JP. View detailed demographics →

Is CYTARABINE\DAUNORUBICIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 4 0 4
2017 15 2 7
2018 105 41 41
2019 198 40 84
2020 185 51 50
2021 140 32 56
2022 65 20 32
2023 93 16 34
2024 254 73 87
2025 122 50 44

View full timeline →

What Is CYTARABINE\DAUNORUBICIN Used For?

IndicationReports
Acute myeloid leukaemia 1,272
Product used for unknown indication 554
Myelodysplastic syndrome 88
Bone marrow conditioning regimen 15
Chronic myelomonocytic leukaemia 15
Acute myeloid leukaemia refractory 13
Acute myeloid leukaemia recurrent 10
Leukaemia 8
Acute leukaemia 6
Myelofibrosis 6

CYTARABINE\DAUNORUBICIN vs Alternatives: Which Is Safer?

CYTARABINE\DAUNORUBICIN vs DABIGATRAN CYTARABINE\DAUNORUBICIN vs DABIGATRAN ETEXILATE CYTARABINE\DAUNORUBICIN vs DABRAFENIB CYTARABINE\DAUNORUBICIN vs DABRAFENIB\TRAMETINIB CYTARABINE\DAUNORUBICIN vs DACARBAZINE CYTARABINE\DAUNORUBICIN vs DACLATASVIR CYTARABINE\DAUNORUBICIN vs DACLIZUMAB CYTARABINE\DAUNORUBICIN vs DACOMITINIB CYTARABINE\DAUNORUBICIN vs DACTINOMYCIN CYTARABINE\DAUNORUBICIN vs DALBAVANCIN

Official FDA Label for CYTARABINE\DAUNORUBICIN

Official prescribing information from the FDA-approved drug label.