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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.

CEDAZURIDINE\DECITABINE: 1,287 Adverse Event Reports & Safety Profile

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1,287
Total FAERS Reports
286 (22.2%)
Deaths Reported
607
Hospitalizations
1,287
As Primary/Secondary Suspect
16
Life-Threatening
3
Disabilities

First Report: 20190122 · Latest Report: 20250919

What Are the Most Common CEDAZURIDINE\DECITABINE Side Effects?

#1 Most Reported
Transfusion
229 reports (17.8%)
#2 Most Reported
Fatigue
228 reports (17.7%)
#3 Most Reported
Platelet count decreased
212 reports (16.5%)

All CEDAZURIDINE\DECITABINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Transfusion 229 17.8% 52 105
Fatigue 228 17.7% 43 98
Platelet count decreased 212 16.5% 41 104
Death 205 15.9% 205 87
Full blood count abnormal 188 14.6% 30 97
White blood cell count decreased 175 13.6% 28 92
Inappropriate schedule of product administration 174 13.5% 17 87
Product use issue 150 11.7% 33 69
Therapy interrupted 150 11.7% 24 62
Haemoglobin decreased 132 10.3% 26 74
Product use in unapproved indication 114 8.9% 18 57
Asthenia 105 8.2% 22 63
Nausea 105 8.2% 20 48
Pneumonia 90 7.0% 23 74
General physical health deterioration 87 6.8% 20 35
Pyrexia 84 6.5% 24 64
Constipation 82 6.4% 10 38
Drug ineffective 74 5.8% 7 36
Neutrophil count decreased 74 5.8% 10 26
Diarrhoea 71 5.5% 11 35

Who Reports CEDAZURIDINE\DECITABINE Side Effects? Age & Gender Data

Gender: 41.6% female, 58.4% male. Average age: 75.3 years. Most reports from: US. View detailed demographics →

Is CEDAZURIDINE\DECITABINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2019 2 0 2
2020 54 15 26
2021 172 50 87
2022 162 58 91
2023 112 33 69
2024 108 28 66
2025 54 13 27

View full timeline →

What Is CEDAZURIDINE\DECITABINE Used For?

IndicationReports
Myelodysplastic syndrome 770
Product used for unknown indication 162
Chronic myelomonocytic leukaemia 135
Acute myeloid leukaemia 103
Refractory anaemia with an excess of blasts 11
Myelodysplastic syndrome with excess blasts 10
Thrombocytopenia 8
Chronic myeloid leukaemia 7
Illness 7
Myelodysplastic syndrome with multilineage dysplasia 7

CEDAZURIDINE\DECITABINE vs Alternatives: Which Is Safer?

CEDAZURIDINE\DECITABINE vs CEDIRANIB CEDAZURIDINE\DECITABINE vs CEFACLOR CEDAZURIDINE\DECITABINE vs CEFADROXIL CEDAZURIDINE\DECITABINE vs CEFAZOLIN CEDAZURIDINE\DECITABINE vs CEFDINIR CEDAZURIDINE\DECITABINE vs CEFEPIME CEDAZURIDINE\DECITABINE vs CEFEPIME\CEFEPIME CEDAZURIDINE\DECITABINE vs CEFIDEROCOL CEDAZURIDINE\DECITABINE vs CEFIXIME CEDAZURIDINE\DECITABINE vs CEFMETAZOLE

Official FDA Label for CEDAZURIDINE\DECITABINE

Official prescribing information from the FDA-approved drug label.