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Cytarabine Side Effects

The most commonly reported side effects of cytarabine include febrile neutropenia, off label use, and pyrexia, based on 63,073 FDA adverse event reports from 2004 to 2025. 4.8% of reports found the drug to be ineffective.

#1 Reported: Febrile NeutropeniaAll side effects ↓Top Co-Medication: MethotrexateDrug interactions ↓54% of Reports Are AdultDemographics ↓

Cytarabine side effects

Percentages show how often each reaction appears relative to total reports for cytarabine.

1
Febrile Neutropenia11.4%7,206
2
Off Label Use8.0%5,061
3
Pyrexia5.7%3,617
4
Neutropenia4.9%3,085
5
Drug Ineffective4.8%3,030
6
Disease Progression4.2%2,662
7
Thrombocytopenia4.0%2,554
8
Sepsis4.0%2,522
9
Myelosuppression3.5%2,195
10
Pneumonia3.3%2,062
11
Death3.1%1,968
12
Pancytopenia2.9%1,809
13
Product Use In Unapproved Indication2.8%1,782
14
Anaemia2.6%1,624
15
Septic Shock2.6%1,614

These are voluntary reports and do not establish that cytarabine caused these reactions.

Report severity

97.1%Serious61,260 reports
40.7%Hospitalizations25,672 reports
22.8%Fatal14,408 reports

Seriousness is determined by the reporter, not by OpenClaim.

Cytarabine drug interactions

Other drugs that appear in adverse event reports alongside cytarabine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Methotrexate35.7%22,541
2
Vincristine-sulfate33.3%21,002
3
Cyclophosphamide31.0%19,583
4
Dexamethasone25.3%15,930
5
Etoposide21.9%13,803
6
Doxorubicin-hydrochloride21.2%13,361
7
Rituximab19.8%12,468
8
Daunorubicin18.2%11,487
9
Prednisone14.0%8,829
10
Pegaspargase9.3%5,869
11
Mercaptopurine9.0%5,683
12
Cisplatin8.9%5,626
13
Fludarabine-phosphate7.6%4,772
14
Idarubicin-hydrochloride7.3%4,576
15
Hydrocortisone6.6%4,154

Taken alongside

1
Dexamethasone7.1%4,488
2
Methotrexate6.1%3,876
3
Cyclophosphamide5.4%3,432
4
Acyclovir5.2%3,306
5
Vincristine-sulfate5.2%3,260
6
Ondansetron5.0%3,161
7
Sulfamethoxazole4.6%2,922
8
Acetaminophen4.5%2,836
9
Trimethoprim4.0%2,545
10
Etoposide3.9%2,455
11
Fluconazole3.3%2,086
12
Doxorubicin-hydrochloride3.3%2,051
13
Allopurinol3.1%1,982
14
Daunorubicin2.9%1,804
15
Prednisone2.8%1,769

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports cytarabine side effects

34.3% of cytarabine adverse event reports involve female patients and 47.2% involve male patients. The largest age group is adult at 54%. These figures reflect who reports side effects, not underlying risk.

Sex

Female34.3%
Male47.2%
Unknown18.4%

Age group

< 22.7%
2–1114.8%
12–179.3%
18–6454.4%
65+18.9%

What is cytarabine used for

Conditions and purposes for which patients were taking cytarabine when the adverse event was reported.

5q Minus SyndromeAbdominal LymphadenopathyAcquired Immunodeficiency SyndromeAcute Lymphoblastic LeukemiaAcute Biphenotypic LeukaemiaAcute Graft Versus Host DiseaseAcute Kidney InjuryAcute LeukaemiaAcute Leukaemia In RemissionAcute LeukemiaAcute Lymphoblastic LeukaemiaAcute Lymphoblastic Leukemia RecurrentAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia (in Remission)Acute Lymphocytic Leukaemia Recurrent

Showing 15 of 1,066 indications

Cytarabine brand names and reporting trend

Cytarabine is sold under the brand name Vyxeos.

Brand names

Vyxeos78,352

Quarterly reports (2004–2025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking cytarabine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.

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