Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cytarabine hydrochloride
Drug ID BADD_D00561
Description A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)
Indications and Usage For the treatment of acute non-lymphocytic leukemia, acute lymphocytic leukemia and blast phase of chronic myelocytic leukemia. Cytarabine is indicated in combination with [daunorubicin] for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.[L32843]
Marketing Status approved; investigational
ATC Code L01BC01
DrugBank ID DB00987
KEGG ID D03637
MeSH ID D003561
PubChem ID 6252
TTD Drug ID D07XSN
NDC Product Code 71288-168; 61703-304; 55512-0026; 25021-229; 61703-319; 68083-343; 71288-108; 12848-1003; 71288-109; 71288-169; 58623-0026; 61703-303; 63323-120; 68083-337; 61703-305; 67430-075; 25021-223
UNII 33K3DB6591
Synonyms Cytarabine | Arabinosylcytosine | Cytosine Arabinoside | Arabinoside, Cytosine | Arabinofuranosylcytosine | Aracytidine | beta-Ara C | beta Ara C | Cytarabine Hydrochloride | Cytosar | Cytosar-U | Cytosar U | Ara-C | Ara C | Aracytine | Cytonal
Chemical Information
Molecular Formula C9H13N3O5.ClH
CAS Registry Number 69-74-9
SMILES C1=CN(C(=O)N=C1N)C2C(C(C(O2)CO)O)O.Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.034--
Agitation17.02.05.012; 19.06.02.001--
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.003---
Amnesia17.03.02.001; 19.20.01.001--
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Anaemia megaloblastic01.03.02.003; 14.12.01.003---
Anaphylactic shock10.01.07.002; 24.06.02.004---
Anxiety19.06.02.002--
Arachnoiditis12.02.04.002; 17.06.01.001--
Arthralgia15.01.02.001--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Blindness06.02.10.003; 17.17.01.003---
Blood bilirubin increased13.03.04.018--
Blood uric acid increased13.02.04.001---
Body temperature increased13.15.01.001---
Bone pain15.02.01.001--
Capillary leak syndrome08.01.07.012; 24.06.03.001--
Cardio-respiratory arrest02.03.04.002; 22.02.06.007---
Cardiomegaly02.04.02.001---
Cardiomyopathy02.04.01.001---
Cauda equina syndrome17.10.03.006---
Cellulitis11.02.01.001; 23.11.02.004---
Cerebellar syndrome17.02.02.002---
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Coma17.02.09.001---
Confusional state17.02.03.005; 19.13.01.001--
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