Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cytarabine
Drug ID BADD_D00560
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 D00168
MeSH ID D003561
PubChem ID 6253
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 04079A1RDZ
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
CAS Registry Number 147-94-4
SMILES C1=CN(C(=O)N=C1N)C2C(C(C(O2)CO)O)O
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)
Intra-abdominal haemorrhage24.07.02.035; 12.01.17.011; 07.12.02.0080.000112%
Ischaemia24.04.02.0040.000168%Not Available
Neoplasm progression16.16.02.0050.001455%Not Available
Spinal cord disorder17.10.01.0100.000112%Not Available
Decreased appetite08.01.09.028; 14.03.01.005--
Renal injury20.01.03.015; 12.01.05.0010.000224%Not Available
Ill-defined disorder08.01.03.0490.000224%Not Available
Blood disorder01.05.01.0040.000112%Not Available
Immunodeficiency10.03.02.0020.000112%Not Available
Autoimmune disorder10.04.04.0030.000246%
Bone marrow disorder01.05.01.0060.000168%Not Available
Disease recurrence08.01.03.0500.000783%Not Available
Fat necrosis08.03.03.0040.000112%Not Available
Neoplasm recurrence16.16.02.0040.000224%Not Available
Pulmonary toxicity22.01.02.007; 12.03.01.0130.000448%Not Available
Hepatic lesion09.01.08.0050.000168%Not Available
Immunosuppressant drug level13.17.01.012--Not Available
Immunosuppression10.03.02.0010.000112%Not Available
Large intestinal obstruction07.13.03.0030.000168%
Renal impairment20.01.03.010--Not Available
Neutropenic colitis07.08.01.014; 01.02.03.0100.002183%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.000526%Not Available
Gastrointestinal inflammation07.08.03.0070.000224%Not Available
Infusion site extravasation12.07.05.008; 08.02.05.0070.000112%
Immune reconstitution inflammatory syndrome10.02.01.043; 08.06.02.0140.000224%Not Available
Bone marrow failure01.03.03.0050.002686%
Iron overload14.13.03.002; 12.02.08.0050.000224%
Acute graft versus host disease12.02.09.002; 10.02.01.0280.000280%Not Available
Chronic graft versus host disease12.02.09.003; 10.02.01.0290.000112%Not Available
Cytopenia01.03.03.0120.000694%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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