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)
Gastrointestinal necrosis07.15.01.003; 24.04.08.0060.000280%
Generalised oedema08.01.07.004; 14.05.06.0070.000224%
Generalised tonic-clonic seizure17.12.01.0020.000302%-
Gingival bleeding07.09.07.001; 24.07.02.0100.000280%-
Graft versus host disease10.02.01.027; 12.02.09.0010.000224%-
Granulocytopenia01.02.03.0030.000112%-
Guillain-Barre syndrome10.04.10.005; 11.07.01.001; 17.09.01.0010.000168%
Haematemesis07.12.02.002; 24.07.02.0110.000168%-
Haematoma24.07.01.0010.000168%
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.0470.000224%
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.0060.000504%-
Haemorrhage intracranial17.08.01.008; 24.07.04.0030.000728%
Haemorrhoids07.15.03.001; 24.10.02.0020.000168%
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.000224%-
Hepatic failure09.01.03.0020.000392%
Hepatic function abnormal09.01.02.0010.000526%-
Hepatitis09.01.07.0040.000392%-
Hepatocellular injury09.01.07.0080.000168%-
Hepatosplenomegaly01.09.03.001; 09.01.05.0020.000112%-
Hepatotoxicity09.01.07.009; 12.03.01.0080.000638%-
Hiccups07.01.06.009; 22.12.01.0010.000224%
Hidradenitis23.02.03.0130.001063%-
Hyperaemia24.03.02.0020.000112%-
Hyperammonaemia09.01.02.002; 14.10.01.0010.000112%-
Hyperbilirubinaemia01.06.04.003; 09.01.01.003; 14.11.01.0100.001343%-
Hyperkalaemia14.05.03.0010.000224%
Hypernatraemia14.05.04.0010.000112%
Hyperpyrexia08.05.02.0020.000112%-
Hypertension24.08.02.0010.001220%
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ADReCS-Target
Drug Name ADR Term Target
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