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)
Bronchial secretion retention22.03.02.0080.000168%Not Available
Liver injury09.01.07.022; 12.01.17.0120.000392%Not Available
Hyperammonaemic encephalopathy17.13.01.005; 14.10.01.0060.000112%Not Available
Organising pneumonia22.01.02.0080.000168%Not Available
Low birth weight baby18.04.02.0030.000112%Not Available
Cytarabine syndrome15.03.04.016; 08.05.02.010--Not Available
Gastrointestinal sounds abnormal07.01.01.0020.000112%Not Available
Acute haemorrhagic conjunctivitis24.07.05.006; 11.05.14.001; 06.04.01.009--Not Available
Brain injury19.07.03.007; 17.11.01.0030.000112%Not Available
Oropharyngeal pain07.05.05.004; 22.12.03.0160.000470%
Acute kidney injury20.01.03.0160.003425%
Use of accessory respiratory muscles22.12.02.0150.000246%Not Available
Foetal growth restriction18.03.01.0020.000392%
Posterior reversible encephalopathy syndrome17.13.02.0070.001052%
Central nervous system haemorrhage24.07.04.016; 17.08.01.0350.001343%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000504%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.002071%
Jugular vein thrombosis24.01.02.0070.000168%Not Available
Obstruction gastric07.13.04.0020.000168%
Systemic mastocytosis16.21.01.008; 01.13.01.008; 10.02.01.0140.000112%Not Available
Intracranial hypotension17.02.05.036; 12.01.10.0080.000112%Not Available
Transient acantholytic dermatosis23.03.03.0690.000246%Not Available
Multi-organ disorder08.01.03.0740.000168%Not Available
Bone marrow necrosis24.04.09.002; 01.05.01.0120.000168%Not Available
Acute myeloid leukaemia recurrent16.01.05.004; 01.10.05.0040.000392%Not Available
Leukaemia recurrent01.10.03.005; 16.01.03.0050.000112%Not Available
Acute lymphocytic leukaemia recurrent16.01.01.003; 01.10.01.0030.000246%Not Available
Renal ischaemia24.04.11.005; 20.01.07.0150.000112%Not Available
Oncologic complication16.32.03.0250.000112%Not Available
Seizure like phenomena17.12.03.0300.000112%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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