Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Clofarabine
Drug ID BADD_D00495
Description Clofarabine is a purine nucleoside antimetabolite that is being studied in the treatment of cancer. It is marketed as Clolar in the U.S. and Canada, or Evoltra in Europe, Australia, and New Zealand. Clofarabine is used in paediatrics to treat a type of leukaemia called relapsed or refractory acute lymphoblastic leukaemia (ALL), only after at least two other types of treatment have failed. It is not known if the drug extends life expectancy. Its potential use in acute myeloid leukaemia (AML) and juvenile myelomonocytic leukaemia (JMML) has been investigated.
Indications and Usage For the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphocytic (lymphoblastic) leukemia after at least two prior regimens. It is designated as an orphan drug by the FDA for this use.
Marketing Status approved; investigational
ATC Code L01BB06
DrugBank ID DB00631
KEGG ID D03546
MeSH ID D000077866
PubChem ID 119182
TTD Drug ID D0R5RR
NDC Product Code 67430-250; 49315-003; 60505-6166; 72266-108; 0024-5860; 68083-386; 54893-0028; 70121-1236; 67457-546; 71288-128; 0955-1746; 42973-173; 76055-0016; 63323-572; 65129-1278; 82920-024; 43598-309; 17337-0310; 55150-326
UNII 762RDY0Y2H
Synonyms Clofarabine | 2-Chloro-9-(2-deoxy-2-fluoroarabinofuranosyl)adenine | Cl-F-ara-A | 2-Chloro-9-(2-deoxy-2-fluoro-beta-D-arbinofuranosyl)adenine | 2-Chloro-2'-arabino-fluoro-2'-deoxyadenosine | 2 Chloro 2' arabino fluoro 2' deoxyadenosine | 2-Chloro-2'-fluoroarabino-2'-deoxyadenosine | 2 Chloro 2' fluoroarabino 2' deoxyadenosine | 9H-Purin-6-amine, 2-chloro-9-(2-deoxy-2-fluoro-beta-D-arabinofuranosyl)- | Clolar | Evoltra | Clofarex
Chemical Information
Molecular Formula C10H11ClFN5O3
CAS Registry Number 123318-82-1
SMILES C1=NC2=C(N=C(N=C2N1C3C(C(C(O3)CO)O)F)Cl)N
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)
Rash maculo-papular23.03.13.004--
Rash pruritic23.03.13.0300.000112%Not Available
Renal failure20.01.03.0050.000168%Not Available
Respiratory distress22.02.01.012--Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000504%
Sepsis11.01.11.003--
Septic shock24.06.02.011; 11.01.11.004--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.003--Not Available
Skin hyperpigmentation23.05.01.003--
Skin reaction23.03.03.013; 10.01.03.019--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Stomatitis07.05.06.005--
Tachycardia02.03.02.0070.000246%Not Available
Tachypnoea22.02.01.014--Not Available
Thrombocytopenia01.08.01.0020.000280%Not Available
Thrombosis24.01.01.0060.000112%Not Available
Toxic epidermal necrolysis12.03.01.015; 11.07.01.006; 10.01.01.006; 23.03.01.0080.000224%
Tremor17.01.06.002--
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000112%
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Viral infection11.05.04.001--Not Available
Vomiting07.01.07.0030.000112%
Weight decreased13.15.01.005--
Mental status changes19.07.01.001--Not Available
Hypoacusis04.02.01.006--
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ADReCS-Target
Drug Name ADR Term Target
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