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%-
Renal failure20.01.03.0050.000168%-
Respiratory distress22.02.01.012---
Respiratory failure14.01.04.003; 22.02.06.0020.000504%
Sepsis11.01.11.003--
Septic shock11.01.11.004; 24.06.02.011---
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007---
Skin exfoliation23.03.07.003---
Skin hyperpigmentation23.05.01.003--
Skin reaction10.01.03.019; 23.03.03.013---
Somnolence17.02.04.006; 19.02.05.003--
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.007--
Stomatitis07.05.06.005--
Tachycardia02.03.02.0070.000246%-
Tachypnoea22.02.01.014---
Thrombocytopenia01.08.01.0020.000280%-
Thrombosis24.01.01.0060.000112%-
Toxic epidermal necrolysis10.01.01.006; 11.07.01.006; 12.03.01.015; 23.03.01.0080.000224%
Tremor17.01.06.002--
Tumour lysis syndrome14.05.01.004; 16.32.03.0020.000112%
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urethral disorder20.07.01.002---
Urinary tract disorder20.08.01.001---
Viral infection11.05.04.001---
Vomiting07.01.07.0030.000112%
Weight decreased13.15.01.005--
Mental status changes19.07.01.001---
Hypoacusis04.02.01.006--
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ADReCS-Target
Drug Name ADR Term Target
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