Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fludarabine
Drug ID BADD_D00914
Description Fludarabine is a chemotherapeutic agent used in the treatment of hematological malignancies. It is commonly marketed under the brand name Fludara.
Indications and Usage For the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen
Marketing Status approved
ATC Code L01BB05
DrugBank ID DB01073
KEGG ID D07966
MeSH ID C024352
PubChem ID 657237
TTD Drug ID D0F2XQ
NDC Product Code 16729-131
UNII P2K93U8740
Synonyms fludarabine | 9H-purin-6-amine, 9-beta-D-arabinofuranosyl-2-fluoro- | F-ara-A | 2-fluoroadenine arabinoside | 9-beta-D-arabinofuranosyl-2-fluoroadenine
Chemical Information
Molecular Formula C10H12FN5O4
CAS Registry Number 21679-14-1
SMILES C1=NC2=C(N=C(N=C2N1C3C(C(C(O3)CO)O)O)F)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)
Epilepsy17.12.03.0020.000112%-
Epistaxis22.04.03.001; 24.07.01.005--
Erythema multiforme10.01.03.015; 23.03.01.003--
Fatigue08.01.01.002--
Febrile neutropenia01.02.03.002; 08.05.02.0040.001175%
Feeling abnormal08.01.09.014---
Fibrosis08.03.01.001---
Flank pain08.01.08.007; 15.03.04.003; 20.02.03.006--
Gastrointestinal disorder07.11.01.001---
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Gastrointestinal pain07.01.05.005--
Generalised oedema08.01.07.004; 14.05.06.0070.000112%
Graft versus host disease10.02.01.027; 12.02.09.0010.000672%-
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.0470.000112%
Haemoglobin13.01.05.018---
Haemoglobin decreased13.01.05.003---
Haemolysis01.06.04.0020.000112%
Haemolytic anaemia01.06.03.0020.000280%-
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.006---
Headache17.14.01.001--
Hepatic failure09.01.03.0020.000224%
Hepatic function abnormal09.01.02.0010.000168%-
Hepatitis09.01.07.0040.000280%-
Hepatocellular injury09.01.07.0080.000224%-
Hepatotoxicity09.01.07.009; 12.03.01.0080.000168%-
Herpes simplex11.05.02.001; 23.11.05.004---
Herpes zoster11.05.02.003; 17.09.03.026; 23.11.05.005--
Hodgkin's disease01.16.01.001; 16.31.01.0010.000168%-
Hyperglycaemia05.06.02.002; 14.06.02.0020.000112%
Hyperhidrosis08.01.03.028; 23.02.03.004--
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