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)
Tachycardia02.03.02.0070.000280%Not Available
Therapeutic response decreased08.06.01.0160.000112%Not Available
Thrombocytopenia01.08.01.0020.000694%Not Available
Thrombocytopenic purpura23.06.01.007; 01.08.01.003--Not Available
Thrombotic microangiopathy24.01.01.013; 20.01.07.004; 01.01.02.0060.000168%Not Available
Toxic encephalopathy17.13.01.004; 12.03.01.0270.000168%Not Available
Toxic epidermal necrolysis10.01.01.006; 23.03.01.008; 12.03.01.015; 11.07.01.006--
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tumour lysis syndrome14.05.01.004; 16.32.03.0020.000168%
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary hesitation20.02.02.009--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Venoocclusive liver disease09.01.06.002; 12.02.09.039; 24.04.07.0020.000336%
Viral infection11.05.04.001--Not Available
Vision blurred17.17.01.010; 06.02.06.0070.000224%
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Mental status changes19.07.01.0010.000224%Not Available
Hypoacusis04.02.01.006--
Brain oedema12.01.10.010; 17.07.02.0030.000392%
Deep vein thrombosis24.01.02.003--Not Available
Post transplant lymphoproliferative disorder16.21.02.004; 11.05.10.006; 01.13.02.0040.000168%Not Available
Malignant neoplasm progression16.16.01.0050.000280%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Cytokine release syndrome10.02.01.0100.002630%
Protein urine present13.13.02.006--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Acquired haemophilia01.01.01.002--Not Available
Evans syndrome10.04.01.003; 01.06.01.002--Not Available
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