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)
Abdominal pain07.01.05.002--
Acute leukaemia16.01.02.001; 01.10.02.001--Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.001343%Not Available
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.0340.000168%
Adrenal insufficiency14.11.01.004; 05.01.02.0010.000112%
Agitation19.06.02.001; 17.02.05.0120.000280%
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Aneurysm24.02.01.001--Not Available
Angina pectoris24.04.04.002; 02.02.02.0020.000112%
Angioimmunoblastic T-cell lymphoma16.17.05.001; 01.11.05.0010.000112%Not Available
Aphasia19.21.01.001; 17.02.03.0010.000168%
Aplasia08.03.04.003; 03.02.01.002--Not Available
Aplasia pure red cell10.02.01.003; 01.03.03.0010.000112%Not Available
Apnoea22.02.01.0010.000112%
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Basal cell carcinoma23.08.02.001; 16.03.02.0010.000246%Not Available
Blindness06.02.10.003; 17.17.01.0030.000224%Not Available
Blood lactate dehydrogenase increased13.04.02.002--
Blood uric acid increased13.02.04.001--Not Available
Body temperature increased13.15.01.001--Not Available
Bone pain15.02.01.0010.000168%
Bronchitis22.07.01.001; 11.01.09.001--
Cardiac failure02.05.01.0010.000224%
Cardiac failure congestive02.05.01.002--Not Available
Cardiomyopathy02.04.01.0010.000168%Not Available
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