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 leukaemia01.10.02.001; 16.01.02.001---
Acute myeloid leukaemia01.10.05.001; 16.01.05.0010.001343%-
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.0340.000168%
Adrenal insufficiency05.01.02.001; 14.11.01.0040.000112%
Agitation17.02.05.012; 19.06.02.0010.000280%
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Anaphylactic shock10.01.07.002; 24.06.02.004---
Aneurysm24.02.01.001---
Angina pectoris02.02.02.002; 24.04.04.0020.000112%
Angioimmunoblastic T-cell lymphoma01.11.05.001; 16.17.05.0010.000112%-
Aphasia17.02.03.001; 19.21.01.0010.000168%
Aplasia03.02.01.002; 08.03.04.003---
Aplasia pure red cell01.03.03.001; 10.02.01.0030.000112%-
Apnoea22.02.01.0010.000112%
Arrhythmia02.03.02.001---
Arthralgia15.01.02.001--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Basal cell carcinoma16.03.02.001; 23.08.02.0010.000246%-
Blindness06.02.10.003; 17.17.01.0030.000224%-
Blood lactate dehydrogenase increased13.04.02.002--
Blood uric acid increased13.02.04.001---
Body temperature increased13.15.01.001---
Bone pain15.02.01.0010.000168%
Bronchitis11.01.09.001; 22.07.01.001--
Cardiac failure02.05.01.0010.000224%
Cardiac failure congestive02.05.01.002---
Cardiomyopathy02.04.01.0010.000168%-
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