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)
Pleural effusion22.05.02.0020.000224%
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pneumonitis22.01.01.0060.000224%
Progressive multifocal leukoencephalopathy17.16.02.002; 11.05.05.001--Not Available
Proteinuria20.02.01.011--
Pruritus23.03.12.001--
Pulmonary fibrosis22.01.02.006--
Pulmonary haemorrhage22.12.01.009; 24.07.01.016--
Pyrexia08.05.02.0030.002597%
Radial nerve palsy17.09.02.004--Not Available
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.0040.000168%
Renal failure20.01.03.0050.000224%Not Available
Respiratory distress22.02.01.012--Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000672%
Rhinitis22.07.03.006; 11.01.13.004--
Seborrhoeic dermatitis23.03.04.018--Not Available
Second primary malignancy16.16.01.0140.000672%
Seizure17.12.03.001--
Sinusitis22.07.03.007; 11.01.13.005--
Skin cancer16.03.02.002; 23.08.02.002--Not Available
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.0030.000112%Not Available
Sleep disorder19.02.04.001--Not Available
Speech disorder19.19.02.002; 17.02.08.003; 22.12.03.0270.000112%Not Available
Splenomegaly01.09.02.0010.000336%Not Available
Squamous cell carcinoma16.16.01.0020.000414%Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.0050.000112%
Stomatitis07.05.06.0050.000336%
Supraventricular tachycardia02.03.03.012--
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