Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Venetoclax
Drug ID BADD_D02345
Description Venetoclax is a BCL-2 inhibitor that was initially approved by the FDA in April 2016 [FDA label]. Proteins in the B cell CLL/lymphoma 2 (BCL-2) family are important regulators of the apoptotic (programmed cell death) process [A18565], [A18566]. Venetoclax is used to treat chronic lymphocytic leukemia (CLL) and certain types of small lymphocytic lymphoma [FDA label]. CLL is the most prevalent leukemia diagnosed in Western countries [A40022]. Venetoclax was developed through reverse engineering of the BCL-2 protein family inhibitor, navitoclax [A40022]. Venetoclax is approximately 10 times more potent than navitoclax with regard to induction of apoptosis in CLL cells [A40022]. A new indication was approved in 2018 for the treatment patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy [FDA label]. Previously, this drug was indicated only for patients with 17p gene deletion [F2130].
Indications and Usage A BCL-2 inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy [FDA label].
Marketing Status approved; investigational
ATC Code L01XX52
DrugBank ID DB11581
KEGG ID D10679
MeSH ID C579720
PubChem ID 49846579
TTD Drug ID Not Available
NDC Product Code 76462-0576; 0074-0576; 0074-0579; 71796-008; 0074-0566; 68543-0576; 54893-0090; 68513-0566; 0074-0561; 68513-0576; 68513-0561
UNII N54AIC43PW
Synonyms venetoclax | 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide | benzamide, 4-(4-((2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl)methyl)-1-piperazinyl)-n-((3-nitro-4-(((tetrahydro-2h-pyran-4-yl)methyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)- | GDC-0199 | RG-7601 | RG7601 | ABT-199 | Venclexta
Chemical Information
Molecular Formula C45H50ClN7O7S
CAS Registry Number 1257044-40-8
SMILES CC1(CCC(=C(C1)C2=CC=C(C=C2)Cl)CN3CCN(CC3)C4=CC(=C(C=C4)C(=O)NS(=O)(=O)C5=CC(=C(C =C5)NCC6CCOCC6)[N+](=O)[O-])OC7=CN=C8C(=C7)C=CN8)C
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)
Fluid intake reduced14.05.10.0010.000112%Not Available
Pulmonary mass22.02.07.0040.000448%Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.0060.000168%Not Available
Neurological symptom17.02.05.0100.000358%Not Available
General symptom08.01.03.0210.000358%Not Available
Bladder disorder20.03.01.0020.000112%Not Available
Haematotoxicity12.03.01.025; 01.05.01.0070.000783%Not Available
Infarction24.04.02.0170.000112%Not Available
Inflammation10.02.01.089; 08.01.05.0070.000336%Not Available
Intervertebral disc degeneration15.10.01.0020.000168%Not Available
Intra-abdominal haemorrhage12.01.17.011; 24.07.02.035; 07.12.02.0080.000112%
Ischaemia24.04.02.0040.000112%Not Available
Malnutrition14.03.02.0040.000112%Not Available
Mantle cell lymphoma16.28.05.001; 01.15.05.0010.001287%Not Available
White blood cell disorder01.02.05.0020.000246%Not Available
Renal injury20.01.03.015; 12.01.05.0010.000224%Not Available
Blood disorder01.05.01.0040.000336%Not Available
Immunodeficiency10.03.02.0020.000526%Not Available
Autoimmune disorder10.04.04.0030.000112%
Disease progression08.01.03.0380.009906%
Hepatic lesion09.01.08.0050.000224%Not Available
Immunosuppression10.03.02.0010.000168%Not Available
Metastasis16.22.01.0010.000112%Not Available
Unevaluable event08.01.03.0510.001399%Not Available
Neutropenic colitis07.08.01.014; 01.02.03.0100.000112%Not Available
Hypophagia07.01.06.010; 19.09.01.004; 14.03.01.0060.000448%Not Available
Gastrointestinal inflammation07.08.03.0070.000112%Not Available
Bone marrow failure01.03.03.0050.001175%
Cytopenia01.03.03.0120.006458%Not Available
Adverse reaction08.06.01.0180.000168%Not Available
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