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)
Retching07.01.07.0020.000358%Not Available
Reticulocytosis01.07.02.0020.000168%Not Available
Retinopathy24.03.07.003; 06.10.02.0010.000112%
Skin cancer23.08.02.002; 16.03.02.0020.000168%Not Available
Skin hyperpigmentation23.05.01.0030.000112%
Skin lesion23.03.03.0100.000795%Not Available
Spinal osteoarthritis15.01.04.0030.000112%Not Available
Splenic infarction24.04.08.024; 01.09.02.0040.000112%Not Available
Splenomegaly01.09.02.0010.001388%Not Available
Squamous cell carcinoma16.16.01.0020.000168%Not Available
Swelling08.01.03.015--Not Available
Tachypnoea22.02.01.0140.000168%Not Available
Thrombocytopenia01.08.01.0020.006570%Not Available
Thrombocytosis01.08.02.0010.000302%Not Available
Toothache07.09.06.0010.000112%
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.006100%
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract disorder20.08.01.0010.000112%Not Available
Vomiting07.01.07.003--
Waldenstrom's macroglobulinaemia16.28.03.001; 01.15.03.0010.000168%Not Available
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.000884%Not Available
Musculoskeletal disorder15.03.05.0250.000246%Not Available
Hypoacusis04.02.01.0060.000660%
Peripheral swelling08.01.03.053; 02.05.04.015--Not Available
General physical health deterioration08.01.03.0180.002227%Not Available
Cytokine storm10.02.01.0400.000112%Not Available
Cardiopulmonary failure22.02.06.004; 02.05.01.0040.000224%Not Available
Drug tolerance08.06.01.0030.000381%Not Available
Organ failure08.01.03.0410.000112%Not Available
Blast cell crisis16.01.02.002; 01.10.02.0020.000112%Not Available
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