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 For the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.
Marketing Status Prescription
ATC Code L01XX52
DrugBank ID DB11581
KEGG ID D10679
MeSH ID C579720
PubChem ID 49846579
TTD Drug ID Not Available
NDC Product Code 68513-0566; 0074-0576; 68513-0561; 54893-0090; 68543-0576; 71796-008; 0074-0579; 68513-0576; 0074-0566; 0074-0561; 46708-920
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Respiratory distress22.02.01.0120.001066%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.001112%
Retching07.01.07.0020.000799%Not Available
Retinopathy24.03.07.003; 06.10.02.0010.000533%
Rhinorrhoea22.02.05.010--
Seizure17.12.03.001--
Sepsis11.01.11.0030.004170%
Septic shock24.06.02.011; 11.01.11.0040.001320%Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin discolouration23.03.03.005--Not Available
Skin hyperpigmentation23.05.01.0030.000533%
Skin lesion23.03.03.0100.001332%Not Available
Somnolence17.02.04.006; 19.02.05.003--
Speech disorder22.02.05.034; 19.19.02.002; 17.02.08.003--Not Available
Splenic infarction24.04.07.003; 01.09.02.0040.000533%Not Available
Splenomegaly01.09.02.0010.003730%Not Available
Stomatitis07.05.06.005--
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.011--Not Available
Subdural haematoma24.07.04.005; 17.08.05.002; 12.01.10.0030.000417%Not Available
Swelling08.01.03.015--Not Available
Tachycardia02.03.02.007--Not Available
Tachypnoea22.02.01.0140.000139%Not Available
Thrombocytopenia01.08.01.0020.012255%Not Available
Thrombosis24.01.01.006--Not Available
Transient ischaemic attack17.08.04.001; 24.04.06.005--
Tuberculosis11.04.01.0060.000533%Not Available
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.017317%
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract disorder20.08.01.0010.000533%Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
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