Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bedaquiline
Drug ID BADD_D00221
Description Bedaquiline is a bactericidal antimycobacterial drug. Chemically it is a diarylquinoline. FDA approved on December 28, 2012.
Indications and Usage Bedaquiline is indicated as part of combination therapy in adults (≥ 18 years) with pulmonary multi-drug resistant tuberculosis (MDR-TB).
Marketing Status approved
ATC Code J04AK05
DrugBank ID DB08903
KEGG ID D09872
MeSH ID C493870
PubChem ID 5388906
TTD Drug ID D0Y4QG
NDC Product Code Not Available
UNII 78846I289Y
Synonyms bedaquiline | (1R,2S)-1-(6-bromo-2-methoxy-quinolin-3-yl)-4-dimethylamino-2-(3-fluorophenyl)-1-phenyl-butan-2-ol | R207910 | TMC207 | AIDS222088 | AIDS-222089 | bedaquiline fumarate
Chemical Information
Molecular Formula C32H31BrN2O2
CAS Registry Number 843663-66-1
SMILES CN(C)CCC(C1=CC=CC2=CC=CC=C21)(C(C3=CC=CC=C3)C4=C(N=C5C=CC(=CC5=C4)Br)OC)O
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)
Nausea07.01.07.001--
Nephrotic syndrome20.05.01.0020.001027%
Nervous system disorder17.02.10.001---
Pancreatitis07.18.01.0010.001540%
Peritonitis07.19.05.004; 11.01.07.007--
Pruritus23.03.12.0010.001027%
Rash23.03.13.0010.002773%-
Rash pruritic23.03.13.0300.001027%-
Septic shock11.01.11.004; 24.06.02.011---
Sudden death02.03.04.013; 08.04.01.0030.001027%
Torsade de pointes02.03.04.005---
Vomiting07.01.07.003--
Cardiopulmonary failure02.05.01.004; 22.02.06.0040.001027%-
Musculoskeletal discomfort15.03.04.001---
Transaminases increased13.03.04.036---
Hepatic enzyme increased13.03.04.028---
Adverse event08.06.01.0100.005032%-
Cardiac disorder02.11.01.003---
Connective tissue disorder10.04.04.026; 15.06.01.006---
Mental disorder19.07.01.0020.001027%-
Decreased appetite08.01.09.028; 14.03.01.005--
Hepatobiliary disease09.01.08.003---
Renal impairment20.01.03.0100.002773%-
Treatment failure08.06.01.0170.001027%-
Drug-induced liver injury09.01.07.023; 12.03.01.0440.001027%-
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