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--Not Available
Pancreatitis07.18.01.0010.001540%
Peritonitis11.01.07.007; 07.19.05.004--
Pruritus23.03.12.0010.001027%
Rash23.03.13.0010.002773%Not Available
Rash pruritic23.03.13.0300.001027%Not Available
Septic shock24.06.02.011; 11.01.11.004--Not Available
Sudden death08.04.01.003; 02.03.04.0130.001027%
Torsade de pointes02.03.04.005--Not Available
Vomiting07.01.07.003--
Cardiopulmonary failure22.02.06.004; 02.05.01.0040.001027%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Transaminases increased13.03.04.036--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Adverse event08.06.01.0100.005032%Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Mental disorder19.07.01.0020.001027%Not Available
Decreased appetite08.01.09.028; 14.03.01.005--
Hepatobiliary disease09.01.08.003--Not Available
Renal impairment20.01.03.0100.002773%Not Available
Treatment failure08.06.01.0170.001027%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.001027%Not Available
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