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 Prescription
ATC Code J04AK05
DrugBank ID DB08903
KEGG ID D09872
MeSH ID C493870
PubChem ID 5388906
TTD Drug ID D0Y4QG
NDC Product Code Not Available
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
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Acute hepatic failure09.01.03.0010.006887%Not Available
Alanine aminotransferase increased13.03.01.003--
Alcohol poisoning12.03.01.017--Not Available
Amylase increased13.05.01.009--
Arrhythmia02.03.02.0010.004591%Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.01.006--
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chest pain02.02.02.011; 08.01.08.002; 22.02.08.003--Not Available
Death08.04.01.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.0070.006887%
Electrocardiogram QT prolonged13.14.05.0040.050501%
Electrolyte imbalance14.05.01.0020.013773%Not Available
Gastrointestinal disorder07.11.01.0010.004591%Not Available
Haemoptysis02.01.02.006; 22.02.03.004; 24.07.01.006--Not Available
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.001--Not Available
Hepatic function abnormal09.01.02.001--Not Available
Hepatitis09.01.07.004--Not Available
Hepatocellular injury09.01.07.0080.011478%Not Available
Hepatotoxicity09.01.07.009; 12.03.01.0080.103298%Not Available
Hypokalaemia14.05.03.0020.004591%
Myalgia15.05.02.001--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Peritonitis07.19.05.004; 11.01.07.007--
Rash23.03.13.0010.004591%Not Available
Septic shock11.01.11.004; 24.06.02.011--Not Available
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