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)
Acute hepatic failure09.01.03.0010.001540%-
Alanine aminotransferase increased13.03.04.005--
Alcohol poisoning12.03.01.017; 19.07.06.002---
Amylase increased13.05.01.009--
Arrhythmia02.03.02.0010.001027%-
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Condition aggravated08.01.03.0040.001027%-
Constipation07.02.02.0010.002259%
Death08.04.01.0010.004108%
Depression19.15.01.0010.002259%
Dermatitis23.03.04.002---
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.003286%
Drug interaction08.06.03.0010.002259%-
Dysphagia07.01.06.0030.004005%
Electrocardiogram QT prolonged13.14.05.004--
Gastrointestinal disorder07.11.01.001---
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.006---
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.001---
Hepatic function abnormal09.01.02.001---
Hepatitis09.01.07.004---
Hepatocellular injury09.01.07.0080.002567%-
Hepatotoxicity09.01.07.009; 12.03.01.0080.020539%-
Hypokalaemia14.05.03.0020.001027%
Iridocyclitis06.04.03.0010.001027%-
Myalgia15.05.02.001--
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