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%Not Available
Alanine aminotransferase increased13.03.04.005--
Alcohol poisoning19.07.06.002; 12.03.01.017--Not Available
Amylase increased13.05.01.009--
Arrhythmia02.03.02.0010.001027%Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Condition aggravated08.01.03.0040.001027%Not Available
Constipation07.02.02.0010.002259%
Death08.04.01.0010.004108%
Depression19.15.01.0010.002259%
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.003286%
Drug interaction08.06.03.0010.002259%Not Available
Dysphagia07.01.06.0030.004005%
Electrocardiogram QT prolonged13.14.05.004--
Gastrointestinal disorder07.11.01.001--Not Available
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.004--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 injury09.01.07.0080.002567%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.020539%Not Available
Hypokalaemia14.05.03.0020.001027%
Iridocyclitis06.04.03.0010.001027%Not Available
Myalgia15.05.02.001--
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