Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bedaquiline fumarate
Drug ID BADD_D00222
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 D09873
MeSH ID C493870
PubChem ID 24812732
TTD Drug ID D0Y4QG
NDC Product Code 59676-701; 59676-702; 69766-058
UNII P04QX2C1A5
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 C36H35BrN2O6
CAS Registry Number 845533-86-0
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.C(=CC( =O)O)C(=O)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)
Alanine aminotransferase13.03.04.002--Not Available
Alanine aminotransferase increased13.03.04.005--
Amylase increased13.05.01.009--
Arthralgia15.01.02.001--
Aspartate aminotransferase13.03.04.008--Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Death08.04.01.001--
Drug interaction08.06.03.001--Not Available
Electrocardiogram QT prolonged13.14.05.004--
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.004--Not Available
Headache17.14.01.001--
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Nausea07.01.07.001--
Rash23.03.13.001--Not Available
Transaminases increased13.03.04.036--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
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