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 Prescription
ATC Code J04AK05
DrugBank ID DB08903
KEGG ID D09873
MeSH ID C493870
PubChem ID 24812732
TTD Drug ID D0Y4QG
NDC Product Code 59676-702; 59676-701; 69766-058
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
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Alanine aminotransferase13.03.01.031--Not Available
Alanine aminotransferase increased13.03.01.003--
Amylase increased13.05.01.009--
Arthralgia15.01.02.001--
Aspartate aminotransferase13.03.01.032--Not Available
Chest pain02.02.02.011; 08.01.08.002; 22.02.08.003--Not Available
Death08.04.01.001--
Drug interaction08.06.03.001--Not Available
Electrocardiogram QT prolonged13.14.05.004--
Haemoptysis02.01.02.006; 22.02.03.004; 24.07.01.006--Not Available
Headache17.14.01.001--
Hepatotoxicity09.01.07.009; 12.03.01.008--Not Available
Nausea07.01.07.001--
Rash23.03.13.001--Not Available
Transaminases increased13.03.01.015--Not Available
Decreased appetite08.01.09.028; 14.03.01.005--
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