Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Deutetrabenazine
Drug ID BADD_D02507
Description Deutetrabenazine is a novel, highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the management of chorea associated with Huntington’s disease. It is a hexahydro-dimethoxybenzoquinolizine derivative and a deuterated [DB04844] [A32046]. The presence of deuterium in deutetrabenazine increases the half-lives of the active metabolite and prolongs their pharmacological activity by attenuating CYP2D6 metabolism of the compound [A32046]. This allows less frequent dosing and a lower daily dose with improvement in tolerability [A32043]. Decreased plasma fluctuations of deutetrabenazine due to attenuated metabolism may explain a lower incidence of adverse reactions associated with deutetrabenazine [A32042]. Deutetrabenazine is a racemic mixture containing RR-Deutetrabenazine and SS-Deutetrabenazine [FDA Label]. Huntington's disease (HD) is a hereditary, progressive neurodegenerative disorder characterized by motor dysfunction, cognitive decline, and neuropsychiatric disturbances [A32043] that interfere with daily functioning and significantly reduce the quality of life. The most prominent physical symptom of HD that may increase the risk of injury is chorea, which is an involuntary, sudden movement that can affect any muscle and flow randomly across body regions [A32046]. Psychomotor symptoms of HD, such as chorea, are related to hyperactive dopaminergic neurotransmission [A14081]. Deutetrabenazine depletes the levels of presynaptic dopamine by blocking VMAT2, which is responsible for the uptake of dopamine into synaptic vesicles in monoaminergic neurons and exocytotic release [A14081]. As with other agents for the treatment of neurodegenerative diseases, deutetrabenazine is a drug to alleviate the motor symptoms of HD and is not proposed to halt the progression of the disease [T28]. In clinical trials of patients with HD, 12 weeks of treatment of deutetrabenazine resulted in overall improvement in mean total maximal chorea scores and motor signs than placebo [A32046]. It was approved by FDA in April 2017 and is marketed under the trade name Austedo as oral tablets.
Indications and Usage Indicated for the treatment of chorea associated with Huntington’s disease [FDA Label].
Marketing Status Not Available
ATC Code N07XX16
DrugBank ID DB12161
KEGG ID D10701
MeSH ID C000609690
PubChem ID 73437646
NDC Product Code 68546-177; 68546-170; 53183-4062; 68546-172; 58032-2022; 59651-496; 68546-171; 65977-0123; 68546-176; 68546-181; 68546-182; 70600-025
Synonyms deutetrabenazine | Austedo
Chemical Information
Molecular Formula C19H27NO3
CAS Registry Number 1392826-25-3
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abnormal dreams19.02.03.001; Available
Aggression19.05.01.0010.006536%Not Available
Arrhythmia02.03.02.0010.003921%Not Available
Asthenia08.01.01.0010.007843%Not Available
Blood pressure increased13.14.03.0050.005229%Not Available
Cardiovascular disorder24.03.02.009; Available
Cerebrovascular accident24.03.05.001;
Chest pain22.02.08.003;; Available
Cholelithiasis09.03.01.0020.002614%Not Available
Chorea17.01.01.0010.002614%Not Available
Confusional state19.13.01.001;
Drooling17.02.05.0050.005229%Not Available
Dry eye06.08.02.0010.002614%
Dry mouth07.06.01.0020.003921%
Dystonia17.01.03.0010.002614%Not Available
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