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
TTD Drug ID D0E7ZU
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
SMILES CC(C)CC1CN2CCC3=CC(=C(C=C3C2CC1=O)OC)OC
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)
Nightmare19.02.03.0030.003921%Not Available
Ocular hyperaemia06.04.05.0040.002614%Not Available
Pain08.01.08.004--
Palpitations02.01.02.0030.003921%
Panic attack19.06.04.0010.002614%Not Available
Paraesthesia17.02.06.005--
Paranoia19.05.01.0050.003921%Not Available
Parkinsonism17.01.05.0030.005229%Not Available
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Restlessness19.11.02.002; 17.02.05.0210.006536%
Rhinorrhoea22.02.05.0100.002614%
Seizure17.12.03.001--
Somnolence19.02.05.003; 17.02.04.0060.023529%
Speech disorder22.02.05.034; 19.19.02.002; 17.02.08.0030.005229%Not Available
Suicidal ideation19.12.01.0030.014379%
Suicide attempt19.12.01.0040.003921%
Tachycardia02.03.02.0070.002614%Not Available
Tardive dyskinesia17.01.02.0120.007843%Not Available
Tic19.11.04.001; 17.02.05.0240.002614%Not Available
Tremor17.01.06.0020.024836%
Visual impairment06.02.06.0080.003921%Not Available
Vomiting07.01.07.0030.009150%
Weight decreased13.15.01.005--
Weight increased13.15.01.0060.009150%
Peripheral swelling08.01.03.053; 02.05.04.0150.002614%Not Available
Abasia17.02.05.035; 08.01.02.0070.002614%Not Available
Muscle tightness15.05.03.0070.002614%Not Available
Balance disorder17.02.02.0070.002614%Not Available
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