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 approved; investigational
ATC Code N07XX16
DrugBank ID DB12161
KEGG ID D10701
MeSH ID C000609690
PubChem ID 73437646
TTD Drug ID D0E7ZU
NDC Product Code 59651-496; 68546-170; 68546-176; 53183-4062; 58032-2022; 68546-172; 68546-471; 68546-470; 68546-182; 68546-472; 68546-171; 68546-490; 65977-0123; 70600-025
UNII P341G6W9NB
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
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)
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.0140.001184%-
Tardive dyskinesia17.01.02.0120.006352%-
Therapeutic response unexpected08.06.01.0010.002746%-
Tic17.02.05.024; 19.11.04.0010.004199%-
Tongue movement disturbance07.14.02.016; 17.02.05.0490.002746%-
Tremor17.01.06.0020.022018%
Trismus15.05.04.004; 17.01.03.0040.003015%
Urinary retention20.02.02.0110.000538%
Visual impairment06.02.10.0130.003015%-
Mental status changes19.07.01.0010.001454%-
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.001830%-
Muscle tightness15.05.03.0070.001830%-
Balance disorder08.01.03.081; 17.02.02.0070.003284%-
Morbid thoughts19.10.03.0040.001830%-
Self-injurious ideation19.12.01.0070.001184%-
Cardiac flutter02.03.02.0120.001184%-
Musculoskeletal stiffness15.03.05.0270.002369%-
Dysphemia17.02.08.010; 19.19.03.0050.001830%-
Cognitive disorder17.03.03.003; 19.21.02.0010.003284%
Restless legs syndrome15.05.03.012; 17.02.07.0080.002746%-
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.0050.001830%
Adverse event08.06.01.0100.003284%-
Cardiac disorder02.11.01.0030.002746%-
Feeding disorder14.03.02.003; 19.09.01.0030.003015%-
Motor dysfunction15.05.06.006; 17.01.02.0310.000538%-
Abnormal behaviour19.01.01.0010.002100%-
Parkinson's disease17.01.05.0100.000808%-
Adverse drug reaction08.06.01.0090.005114%-
Drug intolerance08.06.01.0130.004576%-
Psychotic disorder19.03.01.0020.003553%
The 4th Page    First    Pre   4 5    Next   Last    Total 5 Pages