Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Valbenazine
Drug ID BADD_D02491
Description Valbenazine (development name NBI-98854) has been used in trials studying the treatment and basic science of Tourette Syndrome and Tardive Dyskinesia. In April, 2017, valbenazine was approved by the FDA (as Ingrezza) as the first and only approved treatment for adults with Tardive Dyskinesia (TD).
Indications and Usage For the treatment of tardive dyskinesia in adults [FDA Label].
Marketing Status approved; investigational
ATC Code N07XX13
DrugBank ID DB11915
KEGG ID D10675
MeSH ID C000603978
PubChem ID 24795069
TTD Drug ID D63WMQ
NDC Product Code 47049-021; 66406-0314; 70370-2040; 70370-2048; 47049-008; 47049-009; 70370-1060; 70370-1080; 66406-0274
UNII 54K37P50KH
Synonyms valbenazine | (2R,3R,11BR)-9,10-dimethoxy-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H- benzo(a)quinolizin-2-yl l-valinate | NBI-98854 | Ingrezza | valine 1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo(a)quinolizin-2-yl ester
Chemical Information
Molecular Formula C24H38N2O4
CAS Registry Number 1025504-45-3
SMILES CC(C)CC1CN2CCC3=CC(=C(C=C3C2CC1OC(=O)C(C(C)C)N)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)
Dysarthria19.19.03.001; 17.02.08.0010.012167%
Dyskinesia17.01.02.0060.095395%
Dysphagia07.01.06.0030.024495%
Dystonia17.01.03.0010.012974%Not Available
Euphoric mood19.04.02.0060.001830%
Failure to thrive18.04.01.003; 14.03.02.008; 19.07.05.0010.000538%Not Available
Fatigue08.01.01.0020.134479%
Feeling abnormal08.01.09.0140.055719%Not Available
Feeling jittery08.01.09.0160.016743%Not Available
Flat affect19.04.01.0040.002746%Not Available
Formication17.02.06.018; 19.10.04.0020.002746%Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.0020.050282%
Hallucination19.10.04.0030.015235%
Hallucination, auditory19.10.04.0040.004576%Not Available
Hypersensitivity10.01.03.0030.028156%
Hypokinesia17.01.02.0090.003930%Not Available
Incontinence20.02.02.004; 17.05.01.006; 07.01.06.0110.009152%Not Available
Initial insomnia19.02.01.005; 17.15.03.0050.003661%Not Available
Insomnia19.02.01.002; 17.15.03.0020.053619%
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.022503%
Lip swelling10.01.05.005; 07.05.04.005; 23.04.01.0070.005760%Not Available
Listless19.04.04.003; 08.01.01.0120.001830%Not Available
Mania19.16.02.0020.006945%
Mood altered19.04.02.0070.009152%Not Available
Muscle rigidity17.05.02.005; 15.05.04.0010.008237%Not Available
Muscle twitching15.05.03.0050.008506%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.012974%
Nervousness19.06.02.0030.010067%Not Available
Neuroleptic malignant syndrome12.03.01.003; 08.05.01.005; 17.05.02.003; 15.05.04.0150.000808%Not Available
Nightmare19.02.03.0030.021319%Not Available
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