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)
Urinary retention20.02.02.0110.011521%
Urticaria23.04.02.001; 10.01.06.0010.051897%
Mental status changes19.07.01.0010.006191%Not Available
Muscle tightness15.05.03.0070.004576%Not Available
Balance disorder17.02.02.007; 08.01.03.0810.062664%Not Available
Musculoskeletal stiffness15.03.05.0270.018196%Not Available
Depressive symptom19.15.02.0030.003661%Not Available
Dysphemia19.19.03.005; 17.02.08.0100.003661%Not Available
Parkinsonian gait17.01.05.005; 08.01.02.0050.002746%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.004576%Not Available
Bipolar disorder19.16.01.0030.003015%Not Available
Major depression19.15.01.0030.000538%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.009152%Not Available
Neurological symptom17.02.05.0100.005383%Not Available
Adverse event08.06.01.0100.020673%Not Available
Eye movement disorder17.02.05.025; 06.05.02.0080.008506%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.001454%Not Available
Limb discomfort15.03.04.0140.005760%Not Available
Mental disorder19.07.01.0020.005437%Not Available
Abnormal behaviour19.01.01.0010.012974%Not Available
Psychiatric symptom19.01.02.0010.006406%Not Available
Parkinson's disease17.01.05.0100.006568%Not Available
Adverse drug reaction08.06.01.0090.141908%Not Available
Drug intolerance08.06.01.0130.064979%Not Available
Psychotic disorder19.03.01.0020.012867%
Head titubation17.01.06.0060.002746%Not Available
Substance abuse19.07.06.0180.000538%Not Available
Hypersexuality19.08.03.0050.001830%Not Available
Psychiatric decompensation19.01.02.0100.001992%Not Available
Adverse reaction08.06.01.0180.005760%Not Available
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