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%
Urticaria10.01.06.001; 23.04.02.0010.051897%
Mental status changes19.07.01.0010.006191%-
Muscle tightness15.05.03.0070.004576%-
Balance disorder08.01.03.081; 17.02.02.0070.062664%-
Musculoskeletal stiffness15.03.05.0270.018196%-
Depressive symptom19.15.02.0030.003661%-
Dysphemia17.02.08.010; 19.19.03.0050.003661%-
Parkinsonian gait08.01.02.005; 17.01.05.0050.002746%-
Paraesthesia oral07.05.05.035; 17.02.06.0080.004576%-
Bipolar disorder19.16.01.0030.003015%-
Major depression19.15.01.0030.000538%-
Restless legs syndrome15.05.03.012; 17.02.07.0080.009152%-
Neurological symptom17.02.05.0100.005383%-
Adverse event08.06.01.0100.020673%-
Eye movement disorder06.05.02.008; 17.02.05.0250.008506%-
Feeding disorder14.03.02.003; 19.09.01.0030.001454%-
Limb discomfort15.03.04.0140.005760%-
Mental disorder19.07.01.0020.005437%-
Abnormal behaviour19.01.01.0010.012974%-
Psychiatric symptom19.01.02.0010.006406%-
Parkinson's disease17.01.05.0100.006568%-
Adverse drug reaction08.06.01.0090.141908%-
Drug intolerance08.06.01.0130.064979%-
Psychotic disorder19.03.01.0020.012867%
Head titubation17.01.06.0060.002746%-
Substance abuse19.07.06.0180.000538%-
Hypersexuality19.08.03.0050.001830%-
Psychiatric decompensation19.01.02.0100.001992%-
Adverse reaction08.06.01.0180.005760%-
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