Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Brexpiprazole
Drug ID BADD_D00293
Description Brexpiprazole is a novel D2 dopamine and serotonin 1A partial agonist, called serotonin-dopamine activity modulator (SDAM), and a potent antagonist of serotonin 2A receptors, noradrenergic alpha 1B and 2C receptors. Brexpiprazole is approved for the treatment of schizophrenia, and as an adjunctive treatment for major depressive disorder (MDD). Although it failed Phase II clinical trials for ADHD, it has been designed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia) over established adjunctive treatments for major depressive disorder (MDD).
Indications and Usage As an adjunctive treatment of major depressive disorder (MDD) and for treatment of schizophrenia.
Marketing Status approved; investigational
ATC Code N05AX16
DrugBank ID DB09128
KEGG ID D10309
MeSH ID C000591922
PubChem ID 11978813
TTD Drug ID D0P0OU
NDC Product Code 46602-0040; 60274-935; 59148-044; 60274-937; 60274-938; 59148-036; 76055-0040; 59148-040; 60219-1653; 60219-1654; 46602-0035; 53747-084; 60274-940; 65372-1201; 27241-208; 59148-035; 59148-038; 59148-039; 59651-328; 60274-936; 60219-1649; 60274-939; 69037-0035; 27241-209; 59148-037; 60219-1650; 60219-1651; 46602-0036; 46602-0038; 46602-0039; 69766-041; 27241-205; 27241-206; 27241-207; 70518-3548; 12658-0501; 46602-0037; 59148-042; 60219-1652; 65129-1401; 27241-204
UNII 2J3YBM1K8C
Synonyms brexpiprazole | 7-(4-(4-(1-benzothiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1H)-one | Rexulti
Chemical Information
Molecular Formula C25H27N3O2S
CAS Registry Number 913611-97-9
SMILES C1CN(CCN1CCCCOC2=CC3=C(C=C2)C=CC(=O)N3)C4=C5C=CSC5=CC=C4
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)
Mental status changes19.07.01.0010.000196%Not Available
Muscle tightness15.05.03.0070.001111%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.001111%Not Available
Musculoskeletal stiffness15.03.05.0270.002483%Not Available
Food craving19.09.01.010; 14.03.01.0090.001999%Not Available
Bipolar disorder19.16.01.0030.000575%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.001620%
Metabolic disorder14.11.01.001--Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.001999%Not Available
Adverse event08.06.01.0100.005436%Not Available
Eye movement disorder06.05.02.008; 17.02.05.0250.001241%Not Available
Motor dysfunction17.01.02.031; 15.05.06.006--Not Available
Abnormal behaviour19.01.01.0010.000706%Not Available
Psychiatric symptom19.01.02.0010.000196%Not Available
Ill-defined disorder08.01.03.0490.000457%Not Available
Parkinson's disease17.01.05.0100.000327%Not Available
Adverse drug reaction08.06.01.0090.002221%Not Available
Disease recurrence08.01.03.0500.000706%Not Available
Drug intolerance08.06.01.013--Not Available
Psychotic disorder19.03.01.0020.001150%
Poor quality sleep19.02.05.005; 17.15.04.0020.000510%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.000287%Not Available
Suicidal behaviour19.12.01.0060.000327%Not Available
Psychiatric decompensation19.01.02.0100.000418%Not Available
Adverse reaction08.06.01.0180.000131%Not Available
Compulsive shopping19.06.05.0040.000510%Not Available
Slow speech19.19.02.004; 17.02.08.0160.000131%Not Available
Body temperature abnormal13.15.01.030--Not Available
Gambling disorder19.07.06.0150.000797%Not Available
Persecutory delusion19.10.01.0070.000131%Not Available
The 6th Page    First    Pre   6 7    Next   Last    Total 7 Pages