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)
Sedation17.02.04.0050.003240%Not Available
Seizure17.12.03.001--
Serotonin syndrome17.05.02.004; 15.05.04.016; 12.03.01.0410.000131%Not Available
Sexual dysfunction21.03.02.003; 19.08.05.0020.000666%Not Available
Sinus bradycardia02.03.03.0090.000444%
Sjogren's syndrome15.06.01.015; 10.04.04.009; 07.06.01.010; 06.08.02.0110.000131%Not Available
Sleep disorder19.02.04.0010.000575%Not Available
Somnambulism17.15.02.004; 19.02.03.0060.000444%Not Available
Somnolence19.02.05.003; 17.02.04.0060.002522%
Speech disorder22.12.03.027; 17.02.08.003; 19.19.02.0020.000353%Not Available
Stevens-Johnson syndrome23.03.01.007; 12.03.01.014; 11.07.01.005; 10.01.01.0450.000131%
Suicidal ideation19.12.01.0030.002208%
Suicide attempt19.12.01.0040.000719%
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.018--Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.000483%Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tardive dyskinesia17.01.02.0120.005135%Not Available
Therapeutic response unexpected08.06.01.0010.001241%Not Available
Thinking abnormal19.10.03.001; 17.02.05.0230.000444%Not Available
Thirst14.03.02.007; 08.01.09.0210.000444%Not Available
Throat tightness22.12.03.031; 19.01.02.0050.000444%Not Available
Tic17.02.05.024; 19.11.04.0010.000444%Not Available
Tongue movement disturbance07.14.02.016; 17.02.05.0490.000510%Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.0010.000196%
Tremor17.01.06.0020.007722%
Urinary retention20.02.02.0110.000614%
Urinary tract infection20.08.02.001; 11.01.14.004--
Vision blurred17.17.01.010; 06.02.06.0070.002130%
Weight increased13.15.01.006--
Wheezing22.03.01.0090.000666%
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