Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cariprazine
Drug ID BADD_D00369
Description Cariprazine is an antipsychotic drug developed by Gedeon Richter and marketed by Actavis under the trade name Vraylar. Cariprazine acts as a D2 and D3 receptor partial agonist, with high selectivity towards the D3 receptor. This mechanism is relatively unique, since many other antipsychotics are D2 and 5-HT2A agonists. Cariprazine was approved by the FDA in September 2015 and is indicated in the treatment of schizophrenia and bipolar disorder. Action on the dopaminergic systems makes it also potentially useful as an add-on therapy in major depressive disorder.
Indications and Usage Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder.
Marketing Status approved; investigational
ATC Code N05AX15
DrugBank ID DB06016
KEGG ID D09997
MeSH ID C533287
PubChem ID 11154555
TTD Drug ID D05XGO
NDC Product Code 61874-145; 61874-170; 70518-3157; 61874-161; 61874-116; 61874-131; 61874-115; 61874-160; 61874-146; 61874-130
UNII F6RJL8B278
Synonyms cariprazine | 3-(trans-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-1,1-dimethylurea | Vraylar | cariprazine hydrochloride | N'-(trans-4-(2-(4-(2,3-dichlorophenyl)piperazin-1-yl)ethyl)cyclohexyl)-N,N-dimethylurea monohydrochloride | cariprazine HCl | trans-4-(2-(4-(2,3-dichlorophenyl)piperazine-1-yl)-ethyl)-N,N-dimethylcarbamoyl-cyclohexyl-amine hydrochloride | RGH-188
Chemical Information
Molecular Formula C21H32Cl2N4O
CAS Registry Number 839712-12-8
SMILES CN(C)C(=O)NC1CCC(CC1)CCN2CCN(CC2)C3=C(C(=CC=C3)Cl)Cl
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)
Tongue movement disturbance07.14.02.016; 17.02.05.0490.000444%-
Toothache07.09.06.001--
Tremor17.01.06.0020.007304%
Trismus15.05.04.004; 17.01.03.0040.000444%
Urinary retention20.02.02.0110.000954%
Urinary tract infection11.01.14.004; 20.08.02.001--
Vertigo04.04.01.003; 17.02.12.0020.000889%
Vision blurred06.02.06.007; 17.17.01.0100.003175%
Vomiting07.01.07.0030.004129%
Weight increased13.15.01.006--
Withdrawal syndrome08.06.02.012; 19.07.06.0230.000889%-
Peripheral swelling02.05.04.015; 08.01.03.0530.001333%-
Homicidal ideation19.05.01.0080.000131%-
Musculoskeletal stiffness15.03.05.0270.000954%-
Depressive symptom19.15.02.0030.000444%-
Affect lability19.04.01.0010.000444%-
Transaminases increased13.03.04.036---
Bipolar disorder19.16.01.0030.000444%-
Restless legs syndrome15.05.03.012; 17.02.07.0080.001777%-
Hepatic enzyme increased13.03.04.028---
Eye movement disorder06.05.02.008; 17.02.05.0250.000510%-
Ischaemic stroke17.08.01.018; 24.04.06.010---
Decreased appetite08.01.09.028; 14.03.01.005--
Erectile dysfunction19.08.04.001; 21.03.01.0070.000666%
Psychotic disorder19.03.01.0020.000993%
Facial spasm17.04.03.0100.000666%-
Head titubation17.01.06.0060.000287%-
Suicidal behaviour19.12.01.0060.000131%-
Hypersexuality19.08.03.0050.000510%-
Oropharyngeal pain07.05.05.004; 22.12.03.016--
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