Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Aripiprazole lauroxil
Drug ID BADD_D00166
Description Aripiprazole lauroxil is a long-acting injectable atypical antipsychotic drug used in the treatment of schizophrenia in adult patients. It is a prodrug of [aripiprazole], which acts as a partial agonist at the D2 and 5-HT1A receptors, and as an antagonist at the 5-HT2A receptors [A34289]. Affecting about 1% of the adult population in the United States and approximately 26 million people worldwide, schizophrenia is a chronic neurological disorder that may result in impairments in cognition and executive functions [A34289]. The quality of life in patients is greatly reduced due to negative health outcomes, and oftentimes the patients are faced with social stigma and discriminations. Schizophrenia is characterized by positive symptoms such as delusions, hallucinations, thought disorders, and catanoia, and negative symptoms that include social withdrawal, anhedonia, and flattening of emotional responses [T28]. D2 receptors have been the most common target for antipsychotic agents used in the treatment of schizophrenia: the positive symptoms are thought to arise from overactivity in the mesolimbic dopaminergic pathway activating D2 receptors, whereas negative symptoms may result from a decreased activity in the mesocortical dopaminergic pathway with D1 receptors predominating [T28]. In a randomized, double-blind clinical trial, treatment of aripiprazole lauroxil in adult patients with schizophrenia resulted in improvement of positive and negative symptoms scores at day 85 of treatment [A34289, A34301]. Aripiprazole lauroxil was initially approved by the FDA in October 2015 under the market name Aristada for the treatment of schizophrenia. It is administered via intramuscular injection, and requires the establishment of tolerability prior to dosing in treatment-naïve patients [FDA Label]. On July 2nd, a different formulation of aripiprazole lauroxil marketed as Aristada Initio was FDA-approved for immediate initiation of Aristada at any dose. The patients may receive Aristada Initio in combination with a single 30 mg oral dose of aripiprazole to achieve appropriate levels of aripiprazole more rapidly. Long-acting injectable aripiprazole lauroxil displayed comparable efficacy and safety to aripiprazole [A34301], and reduced dosing frequency improves patient adherence.
Indications and Usage For the treatment of schizophrenia and related psychotic disorders.
Marketing Status Prescription
ATC Code N05AX12
DrugBank ID DB14185
KEGG ID D10364
MeSH ID C000603935
PubChem ID 49831411
TTD Drug ID Not Available
NDC Product Code 65757-404; 65757-500; 65757-403; 59116-5070; 65757-401; 65757-402; 69037-0045; 58032-1020; 64552-4079
Synonyms aripiprazole lauroxil | Aristada
Chemical Information
Molecular Formula C36H51Cl2N3O4
CAS Registry Number 1259305-29-7
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; Available
Aggression19.05.01.001-Not Available
Akinesia17.01.02.003--Not Available
Alcohol abuse19.07.02.007-Not Available
Anaphylactic reaction10.01.07.001;
Anger19.04.02.001-Not Available
Angina pectoris24.04.04.002;
Angioedema23.04.01.001; Available
Apathy19.04.04.002-Not Available
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.002--
Atrial flutter02.03.03.003--
Atrioventricular block02.03.01.002--Not Available
Back pain15.03.04.005-
Blindness transient17.17.01.004; Available
Blood bilirubin increased13.03.01.008--
Blood cholesterol increased13.12.01.002-
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.004--
Blood glucose abnormal13.02.02.008-Not Available
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