Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lumateperone
Drug ID BADD_D02565
Description Schizophrenia is a complex mental illness and impacts approximately 1% of the population.[L10902] Although there are several antipsychotics including [aripiprazole], [paliperidone] and [clozapine] available for clinical use, they are generally accompanied by significant metabolic and/or neurological adverse effects.[A189093] Lumateperone is a newly approved 2nd generation antipsychotic currently indicated for the treatment of schizophrenia.[A189093] It has a unique receptor binding profile and differs from other antipsychotics in that it modulates glutamate, serotonin and dopamine, which are all neurotransmitters that contribute to the pathophysiology of schizophrenia.[A189093,A189174] The data so far indicates that lumateperone can alleviate both positive and negative symptoms of schizophrenia.[A189093] Further, not only is the new antipsychotic selective for dopamine (D2) receptors in the mesolimbic and mesocortical brain regions, but it also has minimal off-target activity.[A189093] Both characteristics lend to a more favourable adverse effect profile and ultimately safer drug.[A189093,L10908]
Indications and Usage Lumateperone is approved for the treatment of schizophrenia in adults.[L10860]
Marketing Status approved; investigational
ATC Code N05AD10
DrugBank ID DB06077
KEGG ID D11169
MeSH ID C000705749
PubChem ID 21302490
TTD Drug ID D1CWL0
NDC Product Code 72060-142; 72060-110; 70518-3497; 66406-0300; 72060-121
UNII 70BSQ12069
Synonyms lumateperone | ITI-007 | ITI-722 | lumateperone tosylate
Chemical Information
Molecular Formula C24H28FN3O
CAS Registry Number 313369-37-8
SMILES CN1CCN2C3CCN(CC3C4=C2C1=CC=C4)CCCC(=O)C5=CC=C(C=C5)F
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)
Vomiting07.01.07.0030.006703%
Withdrawal syndrome08.06.02.012; 19.07.06.0230.000444%-
Performance status decreased08.01.03.0420.001751%-
Muscle fatigue15.05.03.0060.000666%-
Muscle tightness15.05.03.0070.000666%-
Balance disorder08.01.03.081; 17.02.02.0070.000889%-
Dysstasia08.01.03.089; 15.03.05.011; 17.02.02.0120.000287%-
Musculoskeletal stiffness15.03.05.0270.000575%-
Skin burning sensation17.02.06.009; 23.03.03.0210.003528%-
Dysphemia17.02.08.010; 19.19.03.0050.000510%-
Paraesthesia oral07.05.05.035; 17.02.06.0080.000287%-
Bipolar disorder19.16.01.0030.000287%-
Cognitive disorder17.03.03.003; 19.21.02.0010.000287%
Restless legs syndrome15.05.03.012; 17.02.07.0080.000444%-
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.0050.000510%
Eye movement disorder06.05.02.008; 17.02.05.0250.000666%-
Temperature regulation disorder05.03.04.013; 08.05.01.0040.001176%-
Psychotic disorder19.03.01.0020.000941%
Unevaluable event08.01.03.0510.002548%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.000287%
Tachyphrenia17.03.03.007; 19.10.03.0100.000444%-
Electric shock sensation08.06.02.023; 17.02.07.0240.000666%-
Gait inability08.01.02.011; 17.02.05.0690.000444%-
Psychotic symptom19.03.01.0120.000131%-
Therapeutic product effect incomplete08.06.01.0520.000797%-
Therapeutic response shortened08.06.01.0620.000444%-
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