Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Asenapine maleate
Drug ID BADD_D00173
Description Developed by Schering-Plough after its merger with Organon International, asenapine is a sublingually administered, atypical antipsychotic for treatment of schizophrenia and acute mania associated with bipolar disorder. Asenapine also belongs to the dibenzo-oxepino pyrrole class. It is also for severe post-traumatic stress disorder nightmares in soldiers as an off-label use. FDA approved on August 13, 2009.
Indications and Usage Used for treatment in psychosis, schizophrenia and schizoaffective disorders, manic disorders, and bipolar disorders as monotherapy or in combination.
Marketing Status Prescription
ATC Code N05AH05
DrugBank ID DB06216
KEGG ID D02995
MeSH ID C522667
PubChem ID 163091
TTD Drug ID D00JRA
NDC Product Code 51991-361; 55111-937; 60870-0468; 0456-2407; 51991-358; 69539-058; 69539-060; 62938-0040; 51991-360; 46708-916; 50379-0004; 50379-0009; 16436-0104; 51991-359; 0456-2402; 17337-0309; 59762-2012; 69539-057; 0456-2412; 65015-817; 62938-0017; 53296-0104; 0456-2404; 59762-1091; 62938-0041; 59762-2888; 0456-2410; 69539-059; 62938-0016; 0456-2405; 51991-928; 69539-245; 64330-625
Synonyms asenapine | trans-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz(2,3:6,7)oxepino(4,5-c)pyrrole | asenapine maleate | ORG 5222 | ORG-5222 | 5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz(2,3-6,7)oxepino(4,5-c)pyrrole | Secuado | Saphris
Chemical Information
Molecular Formula C17H16ClNO
CAS Registry Number 65576-45-6
SMILES CN1CC2C(C1)C3=C(C=CC(=C3)Cl)OC4=CC=CC=C24
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
Akathisia19.06.02.006; 17.01.02.002--
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Bipolar I disorder19.16.01.002--Not Available
Blister23.03.01.001; 12.01.06.002--Not Available
Constipation07.02.02.001--
Depression19.15.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Extrapyramidal disorder17.01.02.007--
Fatigue08.01.01.002--
Headache17.14.01.001--
Hypertension24.08.02.001--
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Irritability19.04.02.013; 08.01.03.011--
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.011--
Pain in extremity15.03.04.010--
Salivary hypersecretion07.06.01.009--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Suicidal ideation19.12.01.003--
Toothache07.09.06.001--
Ulcer08.03.06.001--Not Available
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Hypoaesthesia oral17.02.06.021; 07.05.05.003--Not Available
Inflammation08.01.05.007--Not Available
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