Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Asenapine
Drug ID BADD_D00172
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 D11769
MeSH ID C522667
PubChem ID 9903970
TTD Drug ID D00JRA
NDC Product Code 68968-0172; 62332-544; 42794-016; 62332-199; 46708-199; 42794-017; 46708-544; 68968-0173; 46708-198; 62332-198; 68968-0174
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
Accommodation disorder06.02.04.001--Not Available
Acne23.02.01.0010.005921%Not Available
Ageusia17.02.07.001; 07.14.03.0030.009868%Not Available
Agitation19.06.02.001; 17.02.05.0120.017763%
Agranulocytosis01.02.03.001--Not Available
Akathisia19.06.02.006; 17.01.02.0020.011842%
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Amenorrhoea05.05.01.002; 21.01.02.0010.005921%
Amnesia19.20.01.001; 17.03.02.0010.007895%
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.0010.005921%
Anaphylactic shock24.06.02.004; 10.01.07.0020.003947%Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angioedema23.04.01.001; 10.01.05.0090.013816%Not Available
Anxiety19.06.02.0020.023684%
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Binge eating19.09.01.0010.003947%Not Available
Blister23.03.01.001; 12.01.06.002--Not Available
Blood cholesterol increased13.12.01.002--
Blood glucose increased13.02.02.0020.011842%Not Available
Blood pressure decreased13.14.03.0020.003947%Not Available
Blood pressure increased13.14.03.0050.009868%Not Available
Blood prolactin increased13.10.03.002--Not Available
Blood triglycerides increased13.12.03.001--Not Available
Bundle branch block02.03.01.009--Not Available
Cardiac arrest02.03.04.001--
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