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)
Oral pain07.05.03.0020.003947%
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Osteoarthritis15.01.04.001--Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pain in jaw15.02.01.0030.003947%Not Available
Panic attack19.06.04.0010.003947%Not Available
Panic reaction19.06.04.0030.003947%Not Available
Paraesthesia17.02.06.0050.011842%
Paranoia19.05.01.0050.003947%Not Available
Parkinsonism17.01.05.003--Not Available
Pharyngeal oedema23.04.01.016; 22.04.05.003; 10.01.05.0160.019737%Not Available
Polyuria20.02.03.0020.003947%Not Available
Pregnancy18.08.02.004--Not Available
Presyncope24.06.02.010; 17.02.05.009; 02.01.02.0070.003947%
Pruritus23.03.12.001--
Psychomotor hyperactivity19.11.02.003; 17.01.02.0110.003947%Not Available
Pulmonary embolism22.06.02.001; 24.01.06.001--Not Available
Rash23.03.13.0010.047369%Not Available
Rash erythematous23.03.06.0030.003947%Not Available
Rash pruritic23.03.12.0020.003947%Not Available
Respiratory disorder22.02.07.0020.003947%Not Available
Restlessness19.11.02.002; 17.02.05.0210.009868%
Rhabdomyolysis15.05.05.0020.003947%
Salivary hypersecretion07.06.01.009--Not Available
Schizophrenia19.03.04.001--Not Available
Screaming19.19.03.0070.003947%Not Available
Sedation17.02.04.0050.027632%Not Available
Seizure17.12.03.0010.011842%
Serotonin syndrome12.03.01.041; 17.05.02.004; 15.05.04.0160.003947%Not Available
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