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)
Eye disorder06.08.03.0010.003947%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.019737%Not Available
Feeling cold08.01.09.0080.003947%Not Available
Fluid retention14.05.06.002; 20.01.02.0030.007895%Not Available
Formication19.10.02.010; 17.02.06.0180.003947%Not Available
Gait disturbance17.02.05.016; 08.01.02.0020.015790%
Galactorrhoea21.05.02.002; 05.03.04.002--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gingival pain07.09.04.0010.003947%
Glossodynia07.14.02.0010.023684%Not Available
Gynaecomastia05.05.02.003; 21.05.04.003--
Hallucination19.10.02.0020.005921%
Hallucination, auditory19.10.02.0030.003947%Not Available
Headache17.14.01.001--
Heart rate increased13.14.04.0020.017763%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.0280.007895%
Hyperprolactinaemia05.03.01.002--Not Available
Hypersensitivity10.01.03.0030.021711%
Hypersomnia19.02.05.001; 17.15.01.0010.005921%
Hypertension24.08.02.0010.009868%
Hypertriglyceridaemia14.08.02.001--
Hypoaesthesia17.02.06.0230.015790%Not Available
Hyponatraemia14.05.04.0020.005921%
Hypotension24.06.03.002--
Immune system disorder10.02.01.001--Not Available
Increased appetite14.03.01.003; 08.01.09.0270.003947%Not Available
Influenza like illness08.01.03.0100.003947%
Insomnia19.02.01.002; 17.15.03.0020.021711%
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