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)
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Shock24.06.02.002--Not Available
Sinus bradycardia02.03.03.009--
Sinus tachycardia02.03.03.010--
Skin exfoliation23.03.07.003--Not Available
Skin reaction23.03.03.013; 10.01.03.0190.003947%Not Available
Somnambulism19.02.03.006; 17.15.02.0040.003947%Not Available
Somnolence19.02.05.003; 17.02.04.0060.037500%
Speech disorder19.19.02.002; 17.02.08.003; 22.02.05.0340.011842%Not Available
Stomatitis07.05.06.0050.003947%
Suicidal ideation19.12.01.0030.013816%
Swelling08.01.03.0150.007895%Not Available
Swelling face23.04.01.018; 10.01.05.0180.015790%Not Available
Swollen tongue07.14.02.003; 23.04.01.014; 10.01.05.0150.057237%Not Available
Syncope24.06.02.012; 17.02.04.008; 02.01.02.0080.007895%
Tachycardia02.03.02.0070.007895%Not Available
Tardive dyskinesia17.01.02.0120.011842%Not Available
Thinking abnormal17.02.05.023; 19.10.03.0010.003947%Not Available
Throat irritation22.02.05.013; 07.05.03.0040.005921%Not Available
Throat tightness19.01.02.005; 22.02.05.0150.005921%Not Available
Thrombocytopenia01.08.01.002--Not Available
Tongue disorder07.14.01.0020.005921%Not Available
Tongue ulceration07.14.01.0030.007895%Not Available
Tooth discolouration07.09.02.0010.005921%
Toothache07.09.06.0010.005921%
Torticollis17.01.03.003; 15.05.04.0030.003947%Not Available
Tremor17.01.06.0020.019737%
Ulcer08.03.06.001--Not Available
Unresponsive to stimuli17.02.05.0310.007895%Not Available
Urticaria23.04.02.001; 10.01.06.001--
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