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 approved
ATC Code N05AH05
DrugBank ID DB06216
KEGG ID D11769
MeSH ID C522667
PubChem ID 9903970
TTD Drug ID D00JRA
NDC Product Code 62332-198; 42794-017; 62332-199; 68968-0174; 68968-0173; 46708-198; 46708-199; 42794-016; 68968-0172; 62332-544; 46708-544
UNII JKZ19V908O
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Weight increased13.15.01.006--
Wheezing22.03.01.0090.001895%
Left ventricular hypertrophy02.04.02.0140.001895%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.000861%Not Available
Idiosyncratic drug reaction08.06.01.002--Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.0120.001895%Not Available
Musculoskeletal stiffness15.03.05.0270.000861%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Depressive symptom19.15.02.003--Not Available
Dysphemia19.19.03.005; 17.02.08.0100.002325%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.041943%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.002928%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.005856%Not Available
Angiopathy24.03.02.007--Not Available
Adverse event08.06.01.0100.013005%Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Eye movement disorder17.02.05.025; 06.05.02.0080.002325%Not Available
Impulse-control disorder19.18.01.0020.002928%Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Abnormal behaviour19.01.01.0010.006115%Not Available
Blood disorder01.05.01.004--Not Available
Psychotic disorder19.03.01.0020.006545%
Grimacing17.02.05.0290.001895%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Oral mucosal exfoliation07.05.05.0110.000861%Not Available
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