Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Asenapine maleate
Drug ID BADD_D00173
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 D02995
MeSH ID C522667
PubChem ID 163091
TTD Drug ID D00JRA
NDC Product Code 0456-2407; 50379-0004; 50379-0009; 62938-0045; 51991-359; 51991-360; 0456-2410; 0456-2405; 69539-060; 60870-0468; 51991-358; 69539-059; 62938-0016; 62938-0017; 62938-0040; 69539-245; 17337-0309; 62938-0041; 0456-2404; 51991-361; 59762-2012; 69539-057; 53296-0104; 65015-817; 59762-1091; 59762-2888; 0456-2412; 0456-2402; 69539-058; 55111-937; 51991-928
UNII CU9463U2E2
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)
Abdominal discomfort07.01.06.001---
Akathisia17.01.02.002; 19.06.02.006--
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Bipolar I disorder19.16.01.002---
Blister12.01.06.002; 23.03.01.001---
Constipation07.02.02.001--
Depression19.15.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dry mouth07.06.01.002--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Extrapyramidal disorder17.01.02.007--
Fatigue08.01.01.002--
Headache17.14.01.001--
Hypertension24.08.02.001--
Increased appetite08.01.09.027; 14.03.01.003---
Insomnia17.15.03.002; 19.02.01.002--
Irritability08.01.03.011; 19.04.02.013--
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Pain in extremity15.03.04.010--
Salivary hypersecretion07.06.01.009---
Somnolence17.02.04.006; 19.02.05.003--
Suicidal ideation19.12.01.003--
Toothache07.09.06.001--
Ulcer08.03.06.001---
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Hypoaesthesia oral07.05.05.003; 17.02.06.021---
Inflammation08.01.05.007; 10.02.01.089---
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