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)
Leukopenia01.02.02.001--Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.001895%Not Available
Loss of consciousness17.02.04.0040.005770%Not Available
Malaise08.01.01.003--
Mania19.16.02.0020.006718%
Memory impairment19.20.01.003; 17.03.02.0030.003187%
Mental impairment17.03.03.002; 19.21.02.0030.001895%Not Available
Mouth haemorrhage24.07.02.014; 07.05.02.0010.001895%
Mouth ulceration07.05.06.0040.009215%Not Available
Movement disorder17.01.02.0100.004220%Not Available
Muscle rigidity17.05.02.005; 15.05.04.001--Not Available
Muscle spasms15.05.03.0040.013608%
Muscle twitching15.05.03.0050.004823%Not Available
Musculoskeletal pain15.03.04.0070.002325%
Myocardial infarction24.04.04.009; 02.02.02.0070.001722%
Nausea07.01.07.001--
Nervous system disorder17.02.10.0010.001722%Not Available
Nervousness19.06.02.0030.002756%Not Available
Neuroleptic malignant syndrome17.05.02.003; 15.05.04.015; 12.03.01.003; 08.05.01.0050.000861%Not Available
Neutropenia01.02.03.004--Not Available
Nightmare19.02.03.0030.004392%Not Available
Ocular hyperaemia06.04.05.0040.000861%Not Available
Oedema14.05.06.010; 08.01.07.0060.008612%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.010077%
Oral discomfort07.05.05.0010.007148%Not Available
Oral mucosal blistering07.05.05.0170.004392%Not Available
Oral mucosal eruption07.05.05.0180.002928%Not Available
Oral pain07.05.05.0340.003359%
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Osteoarthritis15.01.04.001--Not Available
The 4th Page    First    Pre   4 5 6 7 8    Next   Last    Total 8 Pages