Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Esketamine
Drug ID BADD_D02488
Description Major depressive disorder (MDD) is a significant cause of disability worldwide and the most common illness preceding suicide [L5596], [A175462]. On March 5, 2019, the nasal spray drug, _esketamine_, also known as _Spravato_ (by Janssen Pharmaceuticals), was approved by the FDA for treatment-resistant major depression. Esketamine is the s-enantiomer of [Ketamine]. Ketamine is a mixture of two enantiomers (mirror image molecules). This is the first time that the FDA has approved esketamine for any use. The FDA approved ketamine (Ketalar) in 1970 [L5593]. Esketamine may prove to be a promising treatment for patients diagnosed with major depressive disorder who have not experienced an improvement in symptoms despite treatment with various medications and therapies. The intranasal route of administration for this drug allows for easy administration and a fast onset of action, which sets it apart from many other antidepressant agents that may take several weeks to take effect.
Indications and Usage This drug is indicated in conjunction with an oral antidepressant for the treatment of treatment-resistant depression (TRD) in adults [FDA label]. Note: Esketamine is not approved as an anesthetic agent. The safety and effectiveness of esketamine as an anesthetic agent have not been established to this date [FDA label].
Marketing Status approved; investigational
ATC Code N01AX14; N06AX27
DrugBank ID DB11823
KEGG ID D07283
MeSH ID C000629870
PubChem ID 182137
TTD Drug ID D0TP5H
NDC Product Code 65267-117
UNII 50LFG02TXD
Synonyms Esketamine | Kataved | S-Ketamine | (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone | L-Ketamine | (-)-Ketamine | Spravato
Chemical Information
Molecular Formula C13H16ClNO
CAS Registry Number 33643-46-8
SMILES CNC1(CCCCC1=O)C2=CC=CC=C2Cl
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)
Agitation17.02.05.012; 19.06.02.0010.001693%
Akathisia19.06.02.006; 17.01.02.0020.000472%
Alcohol abuse19.07.06.0010.000093%Not Available
Alcoholism19.07.06.0060.000185%Not Available
Amnesia19.20.01.001; 17.03.02.0010.000860%
Anger19.04.02.0010.000879%Not Available
Anorgasmia19.08.01.0010.000315%
Anosmia22.04.03.006; 17.04.04.0010.000472%
Anxiety19.06.02.0020.013138%
Aphasia19.21.01.001; 17.02.03.0010.000407%
Bladder pain20.02.02.0010.000093%Not Available
Burning sensation17.02.06.001; 08.01.09.0290.000675%Not Available
Catatonia19.11.01.0010.000342%Not Available
Completed suicide19.12.01.001; 08.04.01.0100.001712%Not Available
Conversion disorder19.24.01.0010.000093%Not Available
Crying12.02.11.001; 08.01.03.005; 19.04.02.002; 17.02.05.0130.001693%Not Available
Cyanosis23.06.04.005; 02.11.04.004; 24.03.01.007; 22.02.02.0070.000204%
Delusion19.10.01.0010.000204%
Dementia17.03.01.001; 19.20.02.0010.000139%Not Available
Dependence19.07.06.0080.000139%Not Available
Depressed level of consciousness17.02.04.0020.000370%
Depressed mood19.15.02.0010.000796%Not Available
Depression19.15.01.0010.013730%
Depression suicidal19.15.01.0040.000093%Not Available
Derealisation19.10.05.0040.000518%Not Available
Diplopia17.17.01.005; 06.02.06.0020.000139%Not Available
Discomfort08.01.08.0030.000833%Not Available
Disorientation19.13.01.002; 17.02.05.0150.000611%Not Available
Dissociation19.14.01.0020.033677%Not Available
Dissociative disorder19.14.01.0030.001517%Not Available
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