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)
Spontaneous penile erection21.03.01.0100.000204%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.000814%Not Available
Morbid thoughts19.10.03.0040.000185%Not Available
Self-injurious ideation19.12.01.0070.000139%Not Available
Nasal discomfort22.12.03.0120.003192%Not Available
Drug tolerance08.06.01.0030.000315%Not Available
Depressive symptom19.15.02.0030.001314%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.001018%Not Available
Bipolar disorder19.16.01.0030.000139%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.001147%
Major depression19.15.01.0030.000435%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.000361%Not Available
Adverse event08.06.01.0100.002729%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000093%Not Available
Eye movement disorder17.02.05.025; 06.05.02.0080.000093%Not Available
Limb discomfort15.03.04.0140.000361%Not Available
Mental disorder19.07.01.0020.000796%Not Available
Adverse drug reaction08.06.01.0090.001712%Not Available
Psychotic disorder19.03.01.0020.001018%
Poor quality sleep19.02.05.005; 17.15.04.0020.000204%Not Available
Metamorphopsia17.17.01.020; 06.02.06.0140.000315%Not Available
Skin haemorrhage24.07.01.103; 23.06.07.0010.000315%Not Available
Suicidal behaviour19.12.01.0060.000093%Not Available
Substance abuse19.07.06.0180.000093%Not Available
Adverse reaction08.06.01.0180.000204%Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.0080.000093%Not Available
Language disorder17.02.08.015; 19.19.01.0060.000204%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.000204%
Flashback19.10.05.0050.000296%Not Available
Post-traumatic stress disorder19.06.06.0020.000231%Not Available
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