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 Not Available
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
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Agitation17.02.05.012; 19.06.02.0010.001059%
Akathisia19.06.02.006; 17.01.02.0020.000424%
Anxiety19.06.02.0020.006353%
Blood pressure decreased13.14.03.0020.000424%Not Available
Blood pressure increased13.14.03.0050.004023%Not Available
Body temperature increased13.15.01.0010.000424%Not Available
Completed suicide19.12.01.001; 08.04.01.0100.000110%Not Available
Crying17.02.05.013; 12.02.11.001; 08.01.03.005; 19.04.02.0020.000424%Not Available
Depressed mood19.15.02.0010.000635%Not Available
Depression19.15.01.0010.005294%
Diplopia17.17.01.005; 06.02.06.0020.000424%Not Available
Dissociation19.14.01.0020.011012%Not Available
Dissociative disorder19.14.01.0030.000635%Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.003812%
Dysgeusia17.02.07.003; 07.14.03.0010.002965%
Dyspnoea02.01.03.002; 22.02.01.004--
Emotional disorder19.04.02.0050.000635%Not Available
Euphoric mood19.04.02.0060.001059%
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.004023%Not Available
Feeling drunk08.01.09.0150.000847%Not Available
Hallucination19.10.02.0020.000424%
Headache17.14.01.0010.002329%
Hyperacusis17.04.03.003; 04.02.02.0010.000424%Not Available
Hypersensitivity10.01.03.0030.000424%
Hypertension24.08.02.0010.001906%
Hypoaesthesia17.02.06.0230.001694%Not Available
Hypokinesia17.01.02.0090.000424%Not Available
Insomnia19.02.01.002; 17.15.03.0020.001059%
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.000424%
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