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)
Panic disorder19.06.04.0020.000204%Not Available
Paralysis17.01.04.0040.000185%Not Available
Paranoia19.05.01.0050.000546%Not Available
Parosmia22.04.03.007; 17.04.04.0020.000315%Not Available
Pollakiuria20.02.02.0070.001258%
Psychomotor hyperactivity19.11.02.003; 17.01.02.0110.000361%Not Available
Retching07.01.07.0020.000315%Not Available
Rhinorrhoea22.12.03.0210.000564%
Screaming19.04.02.020; 08.01.03.0990.000093%Not Available
Sedation17.02.04.0050.016135%Not Available
Sensory disturbance17.02.07.0060.000527%Not Available
Sinus congestion22.04.06.0010.000315%Not Available
Sneezing22.12.03.0240.000361%
Somnolence19.02.05.003; 17.02.04.0060.002665%
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.000296%Not Available
Suicidal ideation19.12.01.0030.007716%
Suicide attempt19.12.01.0040.001989%
Tachyphylaxis10.02.01.050; 08.06.01.0280.000315%Not Available
Therapeutic response decreased08.06.01.0160.001194%Not Available
Therapeutic response unexpected08.06.01.0010.000518%Not Available
Thinking abnormal19.10.03.001; 17.02.05.0230.000093%Not Available
Throat irritation22.12.03.029; 07.05.05.0370.000990%Not Available
Transient ischaemic attack17.08.04.001; 24.04.06.0050.000389%
Unresponsive to stimuli17.02.05.0310.000435%Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.000500%
Vertigo17.02.12.002; 04.04.01.0030.001332%
Vision blurred17.17.01.010; 06.02.06.0070.001601%
Vomiting07.01.07.0030.018744%
Vomiting projectile07.01.07.0120.000093%Not Available
Withdrawal syndrome19.07.06.023; 08.06.02.0120.000814%Not Available
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