Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Vortioxetine
Drug ID BADD_D02371
Description Vortioxetine is an atypical antipsychotic and antidepressant indicated for the treatment of major depressive disorder (MDD). It is classified as a serotonin modulator and simulator (SMS) as it has a multimodal mechanism of action towards the serotonin neurotransmitter system whereby it simultaneously modulates one or more serotonin receptors and inhibits the reuptake of serotonin. More specifically, vortioxetine acts via the following biological mechanisms: as a serotonin reuptake inhibitor (SRI) through inhibition of the serotonin transporter, as a partial agonist of the 5-HT1B receptor, an agonist of 5-HT1A, and an antagonist of the 5-HT3, 5-HT1D, and 5-HT7 receptors. SMSs were developed because there are many different subtypes of serotonin receptors, however, not all of these receptors appear to be involved in the antidepressant effects of SRIs. Some serotonin receptors seem to play a relatively neutral or insignificant role in the regulation of mood, but others, such as 5-HT1A autoreceptors and 5-HT7 receptors, appear to play an oppositional role in the efficacy of SRIs in treating depression.
Indications and Usage Vortioxetine is indicated for the treatment of major depressive disorder (MDD).
Marketing Status approved; investigational
ATC Code N06AX26
DrugBank ID DB09068
KEGG ID D10184
MeSH ID D000078784
PubChem ID 9966051
TTD Drug ID D03WEX
NDC Product Code 47234-4105; 47234-4120; 55154-0256; 64764-750; 55154-0257; 64764-730; 70518-2642; 47234-4110; 64764-720
UNII 3O2K1S3WQV
Synonyms Vortioxetine | 1-(2-(2,4-Dimethylphenylsulfanyl)phenyl)piperazine | Lu AA21004 | LuAA21004 | Lu-AA21004 | Brintellix | Vortioxetine Hydrobromide
Chemical Information
Molecular Formula C18H22N2S
CAS Registry Number 508233-74-7
SMILES CC1=CC(=C(C=C1)SC2=CC=CC=C2N3CCNCC3)C
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)
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.005--
Adverse event08.06.01.0100.003257%-
Feeding disorder14.03.02.003; 19.09.01.0030.000799%-
Genital haemorrhage21.10.05.002; 24.07.03.0070.001184%-
Limb discomfort15.03.04.0140.000799%-
Malnutrition14.03.02.004---
Mental disorder19.07.01.002---
Abnormal behaviour19.01.01.001---
Decreased appetite08.01.09.028; 14.03.01.005--
Erectile dysfunction19.08.04.001; 21.03.01.0070.003879%
Inner ear disorder04.04.02.002---
Psychotic disorder19.03.01.0020.001096%
Haemorrhagic diathesis01.01.03.003; 24.07.01.0200.000799%-
Suicidal behaviour19.12.01.0060.000592%-
Hypersexuality19.08.03.0050.001007%-
Activation syndrome17.02.05.041; 19.06.02.0080.000592%-
Low birth weight baby18.04.02.0030.000296%-
Reversible cerebral vasoconstriction syndrome17.08.02.014; 18.06.01.004; 24.04.06.0260.000296%-
Meige's syndrome17.01.02.0220.000296%-
Tachyphrenia17.03.03.007; 19.10.03.0100.001510%-
Internal haemorrhage24.07.01.0720.000444%-
Behaviour disorder19.01.01.0050.000651%-
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.002---
Electric shock sensation08.06.02.023; 17.02.07.024---
Illness08.01.03.0910.001806%-
Pharyngeal swelling22.04.05.0280.000651%-
Psychotic symptom19.03.01.0120.000888%-
Swelling of eyelid06.04.04.018; 10.01.05.026; 23.04.01.0260.001007%-
Therapeutic product effect decreased08.06.01.0500.003168%-
Therapeutic product ineffective08.06.01.057---
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