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 flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Adverse event08.06.01.0100.003257%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000799%Not Available
Genital haemorrhage24.07.03.007; 21.10.05.0020.001184%Not Available
Limb discomfort15.03.04.0140.000799%Not Available
Malnutrition14.03.02.004--Not Available
Mental disorder19.07.01.002--Not Available
Abnormal behaviour19.01.01.001--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.0010.003879%
Inner ear disorder04.04.02.002--Not Available
Psychotic disorder19.03.01.0020.001096%
Haemorrhagic diathesis24.07.01.020; 01.01.03.0030.000799%Not Available
Suicidal behaviour19.12.01.0060.000592%Not Available
Hypersexuality19.08.03.0050.001007%Not Available
Activation syndrome19.06.02.008; 17.02.05.0410.000592%Not Available
Low birth weight baby18.04.02.0030.000296%Not Available
Reversible cerebral vasoconstriction syndrome24.04.06.026; 18.06.01.004; 17.08.02.0140.000296%Not Available
Meige's syndrome17.01.02.0220.000296%Not Available
Tachyphrenia17.03.03.007; 19.10.03.0100.001510%Not Available
Internal haemorrhage24.07.01.0720.000444%Not Available
Behaviour disorder19.01.01.0050.000651%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.038--Not Available
Electric shock sensation17.02.07.024; 08.06.02.023--Not Available
Illness08.01.03.0910.001806%Not Available
Pharyngeal swelling22.04.05.0280.000651%Not Available
Psychotic symptom19.03.01.0120.000888%Not Available
Swelling of eyelid10.01.05.026; 23.04.01.026; 06.04.04.0180.001007%Not Available
Therapeutic product effect decreased08.06.01.0500.003168%Not Available
Therapeutic product ineffective08.06.01.057--Not Available
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