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)
Pancreatitis acute07.18.01.002--Not Available
Panic attack19.06.04.0010.000444%Not Available
Panic disorder19.06.04.0020.001007%Not Available
Paraesthesia23.03.03.094; 17.02.06.0050.008349%
Parosmia17.04.04.002; 22.04.03.0070.002013%Not Available
Peripheral sensory neuropathy17.09.03.0050.000651%
Personality change19.05.01.006; 17.02.05.0190.000651%
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.0020.001007%Not Available
Photophobia17.17.02.006; 06.01.01.0040.000651%
Pregnancy18.08.02.0040.005507%Not Available
Pruritus23.03.12.0010.043317%
Rash23.03.13.0010.021584%Not Available
Rash macular23.03.13.0030.001007%Not Available
Rash papular23.03.13.0170.001155%Not Available
Rash pruritic23.03.13.0300.004530%Not Available
Restlessness19.11.02.002; 17.02.05.0210.001303%
Retching07.01.07.0020.000651%Not Available
Rhinorrhoea22.12.03.021--
Salivary hypersecretion07.06.01.0090.001007%Not Available
Sedation17.02.04.0050.003168%Not Available
Serotonin syndrome17.05.02.004; 15.05.04.016; 12.03.01.0410.002369%Not Available
Sexual dysfunction19.08.05.002; 21.03.02.0030.012672%Not Available
Skin disorder23.03.03.007--Not Available
Sleep disorder19.02.04.0010.002754%Not Available
Social avoidant behaviour19.05.01.007--Not Available
Suicidal ideation19.12.01.0030.015100%
Suicide attempt19.12.01.0040.004293%
Tardive dyskinesia17.01.02.0120.001096%Not Available
Tension19.06.02.005--Not Available
Tension headache19.24.01.009; 17.14.01.0040.000651%Not Available
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