Background: Vortioxetine is approved for the treatment of Major Depressive Disorder
(MDD). However, the safety of this drug in a large group of populations is still unclear. Thus, we
have tried to analyze the risk profile of vortioxetine.
Material and Methods: The data related to the risk profile of vortioxetine has been extracted from
Pub-Med from January 2014 to May 2019. The adverse drug reactions (ADRs) have been categorized
into listed and unlisted categories as per the Summary of product characteristics (SmPC) of
the innovator. Further, unlisted ADRs have been analyzed as per Naranjo Scale.
Results: Galactorrhea, hyperprolactinemia, glycolimia, exacerbation of anxiety, weight gain, edema,
excessive itching, petechiae, and ecchymoses have been observed with the use of vortioxetine
and falls under the unlisted category. Further, the causality assessment results have shown a probable
relation between vortioxetine and galactorrhea, hyperprolactinemia, edema, excessive itching,
ecchymoses, and petechiae. Weight gain, glycolimia and exacerbation of anxiety have a possible relationship
with vortioxetine. The common ADRs observed with the use of vortioxetine are nausea,
diarrhea, constipation, vomiting, pruritus, including pruritus generalized, abnormal dreams, and
Conclusion: In conclusion, more data is required to establish a strong relationship between vortioxetine
and reported unlisted ADRs.