72/100 · Elevated
Manufactured by Takeda Pharmaceuticals America, Inc.
Vortioxetine Adverse Events: Nausea, Fatigue, and Suicidal Ideation Top the List
37,390 FDA adverse event reports analyzed
Last updated: 2026-05-12
VORTIOXETINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. Based on analysis of 37,390 FDA adverse event reports, VORTIOXETINE has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for VORTIOXETINE include NAUSEA, FATIGUE, DRUG INEFFECTIVE, HEADACHE, ANXIETY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VORTIOXETINE.
Vortioxetine has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 37,390 adverse event reports for this medication, which is primarily manufactured by Takeda Pharmaceuticals America, Inc..
The most commonly reported adverse events include Nausea, Fatigue, Drug Ineffective. Of classified reports, 47.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nausea and fatigue are the most common adverse events reported.
Suicidal ideation is a significant safety concern, with multiple reports. Serious adverse events, including death and stroke, are noted but less frequent.
Patients taking Vortioxetine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Vortioxetine can cause drug interactions, and patients should be warned about potential misuse and overdose. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Vortioxetine received a safety concern score of 72/100 (elevated concern). This is based on a 47.4% serious event ratio across 16,232 classified reports. The score accounts for 37,390 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 9,914, Male: 4,284, Unknown: 33. The most frequently reported age groups are age 65 (244 reports), age 5 (217 reports), age 56 (184 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 16,232 classified reports for VORTIOXETINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Vortioxetine can cause drug interactions, and patients should be warned about potential misuse and overdose.
If you are taking Vortioxetine, here are important things to know. The most commonly reported side effects include nausea, fatigue, drug ineffective, headache, anxiety. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any suicidal thoughts or behaviors to their healthcare provider immediately. Follow prescribed dosing and usage instructions to avoid drug interactions and misuse. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor vortioxetine for safety, particularly regarding suicidal ideation and serious adverse events.
The FDA has received approximately 37,390 adverse event reports associated with Vortioxetine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Vortioxetine include Nausea, Fatigue, Drug Ineffective, Headache, Anxiety. By volume, the top reported reactions are: Nausea (2,185 reports), Fatigue (1,179 reports), Drug Ineffective (1,063 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Vortioxetine.
Out of 16,232 classified reports, 7,691 (47.4%) were classified as serious and 8,541 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Vortioxetine break down by patient sex as follows: Female: 9,914, Male: 4,284, Unknown: 33. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Vortioxetine adverse events are: age 65: 244 reports, age 5: 217 reports, age 56: 184 reports, age 50: 181 reports, age 60: 177 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Vortioxetine adverse event reports is Takeda Pharmaceuticals America, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Vortioxetine include: Vomiting, Insomnia, Suicidal Ideation, Off Label Use, Dizziness. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Vortioxetine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Vortioxetine has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Nausea and fatigue are the most common adverse events reported.
Key safety signals identified in Vortioxetine's adverse event data include: Suicidal ideation and attempts are key safety signals.. Serious adverse events like sepsis and haemorrhagic stroke are reported.. Drug interactions and misuse are also important signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Vortioxetine can cause drug interactions, and patients should be warned about potential misuse and overdose. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Vortioxetine.
Patients should report any suicidal thoughts or behaviors to their healthcare provider immediately. Follow prescribed dosing and usage instructions to avoid drug interactions and misuse.
Vortioxetine has 37,390 adverse event reports on file with the FDA. Suicidal ideation is a significant safety concern, with multiple reports. The volume of reports for Vortioxetine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor vortioxetine for safety, particularly regarding suicidal ideation and serious adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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