85/100 · Critical
Manufactured by Accord Healthcare Inc.
Escitalopram Adverse Events: High Seriousness and Diverse Reactions
110,110 FDA adverse event reports analyzed
Last updated: 2026-05-12
ESCITSLOPRAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. Based on analysis of 110,110 FDA adverse event reports, ESCITSLOPRAM has a safety score of 85 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 ESCITSLOPRAM include DRUG INEFFECTIVE, FATIGUE, NAUSEA, OFF LABEL USE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESCITSLOPRAM.
Escitslopram has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 110,110 adverse event reports for this medication, which is primarily manufactured by Accord Healthcare Inc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 79.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Escitalopram reports include a high percentage of serious adverse events, particularly related to mental health and neurological issues.
A wide variety of reactions are reported, indicating potential for diverse side effects. The drug is frequently reported to cause suicidal ideation and attempts, highlighting significant mental health risks.
Patients taking Escitslopram should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Escitalopram can interact with other drugs, potentially leading to serotonin syndrome or other adverse effects. Patients should avoid certain medications and inform healthcare providers of all current medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Escitslopram received a safety concern score of 85/100 (high concern). This is based on a 79.7% serious event ratio across 55,175 classified reports. The score accounts for 110,110 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 32,039, Male: 17,277, Unknown: 121. The most frequently reported age groups are age 65 (854 reports), age 63 (828 reports), age 56 (796 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 55,175 classified reports for ESCITSLOPRAM:
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.
Escitalopram can interact with other drugs, potentially leading to serotonin syndrome or other adverse effects. Patients should avoid certain medications and inform healthcare providers of all current medications.
If you are taking Escitslopram, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, nausea, off label use, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about any existing mental health conditions before starting Escitalopram. Report any suicidal thoughts or behaviors immediately to your healthcare provider. 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.
Escitalopram is under close FDA monitoring due to its high rate of serious adverse events, particularly related to mental health. Healthcare providers should be vigilant and monitor patients closely.
The FDA has received approximately 110,110 adverse event reports associated with Escitslopram. 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 Escitslopram include Drug Ineffective, Fatigue, Nausea, Off Label Use, Diarrhoea. By volume, the top reported reactions are: Drug Ineffective (3,669 reports), Fatigue (3,359 reports), Nausea (3,176 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Escitslopram.
Out of 55,175 classified reports, 43,956 (79.7%) were classified as serious and 11,219 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 Escitslopram break down by patient sex as follows: Female: 32,039, Male: 17,277, Unknown: 121. 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 Escitslopram adverse events are: age 65: 854 reports, age 63: 828 reports, age 56: 796 reports, age 62: 782 reports, age 67: 743 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 Escitslopram adverse event reports is Accord Healthcare 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 Escitslopram include: Headache, Drug Interaction, Fall, Anxiety, 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 Escitslopram 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.
Escitslopram has a safety concern score of 85 out of 100 (high 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. Escitalopram reports include a high percentage of serious adverse events, particularly related to mental health and neurological issues.
Key safety signals identified in Escitslopram's adverse event data include: Serious adverse events (43,956) constitute 79.7% of all reports, indicating high concern.. Mental health issues such as depression, anxiety, and suicidal ideation are frequently reported.. Neurological symptoms like dizziness, confusion, and syncope are also common.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Escitalopram can interact with other drugs, potentially leading to serotonin syndrome or other adverse effects. Patients should avoid certain medications and inform healthcare providers of all current medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Escitslopram.
Inform your healthcare provider about any existing mental health conditions before starting Escitalopram. Report any suicidal thoughts or behaviors immediately to your healthcare provider.
Escitslopram has 110,110 adverse event reports on file with the FDA. A wide variety of reactions are reported, indicating potential for diverse side effects. The volume of reports for Escitslopram reflects both the drug's usage level and the vigilance of the reporting community.
Escitalopram is under close FDA monitoring due to its high rate of serious adverse events, particularly related to mental health. Healthcare providers should be vigilant and monitor patients closely. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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