82/100 · Critical
Manufactured by Amneal Pharmaceuticals LLC
Escitalopram Oxalate Adverse Events: High Seriousness and Diverse Reactions
141,159 FDA adverse event reports analyzed
Last updated: 2026-05-12
ESCITALOPRAM OXALATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. Based on analysis of 141,159 FDA adverse event reports, ESCITALOPRAM OXALATE has a safety score of 82 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 ESCITALOPRAM OXALATE include DRUG INEFFECTIVE, FATIGUE, NAUSEA, OFF LABEL USE, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESCITALOPRAM OXALATE.
Escitalopram Oxalate has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 141,159 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Llc.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 78.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events such as death, suicide, and cardiovascular issues are common.
A wide range of reactions, including psychiatric and gastrointestinal issues, are reported. The majority of adverse events are serious, indicating a high risk profile.
Patients taking Escitalopram Oxalate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Escitalopram Oxalate can interact with other drugs, potentially leading to adverse effects. Warnings include interactions with anticoagulants, MAOIs, and other psychotropic medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Escitalopram Oxalate received a safety concern score of 82/100 (high concern). This is based on a 78.1% serious event ratio across 68,928 classified reports. The score accounts for 141,159 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: 40,507, Male: 21,224, Unknown: 154. The most frequently reported age groups are age 65 (1,063 reports), age 72 (999 reports), age 63 (974 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 68,928 classified reports for ESCITALOPRAM OXALATE:
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 Oxalate can interact with other drugs, potentially leading to adverse effects. Warnings include interactions with anticoagulants, MAOIs, and other psychotropic medications.
If you are taking Escitalopram Oxalate, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, nausea, off label use, headache. 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 all other medications you are taking to avoid potential drug interactions. Be vigilant for signs of suicidal thoughts or behaviors, especially in the first few weeks of treatment. 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 Oxalate is subject to strict FDA oversight due to its high risk of serious adverse events. Patients should be closely monitored, especially for signs of suicidal ideation and cardiovascular issues.
The FDA has received approximately 141,159 adverse event reports associated with Escitalopram Oxalate. 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 Escitalopram Oxalate include Drug Ineffective, Fatigue, Nausea, Off Label Use, Headache. By volume, the top reported reactions are: Drug Ineffective (4,550 reports), Fatigue (4,371 reports), Nausea (4,136 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Escitalopram Oxalate.
Out of 68,928 classified reports, 53,814 (78.1%) were classified as serious and 15,114 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 Escitalopram Oxalate break down by patient sex as follows: Female: 40,507, Male: 21,224, Unknown: 154. 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 Escitalopram Oxalate adverse events are: age 65: 1,063 reports, age 72: 999 reports, age 63: 974 reports, age 56: 965 reports, age 62: 960 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 Escitalopram Oxalate adverse event reports is Amneal Pharmaceuticals Llc. 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 Escitalopram Oxalate include: Diarrhoea, Drug Interaction, Dizziness, Fall, Anxiety. 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 Escitalopram Oxalate 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.
Escitalopram Oxalate has a safety concern score of 82 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. Serious adverse events such as death, suicide, and cardiovascular issues are common.
Key safety signals identified in Escitalopram Oxalate's adverse event data include: Death and completed suicides are among the most serious reported events.. Cardiovascular issues like QT prolongation and arrhythmias are frequently reported.. Psychiatric symptoms such as anxiety, depression, and suicidal ideation are prevalent.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Escitalopram Oxalate can interact with other drugs, potentially leading to adverse effects. Warnings include interactions with anticoagulants, MAOIs, and other psychotropic medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Escitalopram Oxalate.
Inform your healthcare provider about all other medications you are taking to avoid potential drug interactions. Be vigilant for signs of suicidal thoughts or behaviors, especially in the first few weeks of treatment.
Escitalopram Oxalate has 141,159 adverse event reports on file with the FDA. A wide range of reactions, including psychiatric and gastrointestinal issues, are reported. The volume of reports for Escitalopram Oxalate reflects both the drug's usage level and the vigilance of the reporting community.
Escitalopram Oxalate is subject to strict FDA oversight due to its high risk of serious adverse events. Patients should be closely monitored, especially for signs of suicidal ideation and cardiovascular issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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