82/100 · Critical
Manufactured by Amneal Pharmaceuticals NY LLC
Sertraline Adverse Events: High Seriousness and Diverse Reactions
201,088 FDA adverse event reports analyzed
Last updated: 2026-05-12
SERTRALINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. Based on analysis of 201,088 FDA adverse event reports, SERTRALINE 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 SERTRALINE include DRUG INEFFECTIVE, NAUSEA, FATIGUE, DIARRHOEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SERTRALINE.
Sertraline 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 201,088 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Ny Llc.
The most commonly reported adverse events include Drug Ineffective, Nausea, Fatigue. Of classified reports, 78.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Sertraline reports show a high percentage of serious adverse events, particularly related to mental health and suicidal ideation.
The drug is associated with a wide range of reactions, including neurological, gastrointestinal, and cardiovascular issues. Sertraline is frequently reported to cause weight changes and sexual dysfunction.
Patients taking Sertraline should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sertraline can interact with other drugs, potentially leading to serotonin syndrome. It is important to inform healthcare providers of all medications being taken. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sertraline received a safety concern score of 82/100 (high concern). This is based on a 78.9% serious event ratio across 112,179 classified reports. The score accounts for 201,088 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: 65,308, Male: 35,758, Unknown: 284. The most frequently reported age groups are age 54 (1,657 reports), age 58 (1,489 reports), age 64 (1,443 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 112,179 classified reports for SERTRALINE:
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.
Sertraline can interact with other drugs, potentially leading to serotonin syndrome. It is important to inform healthcare providers of all medications being taken.
If you are taking Sertraline, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, fatigue, diarrhoea, 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 any existing medical conditions, especially psychiatric disorders, before starting sertraline. Monitor for signs of suicidal thoughts or behaviors, and report any changes to your healthcare provider immediately. 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.
Sertraline is subject to strict FDA oversight due to its potential for serious adverse events, particularly in psychiatric conditions and suicidal behavior.
The FDA has received approximately 201,088 adverse event reports associated with Sertraline. 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 Sertraline include Drug Ineffective, Nausea, Fatigue, Diarrhoea, Headache. By volume, the top reported reactions are: Drug Ineffective (6,804 reports), Nausea (6,467 reports), Fatigue (5,890 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Sertraline.
Out of 112,179 classified reports, 88,563 (78.9%) were classified as serious and 23,616 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 Sertraline break down by patient sex as follows: Female: 65,308, Male: 35,758, Unknown: 284. 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 Sertraline adverse events are: age 54: 1,657 reports, age 58: 1,489 reports, age 64: 1,443 reports, age 67: 1,426 reports, age 62: 1,392 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 Sertraline adverse event reports is Amneal Pharmaceuticals Ny 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 Sertraline include: Dizziness, Off Label Use, Anxiety, Drug Interaction, Vomiting. 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 Sertraline 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.
Sertraline 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. Sertraline reports show a high percentage of serious adverse events, particularly related to mental health and suicidal ideation.
Key safety signals identified in Sertraline's adverse event data include: Serious adverse events (88,563 out of 112,179, 78.9%). High incidence of suicidal ideation and completed suicides. Multiple neurological reactions including confusion, tremors, and seizures. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sertraline can interact with other drugs, potentially leading to serotonin syndrome. It is important to inform healthcare providers of all medications being taken. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sertraline.
Inform your healthcare provider about any existing medical conditions, especially psychiatric disorders, before starting sertraline. Monitor for signs of suicidal thoughts or behaviors, and report any changes to your healthcare provider immediately.
Sertraline has 201,088 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including neurological, gastrointestinal, and cardiovascular issues. The volume of reports for Sertraline reflects both the drug's usage level and the vigilance of the reporting community.
Sertraline is subject to strict FDA oversight due to its potential for serious adverse events, particularly in psychiatric conditions and suicidal behavior. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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