78/100 · Elevated
Manufactured by Viatris Specialty LLC
Sertraline Hydrochloride Adverse Events: High Serious Reaction Rate
227,999 FDA adverse event reports analyzed
Last updated: 2026-05-12
SERTRALINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. Based on analysis of 227,999 FDA adverse event reports, SERTRALINE HYDROCHLORIDE has a safety score of 78 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 HYDROCHLORIDE include DRUG INEFFECTIVE, NAUSEA, FATIGUE, HEADACHE, ANXIETY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SERTRALINE HYDROCHLORIDE.
Sertraline Hydrochloride has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 227,999 adverse event reports for this medication, which is primarily manufactured by Viatris Specialty Llc.
The most commonly reported adverse events include Drug Ineffective, Nausea, Fatigue. Of classified reports, 63.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, such as death and suicidal ideation, are common.
A high percentage of reports involve drug ineffectiveness and nausea. The most frequent reactions include fatigue, headache, and anxiety.
Patients taking Sertraline Hydrochloride 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 adverse effects. Warnings include drug interactions and hyper-sensitivity reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sertraline Hydrochloride received a safety concern score of 78/100 (high concern). This is based on a 63.8% serious event ratio across 114,928 classified reports. The score accounts for 227,999 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: 74,871, Male: 33,102, Unknown: 377. The most frequently reported age groups are age 54 (1,730 reports), age 60 (1,414 reports), age 58 (1,390 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 114,928 classified reports for SERTRALINE HYDROCHLORIDE:
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 adverse effects. Warnings include drug interactions and hyper-sensitivity reactions.
If you are taking Sertraline Hydrochloride, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, fatigue, headache, anxiety. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of suicidal ideation and behavior, especially in the first few months of treatment. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking. 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 monitoring due to its high serious reaction rate. Patients should report any adverse events to their healthcare provider.
The FDA has received approximately 227,999 adverse event reports associated with Sertraline Hydrochloride. 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 Hydrochloride include Drug Ineffective, Nausea, Fatigue, Headache, Anxiety. By volume, the top reported reactions are: Drug Ineffective (8,046 reports), Nausea (7,978 reports), Fatigue (7,502 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 Hydrochloride.
Out of 114,928 classified reports, 73,347 (63.8%) were classified as serious and 41,581 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 Hydrochloride break down by patient sex as follows: Female: 74,871, Male: 33,102, Unknown: 377. 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 Hydrochloride adverse events are: age 54: 1,730 reports, age 60: 1,414 reports, age 58: 1,390 reports, age 65: 1,373 reports, age 62: 1,371 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 Hydrochloride adverse event reports is Viatris Specialty 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 Hydrochloride include: Depression, Diarrhoea, Dizziness, Pain, Dyspnoea. 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 Hydrochloride 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 Hydrochloride has a safety concern score of 78 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 and suicidal ideation, are common.
Key safety signals identified in Sertraline Hydrochloride's adverse event data include: Suicidal ideation and attempts are key safety signals.. Drug ineffectiveness and overdose are significant concerns.. Serious reactions like pneumonia and myocardial infarction are reported.. 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 adverse effects. Warnings include drug interactions and hyper-sensitivity reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sertraline Hydrochloride.
Monitor for signs of suicidal ideation and behavior, especially in the first few months of treatment. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking.
Sertraline Hydrochloride has 227,999 adverse event reports on file with the FDA. A high percentage of reports involve drug ineffectiveness and nausea. The volume of reports for Sertraline Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
Sertraline is subject to strict FDA monitoring due to its high serious reaction rate. Patients should report any adverse events to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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