85/100 · Critical
Manufactured by Legacy Pharma USA, Inc.
Serious Adverse Events Dominate Paroxetine Safety Profile
67,572 FDA adverse event reports analyzed
Last updated: 2026-05-12
PAROXETINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Legacy Pharma USA, Inc.. Based on analysis of 67,572 FDA adverse event reports, PAROXETINE 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 PAROXETINE include DRUG INEFFECTIVE, DRUG INTERACTION, FATIGUE, NAUSEA, TOXICITY TO VARIOUS AGENTS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PAROXETINE.
Paroxetine 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 67,572 adverse event reports for this medication, which is primarily manufactured by Legacy Pharma Usa, Inc..
The most commonly reported adverse events include Drug Ineffective, Drug Interaction, Fatigue. Of classified reports, 81.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events such as suicidal ideation, depression, and death are common.
A wide range of reactions including drug interactions and toxicity are reported. Falls and confusion are frequent, indicating potential cognitive and physical risks.
Patients taking Paroxetine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Paroxetine can interact with other drugs, and toxicity to various agents is a key concern. Patients should inform their healthcare providers of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Paroxetine received a safety concern score of 85/100 (high concern). This is based on a 81.9% serious event ratio across 32,662 classified reports. The score accounts for 67,572 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: 19,168, Male: 10,466, Unknown: 83. The most frequently reported age groups are age 53 (516 reports), age 54 (513 reports), age 60 (512 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 32,662 classified reports for PAROXETINE:
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.
Paroxetine can interact with other drugs, and toxicity to various agents is a key concern. Patients should inform their healthcare providers of all medications they are taking.
If you are taking Paroxetine, here are important things to know. The most commonly reported side effects include drug ineffective, drug interaction, fatigue, nausea, toxicity to various agents. 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 or medications you are taking. Be aware of potential serious side effects and report them to your doctor promptly. 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 closely monitors Paroxetine's safety, and any new or worsening symptoms should be reported to healthcare providers immediately.
The FDA has received approximately 67,572 adverse event reports associated with Paroxetine. 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 Paroxetine include Drug Ineffective, Drug Interaction, Fatigue, Nausea, Toxicity To Various Agents. By volume, the top reported reactions are: Drug Ineffective (2,032 reports), Drug Interaction (1,825 reports), Fatigue (1,821 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Paroxetine.
Out of 32,662 classified reports, 26,748 (81.9%) were classified as serious and 5,914 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 Paroxetine break down by patient sex as follows: Female: 19,168, Male: 10,466, Unknown: 83. 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 Paroxetine adverse events are: age 53: 516 reports, age 54: 513 reports, age 60: 512 reports, age 65: 509 reports, age 68: 509 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 Paroxetine adverse event reports is Legacy Pharma Usa, 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 Paroxetine include: Anxiety, Diarrhoea, Headache, Dizziness, Off Label Use. 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 Paroxetine 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.
Paroxetine 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. Serious adverse events such as suicidal ideation, depression, and death are common.
Key safety signals identified in Paroxetine's adverse event data include: Suicidal ideation and completed suicide are significant safety signals.. Drug interactions and toxicity are frequently reported, highlighting the need for caution.. Serious adverse events like death and falls are prevalent, indicating potential risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Paroxetine can interact with other drugs, and toxicity to various agents is a key concern. Patients should inform their healthcare providers of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Paroxetine.
Inform your healthcare provider about any existing medical conditions or medications you are taking. Be aware of potential serious side effects and report them to your doctor promptly.
Paroxetine has 67,572 adverse event reports on file with the FDA. A wide range of reactions including drug interactions and toxicity are reported. The volume of reports for Paroxetine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Paroxetine's safety, and any new or worsening symptoms should be reported to healthcare providers immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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