82/100 · Critical
Manufactured by Apotex Corp
Paroxetine Hydrochloride Adverse Events Show High Seriousness and Diverse Reactions
192,057 FDA adverse event reports analyzed
Last updated: 2026-05-12
PAROXETINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Apotex Corp. Based on analysis of 192,057 FDA adverse event reports, PAROXETINE HYDROCHLORIDE 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 PAROXETINE HYDROCHLORIDE include DRUG WITHDRAWAL SYNDROME, DRUG INEFFECTIVE, NAUSEA, DIZZINESS, ANXIETY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PAROXETINE HYDROCHLORIDE.
Paroxetine Hydrochloride 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 192,057 adverse event reports for this medication, which is primarily manufactured by Apotex Corp.
The most commonly reported adverse events include Drug Withdrawal Syndrome, Drug Ineffective, Nausea. Of classified reports, 68.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events such as suicidal ideation and death are common, with a serious event rate of 68.5%.
A wide range of reactions are reported, including neurological, gastrointestinal, and cardiovascular issues. The drug is frequently associated with drug withdrawal syndrome and drug ineffectiveness. There is a notable presence of psychiatric and neurological adverse events, including anxiety, depression, and agitation. The drug is also linked to various physical symptoms like nausea, dizziness, and fatigue.
Patients taking Paroxetine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Paroxetine Hydrochloride can cause drug withdrawal syndrome and drug ineffectiveness. It is important to monitor patients for signs of suicidal ideation and to manage potential drug interactions, especially with other psychiatric medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Paroxetine Hydrochloride received a safety concern score of 82/100 (high concern). This is based on a 68.5% serious event ratio across 88,783 classified reports. The score accounts for 192,057 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: 54,054, Male: 27,892, Unknown: 222. The most frequently reported age groups are age 53 (1,125 reports), age 57 (1,111 reports), age 54 (1,100 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 88,783 classified reports for PAROXETINE 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.
Paroxetine Hydrochloride can cause drug withdrawal syndrome and drug ineffectiveness. It is important to monitor patients for signs of suicidal ideation and to manage potential drug interactions, especially with other psychiatric medications.
If you are taking Paroxetine Hydrochloride, here are important things to know. The most commonly reported side effects include drug withdrawal syndrome, drug ineffective, nausea, dizziness, anxiety. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should inform their healthcare provider about any existing conditions or medications to avoid potential drug interactions. Regular monitoring and follow-up are crucial to manage the side effects and ensure the drug's effectiveness. 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 continues to monitor Paroxetine Hydrochloride for safety, particularly regarding serious adverse events and drug interactions. Healthcare providers should be vigilant in managing patient care and reporting adverse events.
The FDA has received approximately 192,057 adverse event reports associated with Paroxetine 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 Paroxetine Hydrochloride include Drug Withdrawal Syndrome, Drug Ineffective, Nausea, Dizziness, Anxiety. By volume, the top reported reactions are: Drug Withdrawal Syndrome (6,193 reports), Drug Ineffective (6,065 reports), Nausea (6,000 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 Hydrochloride.
Out of 88,783 classified reports, 60,827 (68.5%) were classified as serious and 27,956 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 Hydrochloride break down by patient sex as follows: Female: 54,054, Male: 27,892, Unknown: 222. 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 Hydrochloride adverse events are: age 53: 1,125 reports, age 57: 1,111 reports, age 54: 1,100 reports, age 60: 1,096 reports, age 59: 1,090 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 Hydrochloride adverse event reports is Apotex Corp. 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 Hydrochloride include: Fatigue, Headache, Depression, Diarrhoea, Insomnia. 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 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.
Paroxetine Hydrochloride 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 suicidal ideation and death are common, with a serious event rate of 68.5%.
Key safety signals identified in Paroxetine Hydrochloride's adverse event data include: Suicidal ideation and death are key safety signals, with a significant number of serious reports.. Drug withdrawal syndrome and ineffectiveness are frequent reported issues.. Neurological and psychiatric adverse events are common, including anxiety, depression, and agitation.. Physical symptoms such as nausea, dizziness, and fatigue are also frequently reported.. Drug interactions and pregnancy exposure are important safety concerns.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Paroxetine Hydrochloride can cause drug withdrawal syndrome and drug ineffectiveness. It is important to monitor patients for signs of suicidal ideation and to manage potential drug interactions, especially with other psychiatric medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Paroxetine Hydrochloride.
Patients should inform their healthcare provider about any existing conditions or medications to avoid potential drug interactions. Regular monitoring and follow-up are crucial to manage the side effects and ensure the drug's effectiveness.
Paroxetine Hydrochloride has 192,057 adverse event reports on file with the FDA. A wide range of reactions are reported, including neurological, gastrointestinal, and cardiovascular issues. The volume of reports for Paroxetine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Paroxetine Hydrochloride for safety, particularly regarding serious adverse events and drug interactions. Healthcare providers should be vigilant in managing patient care and reporting adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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