85/100 · Critical
Manufactured by Mylan Pharmaceuticals Inc.
Serious Adverse Events Common with Paroxetine Hydrochloride Hemihydrate
66,661 FDA adverse event reports analyzed
Last updated: 2026-05-12
PAROXETINE HYDROCHLORIDE HEMIHYDRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Mylan Pharmaceuticals Inc.. Based on analysis of 66,661 FDA adverse event reports, PAROXETINE HYDROCHLORIDE HEMIHYDRATE 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 HYDROCHLORIDE HEMIHYDRATE 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 HYDROCHLORIDE HEMIHYDRATE.
Paroxetine Hydrochloride Hemihydrate 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 66,661 adverse event reports for this medication, which is primarily manufactured by Mylan Pharmaceuticals Inc..
The most commonly reported adverse events include Drug Ineffective, Drug Interaction, Fatigue. Of classified reports, 83.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, including death, suicide, and serotonin syndrome, are frequently reported.
Drug interactions and ineffective drug performance are also significant concerns. Common side effects include nausea, fatigue, and dizziness, which can impact quality of life. Overdose and intentional self-harm are notable risks, especially in higher doses or with misuse. The drug is often used off-label, which may increase the risk of adverse events.
Patients taking Paroxetine Hydrochloride Hemihydrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Paroxetine Hydrochloride Hemihydrate can interact with other medications, and its use should be monitored for potential drug interactions. Patients should avoid alcohol and other CNS depressants to prevent adverse effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Paroxetine Hydrochloride Hemihydrate received a safety concern score of 85/100 (high concern). This is based on a 83.5% serious event ratio across 31,974 classified reports. The score accounts for 66,661 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: 18,527, Male: 10,471, Unknown: 83. The most frequently reported age groups are age 68 (503 reports), age 65 (502 reports), age 60 (500 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 31,974 classified reports for PAROXETINE HYDROCHLORIDE HEMIHYDRATE:
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 Hemihydrate can interact with other medications, and its use should be monitored for potential drug interactions. Patients should avoid alcohol and other CNS depressants to prevent adverse effects.
If you are taking Paroxetine Hydrochloride Hemihydrate, 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. Always follow prescribed dosages and do not alter the medication without consulting a healthcare provider. Report any unusual symptoms or side effects to your healthcare provider immediately. Do not use the drug for off-label purposes unless specifically directed by a healthcare provider. 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 the safety of Paroxetine Hydrochloride Hemihydrate, and updates are regularly issued. Healthcare providers should stay informed about the latest safety information and guidelines.
The FDA has received approximately 66,661 adverse event reports associated with Paroxetine Hydrochloride Hemihydrate. 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 Hemihydrate include Drug Ineffective, Drug Interaction, Fatigue, Nausea, Toxicity To Various Agents. By volume, the top reported reactions are: Drug Ineffective (1,890 reports), Drug Interaction (1,823 reports), Fatigue (1,764 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 Hemihydrate.
Out of 31,974 classified reports, 26,708 (83.5%) were classified as serious and 5,266 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 Hemihydrate break down by patient sex as follows: Female: 18,527, Male: 10,471, 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 Hydrochloride Hemihydrate adverse events are: age 68: 503 reports, age 65: 502 reports, age 60: 500 reports, age 53: 498 reports, age 54: 492 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 Hemihydrate adverse event reports is Mylan Pharmaceuticals 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 Hydrochloride Hemihydrate include: Anxiety, Diarrhoea, Headache, Dizziness, Fall. 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 Hemihydrate 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 Hemihydrate 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, including death, suicide, and serotonin syndrome, are frequently reported.
Key safety signals identified in Paroxetine Hydrochloride Hemihydrate's adverse event data include: Serious adverse events such as death, suicide, and serotonin syndrome are common.. Drug ineffectiveness and interactions are frequently reported.. Overdose and intentional self-harm are significant safety signals.. Off-label use is prevalent, potentially increasing risk.. Reports of acute kidney injury and chronic kidney disease are concerning.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Paroxetine Hydrochloride Hemihydrate can interact with other medications, and its use should be monitored for potential drug interactions. Patients should avoid alcohol and other CNS depressants to prevent adverse effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Paroxetine Hydrochloride Hemihydrate.
Always follow prescribed dosages and do not alter the medication without consulting a healthcare provider. Report any unusual symptoms or side effects to your healthcare provider immediately. Do not use the drug for off-label purposes unless specifically directed by a healthcare provider.
Paroxetine Hydrochloride Hemihydrate has 66,661 adverse event reports on file with the FDA. Drug interactions and ineffective drug performance are also significant concerns. The volume of reports for Paroxetine Hydrochloride Hemihydrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Paroxetine Hydrochloride Hemihydrate, and updates are regularly issued. Healthcare providers should stay informed about the latest safety information and guidelines. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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