85/100 · Critical
Manufactured by Organon LLC
High Safety Concerns with Mirtazapine, Particularly for Serious Reactions
174,805 FDA adverse event reports analyzed
Last updated: 2026-05-12
MIRTAZAPINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. Based on analysis of 174,805 FDA adverse event reports, MIRTAZAPINE 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 MIRTAZAPINE include NAUSEA, FATIGUE, DRUG INEFFECTIVE, FALL, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MIRTAZAPINE.
Mirtazapine 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 174,805 adverse event reports for this medication, which is primarily manufactured by Organon Llc.
The most commonly reported adverse events include Nausea, Fatigue, Drug Ineffective. Of classified reports, 83.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Mirtazapine has a high incidence of serious adverse reactions, with over 73,550 serious reports out of 174,805 total reports.
The most common reactions include nausea, fatigue, and drug ineffectiveness, which are reported in over 4,000 cases each. Serious reactions such as death, pneumonia, and suicidal ideation are frequently reported, indicating significant safety concerns.
Patients taking Mirtazapine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Mirtazapine can interact with various drugs, including other antidepressants and sedatives, and can lead to serious adverse events such as serotonin syndrome and QT prolongation. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Mirtazapine received a safety concern score of 85/100 (high concern). This is based on a 83.8% serious event ratio across 87,736 classified reports. The score accounts for 174,805 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: 46,485, Male: 34,181, Unknown: 236. The most frequently reported age groups are age 59 (1,286 reports), age 72 (1,283 reports), age 68 (1,236 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 87,736 classified reports for MIRTAZAPINE:
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.
Mirtazapine can interact with various drugs, including other antidepressants and sedatives, and can lead to serious adverse events such as serotonin syndrome and QT prolongation.
If you are taking Mirtazapine, here are important things to know. The most commonly reported side effects include nausea, fatigue, drug ineffective, fall, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of suicidal ideation and behavior, especially during the first few weeks of treatment. Avoid driving or operating heavy machinery until the effects of the medication are known, as dizziness and fatigue are common. 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 Mirtazapine due to its high rate of serious adverse events, and healthcare providers should be vigilant in monitoring patients for signs of serious reactions.
The FDA has received approximately 174,805 adverse event reports associated with Mirtazapine. 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 Mirtazapine include Nausea, Fatigue, Drug Ineffective, Fall, Diarrhoea. By volume, the top reported reactions are: Nausea (4,837 reports), Fatigue (4,714 reports), Drug Ineffective (4,596 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Mirtazapine.
Out of 87,736 classified reports, 73,550 (83.8%) were classified as serious and 14,186 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 Mirtazapine break down by patient sex as follows: Female: 46,485, Male: 34,181, Unknown: 236. 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 Mirtazapine adverse events are: age 59: 1,286 reports, age 72: 1,283 reports, age 68: 1,236 reports, age 65: 1,235 reports, age 69: 1,229 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 Mirtazapine adverse event reports is Organon 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 Mirtazapine include: Off Label Use, Toxicity To Various Agents, Anxiety, Dizziness, 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 Mirtazapine 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.
Mirtazapine 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. Mirtazapine has a high incidence of serious adverse reactions, with over 73,550 serious reports out of 174,805 total reports.
Key safety signals identified in Mirtazapine's adverse event data include: High rate of serious adverse events (83.8%). Multiple reports of suicidal ideation and completed suicide. Significant number of drug interactions and overdose reports. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Mirtazapine can interact with various drugs, including other antidepressants and sedatives, and can lead to serious adverse events such as serotonin syndrome and QT prolongation. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Mirtazapine.
Patients should be closely monitored for signs of suicidal ideation and behavior, especially during the first few weeks of treatment. Avoid driving or operating heavy machinery until the effects of the medication are known, as dizziness and fatigue are common.
Mirtazapine has 174,805 adverse event reports on file with the FDA. The most common reactions include nausea, fatigue, and drug ineffectiveness, which are reported in over 4,000 cases each. The volume of reports for Mirtazapine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Mirtazapine due to its high rate of serious adverse events, and healthcare providers should be vigilant in monitoring patients for signs of serious reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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