82/100 · Critical
Manufactured by H2-Pharma, LLC
Clonazepam Adverse Events Show High Incidence of Serious Reactions
346,085 FDA adverse event reports analyzed
Last updated: 2026-05-12
CLONAZEPAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by H2-Pharma, LLC. Based on analysis of 346,085 FDA adverse event reports, CLONAZEPAM 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 CLONAZEPAM include DRUG INEFFECTIVE, FATIGUE, NAUSEA, ANXIETY, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLONAZEPAM.
Clonazepam 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 346,085 adverse event reports for this medication, which is primarily manufactured by H2-Pharma, Llc.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 68.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Clonazepam reports include a high number of serious adverse events, particularly related to respiratory issues and suicidal behavior.
The most common reactions are fatigue, nausea, and anxiety, indicating a broad spectrum of side effects. Drug interactions and overdose are also frequently reported, highlighting the need for careful monitoring.
Patients taking Clonazepam should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Clonazepam can interact with other drugs, potentially leading to increased sedation or respiratory depression. Overdose is a significant risk and can be fatal. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Clonazepam received a safety concern score of 82/100 (high concern). This is based on a 68.0% serious event ratio across 155,108 classified reports. The score accounts for 346,085 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: 93,692, Male: 50,931, Unknown: 291. The most frequently reported age groups are age 54 (3,038 reports), age 65 (2,555 reports), age 52 (2,415 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 155,108 classified reports for CLONAZEPAM:
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.
Clonazepam can interact with other drugs, potentially leading to increased sedation or respiratory depression. Overdose is a significant risk and can be fatal.
If you are taking Clonazepam, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, nausea, anxiety, headache. 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 regimen without consulting a healthcare provider. Be aware of potential drug interactions and inform your doctor 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.
Regulators closely monitor Clonazepam due to its high rate of serious adverse events, particularly related to respiratory issues and suicidal behavior.
The FDA has received approximately 346,085 adverse event reports associated with Clonazepam. 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 Clonazepam include Drug Ineffective, Fatigue, Nausea, Anxiety, Headache. By volume, the top reported reactions are: Drug Ineffective (13,609 reports), Fatigue (10,235 reports), Nausea (9,563 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Clonazepam.
Out of 155,108 classified reports, 105,489 (68.0%) were classified as serious and 49,619 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 Clonazepam break down by patient sex as follows: Female: 93,692, Male: 50,931, Unknown: 291. 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 Clonazepam adverse events are: age 54: 3,038 reports, age 65: 2,555 reports, age 52: 2,415 reports, age 57: 2,415 reports, age 56: 2,393 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 Clonazepam adverse event reports is H2-Pharma, 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 Clonazepam include: Depression, Pain, Off Label Use, Dizziness, 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 Clonazepam 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.
Clonazepam 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. Clonazepam reports include a high number of serious adverse events, particularly related to respiratory issues and suicidal behavior.
Key safety signals identified in Clonazepam's adverse event data include: High incidence of serious reactions (68%). Frequent reports of respiratory issues and suicidal behavior. Common side effects include fatigue, nausea, and anxiety. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Clonazepam can interact with other drugs, potentially leading to increased sedation or respiratory depression. Overdose is a significant risk and can be fatal. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Clonazepam.
Always follow prescribed dosages and do not alter the regimen without consulting a healthcare provider. Be aware of potential drug interactions and inform your doctor of all medications you are taking.
Clonazepam has 346,085 adverse event reports on file with the FDA. The most common reactions are fatigue, nausea, and anxiety, indicating a broad spectrum of side effects. The volume of reports for Clonazepam reflects both the drug's usage level and the vigilance of the reporting community.
Regulators closely monitor Clonazepam due to its high rate of serious adverse events, particularly related to respiratory issues and suicidal behavior. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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