85/100 · Critical
Manufactured by Chartwell Governmental & Specialty RX, LLC.
Diazepam Oral: High Safety Concerns with Significant Serious Reactions
177,537 FDA adverse event reports analyzed
Last updated: 2026-05-12
DIAZEPAM ORAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Chartwell Governmental & Specialty RX, LLC.. Based on analysis of 177,537 FDA adverse event reports, DIAZEPAM ORAL 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 DIAZEPAM ORAL include TOXICITY TO VARIOUS AGENTS, DRUG ABUSE, DRUG INEFFECTIVE, NAUSEA, COMPLETED SUICIDE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DIAZEPAM ORAL.
Diazepam Oral 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 177,537 adverse event reports for this medication, which is primarily manufactured by Chartwell Governmental & Specialty Rx, Llc..
The most commonly reported adverse events include Toxicity To Various Agents, Drug Abuse, Drug Ineffective. Of classified reports, 85.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High frequency of serious reactions including death, suicide, and overdose.
Significant drug abuse and dependence reports. Common side effects include dizziness, fatigue, and nausea. Multiple reports of respiratory issues and cardiac arrest. A high number of adverse reactions related to misuse and intentional overdose.
Patients taking Diazepam Oral should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Diazepam can interact with other sedatives and CNS depressants, increasing the risk of respiratory depression and other adverse effects. Warnings include the risk of drug abuse and dependence. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Diazepam Oral received a safety concern score of 85/100 (high concern). This is based on a 85.0% serious event ratio across 85,914 classified reports. The score accounts for 177,537 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: 44,037, Male: 33,873, Unknown: 508. The most frequently reported age groups are age 52 (1,605 reports), age 50 (1,398 reports), age 49 (1,369 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 85,914 classified reports for DIAZEPAM ORAL:
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.
Diazepam can interact with other sedatives and CNS depressants, increasing the risk of respiratory depression and other adverse effects. Warnings include the risk of drug abuse and dependence.
If you are taking Diazepam Oral, here are important things to know. The most commonly reported side effects include toxicity to various agents, drug abuse, drug ineffective, nausea, completed suicide. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Do not use diazepam for longer than prescribed or at higher doses without medical supervision. Seek immediate medical attention if experiencing severe side effects such as respiratory issues or suicidal thoughts. Do not share diazepam with others, as it can be highly addictive. 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 diazepam due to its high safety concerns, particularly for serious reactions and drug abuse. Regular monitoring and reporting of adverse events are required.
The FDA has received approximately 177,537 adverse event reports associated with Diazepam Oral. 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 Diazepam Oral include Toxicity To Various Agents, Drug Abuse, Drug Ineffective, Nausea, Completed Suicide. By volume, the top reported reactions are: Toxicity To Various Agents (8,536 reports), Drug Abuse (5,990 reports), Drug Ineffective (4,806 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Diazepam Oral.
Out of 85,914 classified reports, 73,030 (85.0%) were classified as serious and 12,884 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 Diazepam Oral break down by patient sex as follows: Female: 44,037, Male: 33,873, Unknown: 508. 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 Diazepam Oral adverse events are: age 52: 1,605 reports, age 50: 1,398 reports, age 49: 1,369 reports, age 53: 1,245 reports, age 47: 1,220 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 Diazepam Oral adverse event reports is Chartwell Governmental & Specialty Rx, 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 Diazepam Oral include: Fatigue, Drug Interaction, Somnolence, Off Label Use, Anxiety. 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 Diazepam Oral 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.
Diazepam Oral 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. High frequency of serious reactions including death, suicide, and overdose.
Key safety signals identified in Diazepam Oral's adverse event data include: Over 3,000 reports of completed suicide and suicide attempts.. More than 8,000 reports of drug abuse and dependence.. Over 3,000 reports of drug ineffectiveness.. Multiple reports of respiratory depression and arrest.. High number of serious reactions including death and overdose.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Diazepam can interact with other sedatives and CNS depressants, increasing the risk of respiratory depression and other adverse effects. Warnings include the risk of drug abuse and dependence. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Diazepam Oral.
Do not use diazepam for longer than prescribed or at higher doses without medical supervision. Seek immediate medical attention if experiencing severe side effects such as respiratory issues or suicidal thoughts. Do not share diazepam with others, as it can be highly addictive.
Diazepam Oral has 177,537 adverse event reports on file with the FDA. Significant drug abuse and dependence reports. The volume of reports for Diazepam Oral reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors diazepam due to its high safety concerns, particularly for serious reactions and drug abuse. Regular monitoring and reporting of adverse events are required. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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