85/100 · Critical
Manufactured by Roche Laboratories Inc.
Diazepam Adverse Events Show High Seriousness and Diverse Reactions
248,786 FDA adverse event reports analyzed
Last updated: 2026-05-12
DIAZEPAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Roche Laboratories Inc.. Based on analysis of 248,786 FDA adverse event reports, DIAZEPAM 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 include TOXICITY TO VARIOUS AGENTS, DRUG INEFFECTIVE, DRUG ABUSE, NAUSEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DIAZEPAM.
Diazepam 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 248,786 adverse event reports for this medication, which is primarily manufactured by Roche Laboratories Inc..
The most commonly reported adverse events include Toxicity To Various Agents, Drug Ineffective, Drug Abuse. Of classified reports, 80.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (80.9%) indicates significant safety concerns.
A wide range of reactions, including toxicity, drug abuse, and suicidal ideation, suggests a complex safety profile. Overdose and intentional misuse are common, highlighting the need for strict monitoring.
Patients taking Diazepam should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Diazepam can interact with other drugs, potentially leading to increased toxicity or reduced efficacy. Warnings include the risk of drug interactions, especially with other central nervous system depressants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Diazepam received a safety concern score of 85/100 (high concern). This is based on a 80.9% serious event ratio across 117,840 classified reports. The score accounts for 248,786 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: 62,465, Male: 45,577, Unknown: 560. The most frequently reported age groups are age 52 (2,010 reports), age 50 (1,851 reports), age 49 (1,817 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 117,840 classified reports for DIAZEPAM:
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 drugs, potentially leading to increased toxicity or reduced efficacy. Warnings include the risk of drug interactions, especially with other central nervous system depressants.
If you are taking Diazepam, here are important things to know. The most commonly reported side effects include toxicity to various agents, drug ineffective, drug abuse, nausea, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow prescribed dosages and avoid self-adjustment or discontinuation without consulting a healthcare provider. Inform healthcare providers about all medications and supplements being used to avoid potential drug interactions. 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.
Regulatory authorities continue to monitor diazepam closely due to its high incidence of serious adverse events, particularly related to overdose and drug interactions.
The FDA has received approximately 248,786 adverse event reports associated with Diazepam. 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 include Toxicity To Various Agents, Drug Ineffective, Drug Abuse, Nausea, Fatigue. By volume, the top reported reactions are: Toxicity To Various Agents (9,167 reports), Drug Ineffective (7,078 reports), Drug Abuse (7,019 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.
Out of 117,840 classified reports, 95,389 (80.9%) were classified as serious and 22,451 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 break down by patient sex as follows: Female: 62,465, Male: 45,577, Unknown: 560. 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 adverse events are: age 52: 2,010 reports, age 50: 1,851 reports, age 49: 1,817 reports, age 53: 1,743 reports, age 57: 1,692 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 adverse event reports is Roche Laboratories 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 Diazepam include: Pain, Anxiety, Headache, Somnolence, Off Label Use. 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 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 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 percentage of serious adverse events (80.9%) indicates significant safety concerns.
Key safety signals identified in Diazepam's adverse event data include: Over 39,000 reports of death and over 41,000 reports of drug interaction highlight critical safety signals.. Serious adverse events account for 80.9% of all reports, indicating a high risk of severe outcomes.. Multiple reports of suicidal ideation and completed suicide underscore the mental health risks associated with diazepam.. 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 drugs, potentially leading to increased toxicity or reduced efficacy. Warnings include the risk of drug interactions, especially with other central nervous system depressants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Diazepam.
Patients should strictly follow prescribed dosages and avoid self-adjustment or discontinuation without consulting a healthcare provider. Inform healthcare providers about all medications and supplements being used to avoid potential drug interactions.
Diazepam has 248,786 adverse event reports on file with the FDA. A wide range of reactions, including toxicity, drug abuse, and suicidal ideation, suggests a complex safety profile. The volume of reports for Diazepam reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory authorities continue to monitor diazepam closely due to its high incidence of serious adverse events, particularly related to overdose and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with DIAZEPAM:
Drugs related to DIAZEPAM based on therapeutic use, drug class, or shared indications: