85/100 · Critical
Manufactured by Alembic Pharmaceuticals Inc.
High Safety Concerns with Diazepam Oral Solution (Concentrate)
177,526 FDA adverse event reports analyzed
Last updated: 2026-05-12
DIAZEPAM ORAL SOLUTION (CONCENTRATE) is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alembic Pharmaceuticals Inc.. Based on analysis of 177,526 FDA adverse event reports, DIAZEPAM ORAL SOLUTION (CONCENTRATE) 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 SOLUTION (CONCENTRATE) 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 SOLUTION (CONCENTRATE).
Diazepam Oral Solution (Concentrate) 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 177,526 adverse event reports for this medication, which is primarily manufactured by Alembic Pharmaceuticals Inc..
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. Significant reports of serious adverse events, including death and intentional overdose.
High incidence of drug abuse and dependence. Multiple neurological and psychiatric adverse events reported.
Patients taking Diazepam Oral Solution (Concentrate) 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 depressants, potentially leading to respiratory depression and other serious adverse events. Warnings are issued for patients with a history of substance abuse. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Diazepam Oral Solution (Concentrate) received a safety concern score of 85/100 (high concern). This is based on a 85.0% serious event ratio across 85,912 classified reports. The score accounts for 177,526 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: 44,035, 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 85,912 classified reports for DIAZEPAM ORAL SOLUTION (CONCENTRATE):
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 depressants, potentially leading to respiratory depression and other serious adverse events. Warnings are issued for patients with a history of substance abuse.
If you are taking Diazepam Oral Solution (Concentrate), 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. Patients should strictly follow prescribed dosages and avoid alcohol and other sedatives to reduce the risk of adverse events. Inform healthcare providers about any history of substance abuse or mental health issues before starting treatment. 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 reports of serious adverse events and drug interactions. Healthcare providers should be vigilant in monitoring patients for signs of abuse and dependence.
The FDA has received approximately 177,526 adverse event reports associated with Diazepam Oral Solution (Concentrate). 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 Solution (Concentrate) 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 Solution (Concentrate).
Out of 85,912 classified reports, 73,028 (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 Solution (Concentrate) break down by patient sex as follows: Female: 44,035, 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 Solution (Concentrate) 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 Solution (Concentrate) adverse event reports is Alembic 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 Diazepam Oral Solution (Concentrate) 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 Solution (Concentrate) 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 Solution (Concentrate) 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. Significant reports of serious adverse events, including death and intentional overdose.
Key safety signals identified in Diazepam Oral Solution (Concentrate)'s adverse event data include: Over 3,000 reports of completed suicide and suicide attempts.. More than 3,000 reports of drug abuse and dependence.. Over 2,000 reports of drug toxicity and drug interactions.. 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 depressants, potentially leading to respiratory depression and other serious adverse events. Warnings are issued for patients with a history of substance abuse. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Diazepam Oral Solution (Concentrate).
Patients should strictly follow prescribed dosages and avoid alcohol and other sedatives to reduce the risk of adverse events. Inform healthcare providers about any history of substance abuse or mental health issues before starting treatment.
Diazepam Oral Solution (Concentrate) has 177,526 adverse event reports on file with the FDA. High incidence of drug abuse and dependence. The volume of reports for Diazepam Oral Solution (Concentrate) reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors reports of serious adverse events and drug interactions. Healthcare providers should be vigilant in monitoring patients for signs of abuse and dependence. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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