92/100 · Critical
Manufactured by Ecolab Inc.
Alcohol Adverse Events: High Seriousness and Diverse Reactions
152,732 FDA adverse event reports analyzed
Last updated: 2026-05-12
ALCOHOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Ecolab Inc.. Based on analysis of 152,732 FDA adverse event reports, ALCOHOL has a safety score of 92 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 ALCOHOL include COMPLETED SUICIDE, TOXICITY TO VARIOUS AGENTS, DRUG ABUSE, DEATH, OVERDOSE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALCOHOL.
Alcohol has a safety concern score of 92 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 152,732 adverse event reports for this medication, which is primarily manufactured by Ecolab Inc..
The most commonly reported adverse events include Completed Suicide, Toxicity To Various Agents, Drug Abuse. Of classified reports, 96.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with over 96% classified as such.
A wide range of reactions are reported, indicating diverse and complex effects. Overdose and suicide-related events are among the most frequent and severe.
Patients taking Alcohol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Alcohol can interact with numerous medications, potentially exacerbating adverse effects. Warnings are issued for individuals with pre-existing conditions or those at risk of overdose or addiction. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Alcohol received a safety concern score of 92/100 (high concern). This is based on a 96.3% serious event ratio across 37,078 classified reports. The score accounts for 152,732 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: Male: 17,058, Female: 16,835, Unknown: 98. The most frequently reported age groups are age 44 (1,854 reports), age 40 (1,177 reports), age 43 (1,025 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 37,078 classified reports for ALCOHOL:
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.
Alcohol can interact with numerous medications, potentially exacerbating adverse effects. Warnings are issued for individuals with pre-existing conditions or those at risk of overdose or addiction.
If you are taking Alcohol, here are important things to know. The most commonly reported side effects include completed suicide, toxicity to various agents, drug abuse, death, overdose. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Avoid alcohol if you have a history of substance abuse or are at risk of overdose. Be cautious when mixing alcohol with prescription medications to avoid adverse 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 bodies closely monitor alcohol consumption due to its high risk of serious adverse events, particularly in individuals with pre-existing health conditions or a history of substance abuse.
The FDA has received approximately 152,732 adverse event reports associated with Alcohol. 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 Alcohol include Completed Suicide, Toxicity To Various Agents, Drug Abuse, Death, Overdose. By volume, the top reported reactions are: Completed Suicide (7,972 reports), Toxicity To Various Agents (7,415 reports), Drug Abuse (6,760 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Alcohol.
Out of 37,078 classified reports, 35,699 (96.3%) were classified as serious and 1,379 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 Alcohol break down by patient sex as follows: Male: 17,058, Female: 16,835, Unknown: 98. 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 Alcohol adverse events are: age 44: 1,854 reports, age 40: 1,177 reports, age 43: 1,025 reports, age 39: 743 reports, age 53: 687 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 Alcohol adverse event reports is Ecolab 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 Alcohol include: Cardio-Respiratory Arrest, Intentional Overdose, Confusional State, Vomiting, Fatigue. 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 Alcohol 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.
Alcohol has a safety concern score of 92 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. The majority of adverse events are serious, with over 96% classified as such.
Key safety signals identified in Alcohol's adverse event data include: High frequency of serious reactions like death, toxicity, and cardiac arrest.. Diverse reactions including neurological, gastrointestinal, and respiratory issues.. Significant number of reports related to drug abuse and intentional misuse.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Alcohol can interact with numerous medications, potentially exacerbating adverse effects. Warnings are issued for individuals with pre-existing conditions or those at risk of overdose or addiction. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Alcohol.
Avoid alcohol if you have a history of substance abuse or are at risk of overdose. Be cautious when mixing alcohol with prescription medications to avoid adverse interactions.
Alcohol has 152,732 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating diverse and complex effects. The volume of reports for Alcohol reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory bodies closely monitor alcohol consumption due to its high risk of serious adverse events, particularly in individuals with pre-existing health conditions or a history of substance abuse. 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 ALCOHOL:
Drugs related to ALCOHOL based on therapeutic use, drug class, or shared indications: