85/100 · Critical
Manufactured by Fresenius Kabi USA, LLC
Propofol Adverse Events: High Seriousness and Diverse Reactions
57,130 FDA adverse event reports analyzed
Last updated: 2026-05-12
PROPOFOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. Based on analysis of 57,130 FDA adverse event reports, PROPOFOL 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 PROPOFOL include HYPOTENSION, DRUG INEFFECTIVE, ANAPHYLACTIC SHOCK, CARDIAC ARREST, ANAPHYLACTIC REACTION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PROPOFOL.
Propofol 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 57,130 adverse event reports for this medication, which is primarily manufactured by Fresenius Kabi Usa, Llc.
The most commonly reported adverse events include Hypotension, Drug Ineffective, Anaphylactic Shock. Of classified reports, 93.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Propofol has a high rate of serious adverse events, with over 93% of reported reactions being serious.
The drug is associated with a wide range of reactions, including cardiovascular, respiratory, and neurological issues. Cardiac arrest and anaphylactic reactions are among the most frequent and severe adverse events.
Patients taking Propofol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Propofol can interact with other drugs, potentially leading to adverse effects. Warnings include the risk of drug interactions and the need for careful monitoring. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Propofol received a safety concern score of 85/100 (high concern). This is based on a 93.8% serious event ratio across 35,039 classified reports. The score accounts for 57,130 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: 15,846, Male: 15,311, Unknown: 231. The most frequently reported age groups are age 67 (628 reports), age 54 (526 reports), age 60 (515 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 35,039 classified reports for PROPOFOL:
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.
Propofol can interact with other drugs, potentially leading to adverse effects. Warnings include the risk of drug interactions and the need for careful monitoring.
If you are taking Propofol, here are important things to know. The most commonly reported side effects include hypotension, drug ineffective, anaphylactic shock, cardiac arrest, anaphylactic reaction. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Ensure that Propofol is administered only by trained medical professionals in appropriate settings. Monitor patients closely for signs of respiratory and cardiovascular complications. 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 oversight is ongoing, with frequent updates to safety information and warnings. Healthcare providers should stay informed about the latest safety data.
The FDA has received approximately 57,130 adverse event reports associated with Propofol. 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 Propofol include Hypotension, Drug Ineffective, Anaphylactic Shock, Cardiac Arrest, Anaphylactic Reaction. By volume, the top reported reactions are: Hypotension (2,826 reports), Drug Ineffective (2,674 reports), Anaphylactic Shock (1,969 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Propofol.
Out of 35,039 classified reports, 32,856 (93.8%) were classified as serious and 2,183 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 Propofol break down by patient sex as follows: Female: 15,846, Male: 15,311, Unknown: 231. 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 Propofol adverse events are: age 67: 628 reports, age 54: 526 reports, age 60: 515 reports, age 68: 515 reports, age 63: 512 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 Propofol adverse event reports is Fresenius Kabi Usa, 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 Propofol include: Off Label Use, Drug Interaction, Bradycardia, Tachycardia, Pyrexia. 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 Propofol 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.
Propofol 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. Propofol has a high rate of serious adverse events, with over 93% of reported reactions being serious.
Key safety signals identified in Propofol's adverse event data include: Cardiac arrest and anaphylactic reactions are key safety signals, with high counts and severity.. Propofol is frequently reported to cause respiratory depression and failure, indicating potential respiratory risks.. Serious reactions such as sepsis, circulatory collapse, and renal failure are also significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Propofol can interact with other drugs, potentially leading to adverse effects. Warnings include the risk of drug interactions and the need for careful monitoring. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Propofol.
Ensure that Propofol is administered only by trained medical professionals in appropriate settings. Monitor patients closely for signs of respiratory and cardiovascular complications.
Propofol has 57,130 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including cardiovascular, respiratory, and neurological issues. The volume of reports for Propofol reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with frequent updates to safety information and warnings. Healthcare providers should stay informed about the latest safety data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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