85/100 · Critical
Manufactured by BluePoint Laboratories
Polyethylene Glycol Adverse Reactions: High Serious Event Rate
20,932 FDA adverse event reports analyzed
Last updated: 2026-05-12
POLYETHYLENE GLYCOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by BluePoint Laboratories. Based on analysis of 20,932 FDA adverse event reports, POLYETHYLENE GLYCOL 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 POLYETHYLENE GLYCOL include FEBRILE NEUTROPENIA, NAUSEA, FATIGUE, DYSPNOEA, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for POLYETHYLENE GLYCOL.
Polyethylene Glycol 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 20,932 adverse event reports for this medication, which is primarily manufactured by Bluepoint Laboratories.
The most commonly reported adverse events include Febrile Neutropenia, Nausea, Fatigue. Of classified reports, 82.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Polyethylene glycol is associated with a high rate of serious adverse events, particularly febrile neutropenia and acute kidney injury.
The most common reactions include nausea, fatigue, and dyspnoea, indicating gastrointestinal and respiratory issues. A significant number of reports involve chronic kidney disease and renal failure, highlighting potential renal toxicity. Drug interactions and off-label use are also reported, suggesting caution in its use. Death is reported in a notable number of cases, indicating severe adverse outcomes.
Patients taking Polyethylene Glycol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Polyethylene glycol may interact with other drugs, and its use in unapproved indications should be avoided to prevent adverse reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Polyethylene Glycol received a safety concern score of 85/100 (high concern). This is based on a 82.6% serious event ratio across 10,388 classified reports. The score accounts for 20,932 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: 5,295, Male: 4,562, Unknown: 9. The most frequently reported age groups are age 71 (186 reports), age 76 (177 reports), age 69 (173 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 10,388 classified reports for POLYETHYLENE GLYCOL:
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.
Polyethylene glycol may interact with other drugs, and its use in unapproved indications should be avoided to prevent adverse reactions.
If you are taking Polyethylene Glycol, here are important things to know. The most commonly reported side effects include febrile neutropenia, nausea, fatigue, dyspnoea, vomiting. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of serious adverse events such as febrile neutropenia, acute kidney injury, and respiratory distress. Use polyethylene glycol only as directed and avoid off-label use to reduce the risk of adverse reactions. 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 adverse events for polyethylene glycol, and regulatory actions may be taken based on ongoing safety data.
The FDA has received approximately 20,932 adverse event reports associated with Polyethylene Glycol. 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 Polyethylene Glycol include Febrile Neutropenia, Nausea, Fatigue, Dyspnoea, Vomiting. By volume, the top reported reactions are: Febrile Neutropenia (796 reports), Nausea (644 reports), Fatigue (562 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Polyethylene Glycol.
Out of 10,388 classified reports, 8,582 (82.6%) were classified as serious and 1,806 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 Polyethylene Glycol break down by patient sex as follows: Female: 5,295, Male: 4,562, Unknown: 9. 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 Polyethylene Glycol adverse events are: age 71: 186 reports, age 76: 177 reports, age 69: 173 reports, age 66: 172 reports, age 67: 167 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 Polyethylene Glycol adverse event reports is Bluepoint Laboratories. 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 Polyethylene Glycol include: Diarrhoea, Acute Kidney Injury, Off Label Use, Chronic Kidney Disease, Constipation. 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 Polyethylene Glycol 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.
Polyethylene Glycol 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. Polyethylene glycol is associated with a high rate of serious adverse events, particularly febrile neutropenia and acute kidney injury.
Key safety signals identified in Polyethylene Glycol's adverse event data include: Febrile neutropenia and acute kidney injury are key safety signals, with high counts and serious nature.. Chronic kidney disease and renal failure are frequent and serious outcomes.. Drug interactions and off-label use are reported, indicating potential misuse or incompatibility.. Death is a significant safety signal, with multiple reports indicating severe adverse outcomes.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Polyethylene glycol may interact with other drugs, and its use in unapproved indications should be avoided to prevent adverse reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Polyethylene Glycol.
Monitor for signs of serious adverse events such as febrile neutropenia, acute kidney injury, and respiratory distress. Use polyethylene glycol only as directed and avoid off-label use to reduce the risk of adverse reactions.
Polyethylene Glycol has 20,932 adverse event reports on file with the FDA. The most common reactions include nausea, fatigue, and dyspnoea, indicating gastrointestinal and respiratory issues. The volume of reports for Polyethylene Glycol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors adverse events for polyethylene glycol, and regulatory actions may be taken based on ongoing safety data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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