65/100 · Elevated
Manufactured by Bayer HealthCare LLC.
Polyethylene Glycol 3350 Reports Show High Incidence of Product Use Issues and Gastrointestinal Symptoms
173,431 FDA adverse event reports analyzed
Last updated: 2026-05-12
POLYETHYLENE GLYCOL 3350 is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare LLC.. Based on analysis of 173,431 FDA adverse event reports, POLYETHYLENE GLYCOL 3350 has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for POLYETHYLENE GLYCOL 3350 include PRODUCT USE ISSUE, DRUG INEFFECTIVE, OFF LABEL USE, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for POLYETHYLENE GLYCOL 3350.
Polyethylene Glycol 3350 has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 173,431 adverse event reports for this medication, which is primarily manufactured by Bayer Healthcare Llc..
The most commonly reported adverse events include Product Use Issue, Drug Ineffective, Off Label Use. Of classified reports, 40.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reports involve product use issues and gastrointestinal symptoms, indicating potential misuse or side effects.
Serious adverse events, such as death and sepsis, are reported but at a lower frequency compared to non-serious events. The high volume of reports suggests a significant safety concern, particularly for elderly patients. Most reports are from male and female patients over 70 years old, indicating a potential age-related risk.
Patients taking Polyethylene Glycol 3350 should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs are not commonly reported, but patients should be cautious when using Polyethylene Glycol 3350 with other medications, especially those affecting gastrointestinal function. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Polyethylene Glycol 3350 received a safety concern score of 65/100 (elevated concern). This is based on a 40.3% serious event ratio across 91,627 classified reports. The score accounts for 173,431 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 50,438, Male: 32,647, Unknown: 255. The most frequently reported age groups are age 80 (1,384 reports), age 72 (1,304 reports), age 76 (1,298 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 91,627 classified reports for POLYETHYLENE GLYCOL 3350:
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.
Interactions with other drugs are not commonly reported, but patients should be cautious when using Polyethylene Glycol 3350 with other medications, especially those affecting gastrointestinal function.
If you are taking Polyethylene Glycol 3350, here are important things to know. The most commonly reported side effects include product use issue, drug ineffective, off label use, diarrhoea, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the prescribed dosage and administration instructions carefully to avoid misuse and potential side effects. Report any unusual symptoms or adverse reactions to your healthcare provider immediately. 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 continues to monitor the safety of Polyethylene Glycol 3350, and updates will be provided as more data becomes available.
The FDA has received approximately 173,431 adverse event reports associated with Polyethylene Glycol 3350. 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 3350 include Product Use Issue, Drug Ineffective, Off Label Use, Diarrhoea, Nausea. By volume, the top reported reactions are: Product Use Issue (9,862 reports), Drug Ineffective (9,562 reports), Off Label Use (8,885 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 3350.
Out of 91,627 classified reports, 36,961 (40.3%) were classified as serious and 54,666 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 3350 break down by patient sex as follows: Female: 50,438, Male: 32,647, Unknown: 255. 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 3350 adverse events are: age 80: 1,384 reports, age 72: 1,304 reports, age 76: 1,298 reports, age 74: 1,294 reports, age 70: 1,287 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 3350 adverse event reports is Bayer Healthcare 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 Polyethylene Glycol 3350 include: Constipation, Fatigue, Product Use In Unapproved Indication, Vomiting, Pain. 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 3350 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 3350 has a safety concern score of 65 out of 100 (elevated 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 reports involve product use issues and gastrointestinal symptoms, indicating potential misuse or side effects.
Key safety signals identified in Polyethylene Glycol 3350's adverse event data include: Product use issues are the most common reaction, accounting for nearly 10% of all reports.. Gastrointestinal symptoms like diarrhea and nausea are frequently reported, suggesting potential side effects.. Serious adverse events, including death and sepsis, are reported but at a lower rate compared to non-serious events.. The majority of reports are from patients over 70, indicating potential age-related risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs are not commonly reported, but patients should be cautious when using Polyethylene Glycol 3350 with other medications, especially those affecting gastrointestinal function. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Polyethylene Glycol 3350.
Follow the prescribed dosage and administration instructions carefully to avoid misuse and potential side effects. Report any unusual symptoms or adverse reactions to your healthcare provider immediately.
Polyethylene Glycol 3350 has 173,431 adverse event reports on file with the FDA. Serious adverse events, such as death and sepsis, are reported but at a lower frequency compared to non-serious events. The volume of reports for Polyethylene Glycol 3350 reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Polyethylene Glycol 3350, and updates will be provided as more data becomes available. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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