POLYETHYLENE GLYCOL 4000: 984 Adverse Event Reports & Safety Profile
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984
Total FAERS Reports
246 (25.0%)
Deaths Reported
521
Hospitalizations
984
As Primary/Secondary Suspect
191
Life-Threatening
155
Disabilities
First Report: 2006 · Latest Report: 20250906
What Are the Most Common POLYETHYLENE GLYCOL 4000 Side Effects?
#1 Most Reported
Off label use
181 reports (18.4%)
#2 Most Reported
Constipation
178 reports (18.1%)
#3 Most Reported
Nausea
177 reports (18.0%)
All POLYETHYLENE GLYCOL 4000 Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 181 | 18.4% | 108 | 150 |
| Constipation | 178 | 18.1% | 120 | 150 |
| Nausea | 177 | 18.0% | 108 | 147 |
| Abdominal pain | 166 | 16.9% | 112 | 138 |
| Hyponatraemia | 154 | 15.7% | 118 | 124 |
| Vomiting | 153 | 15.6% | 134 | 113 |
| Anaemia | 148 | 15.0% | 87 | 145 |
| Drug ineffective | 146 | 14.8% | 36 | 99 |
| Abdominal distension | 125 | 12.7% | 124 | 101 |
| Ascites | 125 | 12.7% | 125 | 89 |
| Ventricular fibrillation | 124 | 12.6% | 124 | 97 |
| Appendicitis | 116 | 11.8% | 116 | 89 |
| Appendicolith | 115 | 11.7% | 115 | 88 |
| General physical health deterioration | 114 | 11.6% | 112 | 85 |
| Multiple organ dysfunction syndrome | 113 | 11.5% | 113 | 85 |
| Somnolence | 112 | 11.4% | 99 | 98 |
| Cardiogenic shock | 111 | 11.3% | 111 | 84 |
| Sepsis | 111 | 11.3% | 111 | 83 |
| Stress | 110 | 11.2% | 110 | 83 |
| Macular degeneration | 106 | 10.8% | 0 | 64 |
Who Reports POLYETHYLENE GLYCOL 4000 Side Effects? Age & Gender Data
Gender: 41.6% female, 58.4% male. Average age: 70.4 years. Most reports from: CA. View detailed demographics →
Is POLYETHYLENE GLYCOL 4000 Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 0 |
| 2007 | 3 | 0 | 3 |
| 2008 | 1 | 0 | 0 |
| 2010 | 2 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 7 | 0 | 5 |
| 2013 | 15 | 4 | 5 |
| 2014 | 10 | 0 | 9 |
| 2015 | 22 | 4 | 11 |
| 2016 | 39 | 0 | 27 |
| 2017 | 124 | 1 | 42 |
| 2018 | 105 | 10 | 53 |
| 2019 | 81 | 8 | 42 |
| 2020 | 110 | 55 | 92 |
| 2021 | 41 | 15 | 14 |
| 2022 | 31 | 10 | 5 |
| 2023 | 24 | 1 | 2 |
| 2024 | 61 | 14 | 30 |
| 2025 | 28 | 10 | 18 |
What Is POLYETHYLENE GLYCOL 4000 Used For?
| Indication | Reports |
|---|---|
| Constipation | 490 |
| Product used for unknown indication | 371 |
| Iron deficiency | 20 |
| Normochromic normocytic anaemia | 14 |
| Diabetes mellitus | 12 |
| Dyspnoea | 12 |
| Thrombosis | 12 |
| Chemotherapy side effect prophylaxis | 10 |
| Wrong patient received product | 10 |
| Type 2 diabetes mellitus | 8 |
POLYETHYLENE GLYCOL 4000 vs Alternatives: Which Is Safer?
POLYETHYLENE GLYCOL 4000 vs POLYETHYLENE GLYCOL 400\PROPYLENE GLYCOL
POLYETHYLENE GLYCOL 4000 vs POLYETHYLENE GLYCOL\POTASSIUM\SODIUM BICARBONATE
POLYETHYLENE GLYCOL 4000 vs POLYETHYLENE GLYCOL\POTASSIUM\SODIUM BICARBONATE\SODIUM
POLYETHYLENE GLYCOL 4000 vs POLYETHYLENE GLYCOLS
POLYETHYLENE GLYCOL 4000 vs POLYMYXIN B
POLYETHYLENE GLYCOL 4000 vs POLYMYXIN B\TRIMETHOPRIM
POLYETHYLENE GLYCOL 4000 vs POLYVINYL ALCOHOL\POVIDONE
POLYETHYLENE GLYCOL 4000 vs POMALIDOMIDE
POLYETHYLENE GLYCOL 4000 vs POMALYST
POLYETHYLENE GLYCOL 4000 vs PONATINIB
Official FDA Label for POLYETHYLENE GLYCOL 4000
Official prescribing information from the FDA-approved drug label.