Generic name
Polyethylene glycol 4000: adverse event reports filed with FDA
568 reports list it as a suspect or interacting product, 2008–2026.
- 568
- reports as suspect product
- 0% of all reports · about 32 a year
- 59
- reports, 12 months to June 2026
- 119 in the 12 months before
- 100%
- marked serious by the reporter
- 57.4% across all reports
- 38.4%
- record death among outcomes, as reported
- 218 reports · not verified by FDA
Between September 2008 and June 2026, 568 adverse event reports received by FDA list polyethylene glycol 4000, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (1,270) are left out of every figure here.
In the 12 months to June 2026, 59 reports listed it, down 50% from 119 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 32 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded off label use (32%), nausea (31.2%) and constipation (29.9%). A report can list several reactions, so shares add to more than 100%; 239 different terms appear across these reports. Off label use is recorded in 32% of these reports, against 4.1% of all reports in the database.
100% of the reports are marked serious by the reporter; 38.4% record death among the outcomes and 53.7% record hospitalisation, as reported. 47% of the reports came from other health professionals, and the largest patient age group is 75 and over (40.8%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Polyethylene glycol 4000 reports recording the termall reports in the database
- Off label useused for a purpose or in a way not on the label32%182
- Nauseafeeling sick31.2%177
- Constipationconstipation29.9%170
- Abdominal painstomach or belly pain28.3%161
- Drug ineffectivethe medicine did not work as expected25.5%145
- Vomitingbeing sick24.6%140
- Anaemialow red blood cells23.8%135
- Ascitesfluid in the abdomen22.9%130
- Ventricular fibrillationa chaotic rhythm from the lower heart chambers22.7%129
- Abdominal distensiona bloated abdomen22.5%128
- Hyponatraemialow blood sodium21.7%123
- Appendicitis21.3%121
- Appendicolith21.1%120
- General physical health deteriorationgeneral decline in health20.6%117
- Multiple organ dysfunction syndromeseveral organs failing20.6%117
- Cardiogenic shockshock from the heart failing to pump20.4%116
- Sepsisa severe body-wide response to infection20.4%116
- Stressstress20.4%116
- Blood phosphorus increased19.9%113
- Macular degenerationa disease of the central retina18.5%105
- Condition aggravatedthe condition being treated got worse18%102
- Somnolencedrowsiness18%102
- Dry mouthdry mouth17.6%100
- Blood cholesterol increasedraised cholesterol17.1%97
- Pulmonary embolisma blood clot in the lung17.1%97
- Myasthenia gravis16.4%93
- Blood uric acid increasedraised uric acid16.2%92
- Diabetes mellitusdiabetes15.3%87
- Hyperphosphataemia15.3%87
- Incorrect route of product administrationthe product was given by the wrong route15.1%86
Top 30 of 239 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 0% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Constipation | 270 | 47.5% |
| Iron deficiency | 12 | 2.1% |
| Vomiting | 8 | 1.4% |
| Medication error | 5 | 0.9% |
| Electroconvulsive therapy | 4 | 0.7% |
| Gastrointestinal disorder | 3 | 0.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 568 reports.
In context
| Measure | Polyethylene glycol 4000 | All reports |
|---|---|---|
| Reports as suspect product | 568 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 59 | 1,332,454 |
| Marked serious | 100% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 384 | 91 |
| Hospitalisation recorded, per 1,000 reports | 537 | 213 |
| Consumer-filed share | 8.5% | 45.8% |
| Top term, share of reports | Off label use 32% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Questions about Polyethylene glycol 4000 reports
How many adverse event reports has FDA received for Polyethylene glycol 4000?
568 reports list Polyethylene glycol 4000 as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 59 of them arrived in the latest 12 months. Another 1,270 list it only as a concomitant medication.
What reactions are recorded in Polyethylene glycol 4000 reports?
off label use (32%), nausea (31.2%), constipation (29.9%), abdominal pain (28.3%) and drug ineffective (25.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Polyethylene glycol 4000 was responsible.
How serious are the reports?
100% are marked serious by the reporter. Among the outcomes recorded, 38.4% of reports include death and 53.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (47%), physician (23.6%) and pharmacist (20.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Polyethylene glycol 4000 rising?
59 reports in the 12 months to June 2026, down 50% from 119 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Polyethylene glycol 4000 was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Polyethylene glycol 4000?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Polyethylene glycol 4000 as a suspect or interacting product; reports listing it only as a concomitant medication (1,270) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.