Miralaxpolyethylene glycol
According to the FDA label: Uses relieves dryness of the eye. for the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to the wind and sun. may be used as a protectant against further irritation.
88,434 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Miralax in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Product Use Issue 9,866 reports
A general report that there was some problem in how the medication was used.
Full definition in the glossary →Drug Ineffective 9,436 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Off Label Use 8,859 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Diarrhoea 6,601 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Nausea 4,983 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Constipation 4,787 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →Fatigue 4,289 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Product Use in Unapproved Indication 3,636 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Vomiting 3,024 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Incorrect Drug Administration Duration 2,828 reports
A report that a medication was taken for a longer or shorter time than directed. This is a usage category.
Full definition in the glossary →Incorrect Dose Administered 2,717 reports
A report that the wrong dose was given or taken. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Pain 2,701 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Death 2,576 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Headache 2,518 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 2,484 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 48,345 |
| Male | 31,415 |
| Unknown | 251 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 5,477 |
| 18-34 | 2,637 |
| 35-49 | 3,551 |
| 50-64 | 9,480 |
| 65-74 | 11,307 |
| 75+ | 17,077 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Miralax. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 54,062 |
| Other Serious | 20,202 |
| Hospitalization | 19,125 |
| Death | 5,562 |
| Life-Threatening | 1,750 |
| Disability | 1,453 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Miralax. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 1 |
| 2004 | 203 |
| 2005 | 247 |
| 2006 | 305 |
| 2007 | 327 |
| 2008 | 496 |
| 2009 | 624 |
| 2010 | 759 |
| 2011 | 958 |
| 2012 | 2,207 |
| 2013 | 4,115 |
| 2014 | 4,034 |
| 2015 | 6,832 |
| 2016 | 8,844 |
| 2017 | 8,276 |
| 2018 | 7,658 |
| 2019 | 6,757 |
| 2020 | 6,681 |
| 2021 | 6,002 |
| 2022 | 5,615 |
| 2023 | 5,156 |
| 2024 | 5,041 |
| 2025 | 6,021 |
| 2026 (partial) | 1,275 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Miralax
In FDA adverse event reports that mention Miralax, these medications appeared most often in the same report.
- Acetaminophen (12,547 reports)
- Ergocalciferol (12,110 reports)
- Instalax Polyethylene Glycol (12,018 reports)
- Aspirin (10,420 reports)
- Omeprazole (9,211 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026