MiraLAX: adverse event reports filed with FDA

38,188

reports as suspect product

0.2% of all reports · about 1,704 a year

1,721

reports, 12 months to June 2026

1,398 in the 12 months before

7.2%

marked serious by the reporter

54.5% across the class

0.4%

record death among outcomes, as reported

152 reports · not verified by FDA

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 MiraLAX reports recording the termmedian drug in osmotic laxative

1. Product use issuea problem in how the product was used24.7%9,432
2. Drug ineffectivethe medicine did not work as expected16.1%6,143
3. Off label useused for a purpose or in a way not on the label14.8%5,657
4. Diarrhoealoose or frequent stools8.5%3,241
5. Product use in unapproved indicationused for a purpose not on the label7.9%3,013
6. Incorrect drug administration duration5.7%2,166
7. Incorrect dose administeredthe wrong dose was given5.3%2,042
8. Product prescribing issue4.8%1,845
9. Expired product administeredthe product was used past its expiry date4%1,524
10. Circumstance or information capable of leading to medication errora situation that could lead to a medication error3.5%1,354
11. Flatulencewind3.3%1,255
12. Wrong technique in product usage processthe product was used in the wrong way3%1,148
13. Incorrect product administration duration2.8%1,053
14. Constipationconstipation2.7%1,027
15. Underdoseless than the intended dose2.6%1,009
16. Abdominal distensiona bloated abdomen2.6%988
17. Drug administered to patient of inappropriate age2.5%973
18. Nauseafeeling sick2.5%943
19. Abdominal pain upperupper stomach pain2.2%838
20. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times2%767
21. Product taste abnormalthe product tasted odd1.7%659
22. Drug prescribing errora prescribing mistake1.7%656
23. Frequent bowel movements1.7%650
24. Extra dose administered1.7%637
25. Overdosea dose above the recommended amount1.6%627
26. Vomitingbeing sick1.4%544
27. Muscle spasmsmuscle cramps1.3%499
28. Abdominal discomfortstomach discomfort1.2%474
29. Inappropriate prescribing1.2%466
30. Abdominal painstomach or belly pain1.2%465

Top 30 of 965 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 median share across the 17 drugs in the osmotic laxative class; 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 129,514 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 38,188 reports.

Drugs most often listed in the same reports

Other products listed in reports where MiraLAX is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

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."

Other drugs in the osmotic laxative class

Ordered by report count for navigation only. 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." A brand and its generic are separate rows because reporters name them separately.

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 MiraLAX as a suspect or interacting product; reports listing it only as a concomitant medication (40,404) 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.