Sold as ClearLax, Gavilax, GentleLax, HealthyLax, Miralax and 1 more.
First FDA approval 02/18/1999: 27 years on the US market.
This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
B
Score breakdown (75/100)
Safety ×35%
A
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
A
Options ×10%
C
Safety: 95
Death share in reports is near or below the FAERS average (0.7x)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 25
20 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed
No Cochrane review found (-5)
Only 44% of completed registered trials posted results (-8)
Regulatory history: 91
Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 19 generic makers (-1)
7 label changes approved since 2021: the safety story is still moving (-8)
Money & lawsuits: 100
Pharma paid doctors $0 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 70
Generic versions approved (19 applications)
No same-class alternatives found: little leverage to switch (-30)
What the FDA label says
Approved uses
Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
Contraindications
None listed.
Warnings and precautions
Warnings Allergy alert Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome Ask a doctor of pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if you have rectal bleeding or you nausea, bloating or cramping or abdominal pain gets worse. These may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Adverse reactions (label)
Not available.
Source: FDA SPL label for MiraLAX (Bayer HealthCare LLC.), effective 20260504.
Full label on DailyMed.
Side-effect reports sent to the FDA
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
81,090reports that mention this drug
81,041of those blame this drug, not another one the person was taking
39%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
6.3%of reports include a death, from any cause (average for all drugs: 9.1%)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
Recalls and regulatory record
1recall actions on file
2 / 19brand / generic applications
7label changes since 2021
NoREMS program
Date
Class
Firm
Reason
06/2022
Class II
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Evidence base
20randomized trials (PubMed)
1systematic reviews
154registered trials
44%of completed trials posted results
12%terminated or withdrawn
35%industry-funded
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
Money and lawsuits
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
Who takes it and what it costs
Not in the Medicare Part D spending file (typically hospital-administered or very new drugs).
Same-class alternatives
No same-class alternatives found in RxClass.
Questions to ask your prescriber
The most-reported problems in FDA's adverse event data are product use issue, diarrhoea. How would we recognize and handle those?
Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)