Over-the-counter medication · Osmotic Laxative
polyethylene glycol 3350
Also sold as MiraLAX. MiraLAX treats occasional constipation, which means you have irregular bowel movements.
Data updated 2026-05-15
- 91,655
- FDA reportsOften reported
- 1
- Recall record
What the data shows
polyethylene glycol 3350 (MiraLAX) is an over-the-counter Osmotic Laxative, more reported than most tracked drugs (91,655 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
polyethylene glycol 3350 (MiraLAX) is an over-the-counter Osmotic Laxative. MiraLAX treats occasional constipation, which means you have irregular bowel movements.
MiraLAX is a laxative medicine. It helps to relieve constipation by drawing water into your stool, making it easier to pass.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.03/unit
Generic Available
Yes (16 manufacturers)
Pricing data from NADAC (CMS), effective December 25, 2024. Compare all drug costs →
What it does
MiraLAX treats occasional constipation, which means you have irregular bowel movements.
Common side effects
Diarrhea, Nausea, Headache
Key warnings
Do not use more than directed unless your doctor tells you to.
The sections below are summarized in plain English from polyethylene glycol 3350's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
MiraLAX is an osmotic laxative. It works by drawing water into your colon. This softens the stool and makes it easier to pass, relieving constipation.
How to Take It
Adults and children 17 and older should take MiraLAX once a day. Fill the bottle cap to the white section, which measures 17 grams. Mix the powder into 4 to 8 ounces of any beverage (cold, hot, or room temperature) and stir until dissolved. Drink the entire solution. Do not combine with starch-based thickeners.
This is a plain-language summary of polyethylene glycol 3350's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if MiraLAX is safe to use during pregnancy or while breastfeeding. Talk to your doctor before using this medicine if you are pregnant or breastfeeding.
This is a plain-language summary of polyethylene glycol 3350's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. Do not take more than one dose per day.
This is a plain-language summary of polyethylene glycol 3350's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store MiraLAX at room temperature between 68°F and 77°F.
Side Effects (from patient reports)
Based on 91,655 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for polyethylene glycol 3350, by number of reports
- Diarrhea
Diarrhea
6,828 reports
- Nausea
Nausea
5,306 reports
- Constipation
Constipation
5,100 reports
- Tiredness
Tiredness
4,563 reports
- Vomiting
Vomiting
3,284 reports
- Pain
Pain
2,929 reports
- Taking the medicine for the wrong amount of time
Taking the medicine for the wrong amount of time
2,837 reports
- Taking the wrong dose 2,724
Taking the wrong dose
2,724 reports
- Death 2,718
Death
2,718 reports
- Difficulty breathing 2,705
Difficulty breathing
2,705 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for polyethylene glycol 3350 each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where polyethylene glycol 3350 sits
polyethylene glycol 3350 has more FDA adverse-event reports than 84% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is polyethylene glycol 3350; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 91,655 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
91,655
Reports Mentioning Death
6,093
6.6% of reports — not proof of cause
Hospitalization Reports
20,647
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 4 | DIARRHOEA | 6,828 |
| 5 | NAUSEA | 5,306 |
| 6 | CONSTIPATION | 5,098 |
| 7 | FATIGUE | 4,564 |
| 9 | VOMITING | 3,284 |
| 10 | PAIN | 2,927 |
| 11 | INCORRECT DRUG ADMINISTRATION DURATION | 2,837 |
| 12 | INCORRECT DOSE ADMINISTERED | 2,725 |
| 13 | DEATH | 2,717 |
| 14 | DYSPNOEA | 2,703 |
| 15 | HEADACHE | 2,657 |
| 16 | ASTHENIA | 2,622 |
| 17 | DIZZINESS | 2,434 |
| 18 | ABDOMINAL PAIN | 2,419 |
| 19 | INCORRECT PRODUCT ADMINISTRATION DURATION | 2,310 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Do not use more than directed unless your doctor tells you to. Ask a doctor if you are 16 years old or younger.
Common Questions
How quickly does MiraLAX work?
Can I take MiraLAX every day?
How much MiraLAX should I take?
Can I mix MiraLAX with any drink?
What should I do if MiraLAX doesn't work?
Can children take MiraLAX?
Is it okay to use MiraLAX long term?
What if the powder has clumps?
How do I know the product is safe to use?
Can I mix MiraLAX with food?
What are the common side effects of polyethylene glycol 3350?
What drug class is polyethylene glycol 3350?
Is polyethylene glycol 3350 safe during pregnancy?
Has polyethylene glycol 3350 been recalled?
Active Recalls
CGMP Deviations: product held outside appropriate storage temperature conditions.
Family Dollar Stores, Llc.
Related Medications in Osmotic Laxative
Other drugs grouped near polyethylene glycol 3350 - same-class peers and common alternatives.
alosetron
Lotronex
Alosetron (Lotronex) is a medicine for women with severe diarrhea-predominant irritable bowel syndrome (IBS).
Compare with polyethylene glycol 3350 →
aprepitant
Emend
Aprepitant (Emend) is a medicine that helps prevent nausea and vomiting.
Compare with polyethylene glycol 3350 →
bisacodyl
Dulcolax
Bisacodyl is a medicine that helps you have a bowel movement.
Compare with polyethylene glycol 3350 →
bismuth subsalicylate
Pepto-Bismol
Bismuth subsalicylate (Pepto-Bismol) is a medicine that can treat diarrhea and upset stomach.
Compare with polyethylene glycol 3350 →
cimetidine
Tagamet
Cimetidine (Tagamet) reduces stomach acid.
Compare with polyethylene glycol 3350 →
Compare polyethylene glycol 3350 vs alosetron side-by-side →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for polyethylene glycol 3350
The FDA label for polyethylene glycol 3350 (sold under brand names such as MiraLAX) classifies it as an over-the-counter product in the Osmotic Laxative class. MiraLAX treats occasional constipation, which means you have irregular bowel movements. Official labeling lists 4 commonly reported side effects, including Diarrhea, Nausea, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 91,655 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.03.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: March 21, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages