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 →
NADAC price trail: POLYETHYLENE GLYCOL 3350 POWD
Same CMS presentation as the headline generic unit price above (3 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -95% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| October 23, 2024 | $1.17/EA | - | 4 |
| December 18, 2024 | $0.5827/GM | -50.2% | 33 |
| December 25, 2024 | $0.0291/GM | -95% | 1 |
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.
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
- Diarrhoea
Diarrhoea
6,828 reports
- Nausea
Nausea
5,306 reports
- Constipation
Constipation
5,098 reports
- Fatigue
Fatigue
4,564 reports
- Vomiting
Vomiting
3,284 reports
- Pain
Pain
2,927 reports
- Incorrect Drug Administration Duration
Incorrect Drug Administration Duration
2,837 reports
- Incorrect Dose Administered 2,725
Incorrect Dose Administered
2,725 reports
- Death 2,717
Death
2,717 reports
- Dyspnoea 2,703
Dyspnoea
2,703 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) 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?
What pregnancy or breastfeeding source fields are listed for polyethylene glycol 3350?
Has polyethylene glycol 3350 been recalled?
Active Recalls
CGMP Deviations: product held outside appropriate storage temperature conditions.
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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 →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for polyethylene glycol 3350: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 91,655.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 6.65%.
- ketoconazole Δ 0.00 pts · 16,231 reports · Azole Antifungal 6.65%death share
- dronedarone Δ 0.00 pts · 9,899 reports · Class III Antiarrhythmic 6.65%death share
- cefixime Δ 0.01 pts · 2,824 reports · Third-Generation Cephalosporin 6.66%death share
- ibuprofen Δ 0.02 pts · 262,453 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 6.66%death share
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: March 21, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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