Drug side effects
polyethylene glycol 3350 Side Effects
The reactions most often reported to the FDA for polyethylene glycol 3350 (also sold as MiraLAX), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 91,655
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2002 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of polyethylene glycol 3350 come from 91,655 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 91,655 reports to the FDA Adverse Event Reporting System (FAERS) for polyethylene glycol 3350 (MiraLAX): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
91,655
Reports Mentioning Death
6,093
6.6% of reports — not proof the medicine caused the death
Hospitalizations
20,647
22.5% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 6,093 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 2,711 |
| NAUSEA | 525 |
| SEPSIS | 477 |
| CONSTIPATION | 461 |
| VOMITING | 434 |
| PNEUMONIA | 421 |
| DYSPNOEA | 420 |
| ANAEMIA | 380 |
| FATIGUE | 360 |
| ABDOMINAL PAIN | 355 |
| ASTHENIA | 352 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 303 |
| RESPIRATORY FAILURE | 277 |
| ABDOMINAL DISTENSION | 269 |
| FALL | 268 |
| ASCITES | 262 |
| CARDIAC ARREST | 262 |
| HYPONATRAEMIA | 262 |
| PAIN | 259 |
Reactions in Hospitalization Reports
Top reactions in 20,647 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| NAUSEA | 1,945 |
| PNEUMONIA | 1,756 |
| CONSTIPATION | 1,672 |
| FATIGUE | 1,571 |
| VOMITING | 1,571 |
| DYSPNOEA | 1,507 |
| FALL | 1,423 |
| DIARRHOEA | 1,373 |
| ASTHENIA | 1,326 |
| PAIN | 1,275 |
| PYREXIA | 1,268 |
| ABDOMINAL PAIN | 1,188 |
| URINARY TRACT INFECTION | 1,091 |
| ANAEMIA | 1,084 |
| DEHYDRATION | 1,000 |
| WEIGHT DECREASED | 924 |
| HEADACHE | 848 |
| SEPSIS | 812 |
| DIZZINESS | 811 |
Nearby, Related Medications
What the FAERS Data Reveals About polyethylene glycol 3350 Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 91,655 voluntary reports linked to polyethylene glycol 3350 and its brand equivalents (MiraLAX), spanning 2002 through 2025. Of those, 6,093 (6.6%) listed death as an outcome and 20,647 (22.5%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 61% were female and 39% male; age distribution skews toward 75+, with 17,576 reports in that bracket. The single most reported reaction is diarrhoea with 6,828 submissions, followed by nausea and constipation.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to polyethylene glycol 3350's 91,655.
Read our methodology - how this data is sourced, computed, and verified.