POLYETHYLENE GLYCOL 400

N/A

Manufactured by Bausch & Lomb Incorporated

28,955 FDA adverse event reports analyzed

Last updated: 2026-04-14

About POLYETHYLENE GLYCOL 400

POLYETHYLENE GLYCOL 400 is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch & Lomb Incorporated. The most commonly reported adverse reactions for POLYETHYLENE GLYCOL 400 include DRUG INEFFECTIVE, INCORRECT PRODUCT ADMINISTRATION DURATION, OFF LABEL USE, NAUSEA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for POLYETHYLENE GLYCOL 400.

Top Adverse Reactions

DRUG INEFFECTIVE1,724 reports
INCORRECT PRODUCT ADMINISTRATION DURATION1,263 reports
OFF LABEL USE1,230 reports
NAUSEA901 reports
DIARRHOEA857 reports
CONSTIPATION662 reports
INCORRECT DRUG ADMINISTRATION DURATION625 reports
VOMITING604 reports
UNDERDOSE593 reports
ABDOMINAL PAIN571 reports
FATIGUE521 reports
HEADACHE519 reports
ABDOMINAL DISTENSION473 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION443 reports
INCORRECT DOSE ADMINISTERED413 reports
PYREXIA410 reports
DYSPNOEA409 reports
CONDITION AGGRAVATED407 reports
PAIN396 reports
DEATH378 reports
ASTHENIA371 reports
ANAEMIA361 reports
MALAISE336 reports
ABDOMINAL PAIN UPPER333 reports
DIZZINESS326 reports
WEIGHT DECREASED326 reports
HYPONATRAEMIA308 reports
PNEUMONIA299 reports
GENERAL PHYSICAL HEALTH DETERIORATION298 reports
SEPSIS298 reports
SOMNOLENCE283 reports
FALL267 reports
FLATULENCE266 reports
STRESS260 reports
HYPOTENSION248 reports
PRODUCT USE IN UNAPPROVED INDICATION243 reports
OVERDOSE242 reports
DRUG INTOLERANCE238 reports
FEBRILE NEUTROPENIA232 reports
PULMONARY EMBOLISM221 reports
FREQUENT BOWEL MOVEMENTS211 reports
EXPIRED PRODUCT ADMINISTERED208 reports
RASH207 reports
ACUTE KIDNEY INJURY203 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME203 reports
ASCITES202 reports
ABDOMINAL DISCOMFORT199 reports
CONFUSIONAL STATE196 reports
COUGH190 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS190 reports
CARDIOGENIC SHOCK188 reports
DECREASED APPETITE187 reports
DRY MOUTH187 reports
APPENDICITIS186 reports
ARTHRALGIA186 reports
HYPERSENSITIVITY186 reports
VENTRICULAR FIBRILLATION182 reports
APPENDICOLITH181 reports
THERAPEUTIC PRODUCT EFFECT DECREASED181 reports
ANXIETY179 reports
DRUG HYPERSENSITIVITY177 reports
COVID 19174 reports
INTENTIONAL PRODUCT MISUSE173 reports
PRURITUS173 reports
HYPERTENSION167 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE166 reports
BACK PAIN163 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION160 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE159 reports
URINARY TRACT INFECTION159 reports
SLEEP DISORDER158 reports
DYSPEPSIA153 reports
MACULAR DEGENERATION153 reports
NO ADVERSE EVENT152 reports
TREMOR151 reports
HAEMATOCHEZIA150 reports
DEPRESSION149 reports
PAIN IN EXTREMITY149 reports
THROMBOSIS149 reports
SWELLING148 reports
THROMBOCYTOPENIA148 reports
BLOOD PHOSPHORUS INCREASED147 reports
BLOOD PRESSURE INCREASED147 reports
ERYTHEMA147 reports
INSOMNIA143 reports
GAIT DISTURBANCE142 reports
INFUSION RELATED REACTION142 reports
NEUTROPENIA142 reports
NEURALGIA139 reports
PRODUCT DOSE OMISSION ISSUE138 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION137 reports
DEHYDRATION136 reports
DIABETES MELLITUS136 reports
BACTERIAL INFECTION135 reports
BLOOD CHOLESTEROL INCREASED135 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION132 reports
OEDEMA PERIPHERAL132 reports
RECTAL HAEMORRHAGE131 reports
DRUG EFFECT DECREASED128 reports
DYSPHONIA128 reports

Report Outcomes

Out of 11,919 classified reports for POLYETHYLENE GLYCOL 400:

Serious 52.3%Non-Serious 47.7%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female5,794 (55.6%)
Male4,622 (44.3%)
Unknown7 (0.1%)

Reports by Age

Age 80401 reports
Age 71293 reports
Age 72214 reports
Age 74191 reports
Age 76189 reports
Age 78189 reports
Age 77187 reports
Age 79186 reports
Age 66185 reports
Age 70179 reports
Age 68171 reports
Age 75167 reports
Age 65164 reports
Age 73164 reports
Age 81161 reports
Age 84155 reports
Age 69154 reports
Age 64151 reports
Age 67143 reports
Age 82134 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with POLYETHYLENE GLYCOL 400?

This profile reflects 28,955 FDA FAERS reports that mention POLYETHYLENE GLYCOL 400. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for POLYETHYLENE GLYCOL 400?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, INCORRECT PRODUCT ADMINISTRATION DURATION, OFF LABEL USE, NAUSEA, DIARRHOEA, CONSTIPATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures POLYETHYLENE GLYCOL 400?

Labeling and FAERS entries often list Bausch & Lomb Incorporated in connection with POLYETHYLENE GLYCOL 400. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.