INSTALAX POLYETHYLENE GLYCOL 3350

N/A

Manufactured by ANI Pharmaceuticals, Inc.

28,632 FDA adverse event reports analyzed

Last updated: 2026-04-14

About INSTALAX POLYETHYLENE GLYCOL 3350

INSTALAX POLYETHYLENE GLYCOL 3350 is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for INSTALAX POLYETHYLENE GLYCOL 3350 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 INSTALAX POLYETHYLENE GLYCOL 3350.

Top Adverse Reactions

DRUG INEFFECTIVE1,703 reports
INCORRECT PRODUCT ADMINISTRATION DURATION1,263 reports
OFF LABEL USE1,225 reports
NAUSEA894 reports
DIARRHOEA849 reports
CONSTIPATION654 reports
INCORRECT DRUG ADMINISTRATION DURATION625 reports
VOMITING601 reports
UNDERDOSE593 reports
ABDOMINAL PAIN568 reports
FATIGUE507 reports
HEADACHE493 reports
ABDOMINAL DISTENSION470 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION436 reports
INCORRECT DOSE ADMINISTERED411 reports
PYREXIA406 reports
DYSPNOEA404 reports
CONDITION AGGRAVATED402 reports
PAIN384 reports
DEATH372 reports
ASTHENIA367 reports
ANAEMIA361 reports
MALAISE334 reports
ABDOMINAL PAIN UPPER327 reports
WEIGHT DECREASED321 reports
DIZZINESS314 reports
HYPONATRAEMIA308 reports
GENERAL PHYSICAL HEALTH DETERIORATION298 reports
SEPSIS298 reports
PNEUMONIA296 reports
SOMNOLENCE281 reports
FLATULENCE265 reports
FALL261 reports
STRESS258 reports
HYPOTENSION246 reports
OVERDOSE241 reports
PRODUCT USE IN UNAPPROVED INDICATION241 reports
DRUG INTOLERANCE237 reports
FEBRILE NEUTROPENIA232 reports
PULMONARY EMBOLISM221 reports
FREQUENT BOWEL MOVEMENTS210 reports
EXPIRED PRODUCT ADMINISTERED207 reports
ACUTE KIDNEY INJURY203 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME203 reports
ASCITES202 reports
RASH199 reports
CONFUSIONAL STATE195 reports
ABDOMINAL DISCOMFORT192 reports
CARDIOGENIC SHOCK188 reports
DRY MOUTH187 reports
APPENDICITIS186 reports
DECREASED APPETITE186 reports
COUGH183 reports
VENTRICULAR FIBRILLATION182 reports
APPENDICOLITH181 reports
THERAPEUTIC PRODUCT EFFECT DECREASED181 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS181 reports
ANXIETY176 reports
ARTHRALGIA175 reports
HYPERSENSITIVITY175 reports
DRUG HYPERSENSITIVITY174 reports
COVID 19172 reports
INTENTIONAL PRODUCT MISUSE170 reports
HYPERTENSION167 reports
PRURITUS164 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE164 reports
BACK PAIN159 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE159 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION158 reports
SLEEP DISORDER156 reports
URINARY TRACT INFECTION154 reports
MACULAR DEGENERATION152 reports
NO ADVERSE EVENT151 reports
DYSPEPSIA150 reports
TREMOR150 reports
HAEMATOCHEZIA149 reports
THROMBOSIS149 reports
DEPRESSION148 reports
SWELLING148 reports
THROMBOCYTOPENIA148 reports
BLOOD PHOSPHORUS INCREASED147 reports
BLOOD PRESSURE INCREASED146 reports
ERYTHEMA145 reports
PAIN IN EXTREMITY144 reports
NEUTROPENIA142 reports
INFUSION RELATED REACTION140 reports
NEURALGIA139 reports
GAIT DISTURBANCE137 reports
DEHYDRATION136 reports
DIABETES MELLITUS136 reports
INSOMNIA136 reports
BACTERIAL INFECTION135 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION135 reports
BLOOD CHOLESTEROL INCREASED134 reports
PRODUCT DOSE OMISSION ISSUE133 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION132 reports
RECTAL HAEMORRHAGE131 reports
OEDEMA PERIPHERAL130 reports
DRUG EFFECT DECREASED127 reports
MYASTHENIA GRAVIS126 reports

Report Outcomes

Out of 11,677 classified reports for INSTALAX POLYETHYLENE GLYCOL 3350:

Serious 52.5%Non-Serious 47.5%

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

Female5,621 (55.1%)
Male4,567 (44.8%)
Unknown5 (0.0%)

Reports by Age

Age 80398 reports
Age 71288 reports
Age 72211 reports
Age 74187 reports
Age 76187 reports
Age 77186 reports
Age 79185 reports
Age 78180 reports
Age 66178 reports
Age 70176 reports
Age 68166 reports
Age 75163 reports
Age 65162 reports
Age 73162 reports
Age 81157 reports
Age 84152 reports
Age 69151 reports
Age 64146 reports
Age 67140 reports
Age 83134 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 INSTALAX POLYETHYLENE GLYCOL 3350?

This profile reflects 28,632 FDA FAERS reports that mention INSTALAX POLYETHYLENE GLYCOL 3350. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for INSTALAX POLYETHYLENE GLYCOL 3350?

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 INSTALAX POLYETHYLENE GLYCOL 3350?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with INSTALAX POLYETHYLENE GLYCOL 3350. 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.