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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM: 1,961 Adverse Event Reports & Safety Profile

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1,961
Total FAERS Reports
145 (7.4%)
Deaths Reported
507
Hospitalizations
1,961
As Primary/Secondary Suspect
167
Life-Threatening
112
Disabilities

Active Ingredient: ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM CHLORIDE\SODIUM ASCORBATE\SODIUM CHLORIDE\SODIUM SULFATE ·

First Report: 2008 · Latest Report: 20250902

What Are the Most Common ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM Side Effects?

#1 Most Reported
Vomiting
524 reports (26.7%)
#2 Most Reported
Nausea
424 reports (21.6%)
#3 Most Reported
Drug ineffective
268 reports (13.7%)

All ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Vomiting 524 26.7% 72 150
Nausea 424 21.6% 56 131
Drug ineffective 268 13.7% 45 100
Abdominal pain 191 9.7% 54 90
Headache 168 8.6% 16 61
Abdominal distension 144 7.3% 60 50
Diarrhoea 143 7.3% 8 34
Product taste abnormal 139 7.1% 0 2
Hyponatraemia 135 6.9% 61 107
Dehydration 129 6.6% 2 44
Malaise 125 6.4% 0 51
Off label use 124 6.3% 61 85
Pyrexia 117 6.0% 18 93
Constipation 108 5.5% 52 68
Dyspnoea 108 5.5% 35 60
Pain 99 5.1% 18 63
Dizziness 95 4.8% 0 22
Chills 88 4.5% 1 18
Anaemia 83 4.2% 46 81
Asthenia 80 4.1% 16 29

Who Reports ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM Side Effects? Age & Gender Data

Gender: 57.2% female, 42.8% male. Average age: 66.6 years. Most reports from: US. View detailed demographics →

Is ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 2 0 1
2010 1 0 0
2011 2 0 0
2012 3 0 0
2013 9 0 4
2014 70 4 11
2015 123 8 31
2016 139 8 37
2017 107 5 43
2018 116 3 37
2019 134 2 35
2020 148 26 41
2021 115 7 26
2022 103 2 28
2023 78 6 18
2024 105 2 33
2025 43 0 9

View full timeline →

What Is ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM Used For?

IndicationReports
Bowel preparation 1,151
Product used for unknown indication 327
Colonoscopy 281
Constipation 73
Endoscopy large bowel 58
Ill-defined disorder 22
Off label use 15
Iron deficiency 12
Nutritional supplementation 7
Preoperative care 5

ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM vs Alternatives: Which Is Safer?

ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM vs ASENAPINE ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM vs ASFOTASE ALFA ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM vs ASIAN GINSENG ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM vs ASMANEX TWISTHALER ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM vs ASPARAGINASE ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM vs ASPARAGINASE ERWINIA CHRYSANTHEMI ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM vs ASPARAGINASE ERWINIA CHRYSANTHEMI -RYWN ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM vs ASPIRIN ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM vs ASPIRIN DL-LYSINE ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM vs ASPIRIN LYSINE

Official FDA Label for ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM

Official prescribing information from the FDA-approved drug label.