POLYETHYLENE GLYCOL\POTASSIUM\SODIUM BICARBONATE\SODIUM: 120 Adverse Event Reports & Safety Profile

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120

Total FAERS Reports

6 (5.0%)

Deaths Reported

Hospitalizations

120

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Active Ingredient: POLYETHYLENE GLYCOL\POTASSIUM CHLORIDE\SODIUM BICARBONATE\SODIUM CHLORIDE ·

First Report: 2010 · Latest Report: 20230201

What Are the Most Common POLYETHYLENE GLYCOL\POTASSIUM\SODIUM BICARBONATE\SODIUM Side Effects?

#1 Most Reported

Macular degeneration

100 reports (83.3%)

#2 Most Reported

Drug ineffective

100 reports (83.3%)

#3 Most Reported

Off label use

54 reports (45.0%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Drug ineffective	100	83.3%	0	49
Macular degeneration	100	83.3%	0	50
Off label use	54	45.0%	3	50
Nausea	53	44.2%	3	49
Malaise	52	43.3%	0	50
Pain	52	43.3%	0	49
Therapeutic product effect incomplete	51	42.5%	0	49
Chronic sinusitis	50	41.7%	0	48
Constipation	50	41.7%	3	47
Pyrexia	50	41.7%	0	48
Weight decreased	50	41.7%	0	48
Abdominal pain	49	40.8%	3	47
Paraesthesia oral	49	40.8%	0	47
Anaemia	48	40.0%	2	46
Erythema	48	40.0%	0	46
Colitis	46	38.3%	0	46
Female genital tract fistula	46	38.3%	0	46
Frequent bowel movements	46	38.3%	0	46
Headache	46	38.3%	0	45
Haematochezia	45	37.5%	0	45

Gender: 85.5% female, 14.5% male. Average age: 67.1 years. Most reports from: CA. View detailed demographics →

Year	Reports	Deaths	Hosp.
2010	1	0	0
2015	2	2	0
2018	4	0	4
2020	1	1	0
2021	2	0	2
2022	2	0	0
2023	1	0	0

Indication	Reports
Product used for unknown indication	98
Constipation	9

Official prescribing information from the FDA-approved drug label.