LUTEIN: 100 Adverse Event Reports & Safety Profile

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100

Total FAERS Reports

90 (90.0%)

Deaths Reported

Hospitalizations

100

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 20060101 · Latest Report: 20220419

What Are the Most Common LUTEIN Side Effects?

#1 Most Reported

Abdominal distension

65 reports (65.0%)

#2 Most Reported

Vomiting

63 reports (63.0%)

#3 Most Reported

Hyponatraemia

63 reports (63.0%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Abdominal distension	65	65.0%	65	45
Appendicitis	63	63.0%	63	43
Ascites	63	63.0%	63	43
Hyponatraemia	63	63.0%	63	43
Vomiting	63	63.0%	63	43
Abdominal pain	62	62.0%	62	42
Appendicolith	62	62.0%	62	42
Ventricular fibrillation	62	62.0%	62	42
General physical health deterioration	61	61.0%	61	41
Stress	61	61.0%	61	41
Constipation	60	60.0%	60	40
Multiple organ dysfunction syndrome	60	60.0%	60	40
Nausea	60	60.0%	60	40
Cardiogenic shock	59	59.0%	59	39
Off label use	59	59.0%	59	42
Sepsis	58	58.0%	58	38
Blood phosphorus increased	57	57.0%	57	40
Condition aggravated	55	55.0%	55	40
Somnolence	54	54.0%	54	40
Dry mouth	53	53.0%	53	38

Gender: 5.3% female, 94.7% male. Average age: 79.9 years. Most reports from: CA. View detailed demographics →

Year	Reports	Deaths	Hosp.
2006	1	0	0
2019	2	0	1
2020	39	39	34
2021	10	10	1
2022	1	0	1

Indication	Reports
Nutritional supplementation	71
Off label use	35
Intentional product misuse	34
Product used for unknown indication	28

Official prescribing information from the FDA-approved drug label.