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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.

BETA CAROTENE: 119 Adverse Event Reports & Safety Profile

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119
Total FAERS Reports
89 (74.8%)
Deaths Reported
85
Hospitalizations
119
As Primary/Secondary Suspect
59
Life-Threatening
74
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status

FDA Application: 017589 ·

First Report: 20200101 · Latest Report: 20210605

What Are the Most Common BETA CAROTENE Side Effects?

#1 Most Reported
Hyponatraemia
99 reports (83.2%)
#2 Most Reported
Stress
89 reports (74.8%)
#3 Most Reported
Multiple organ dysfunction syndrome
84 reports (70.6%)

All BETA CAROTENE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hyponatraemia 99 83.2% 83 79
Stress 89 74.8% 83 63
General physical health deterioration 84 70.6% 84 64
Multiple organ dysfunction syndrome 84 70.6% 84 64
Sepsis 81 68.1% 81 61
Off label use 80 67.2% 80 64
Vomiting 79 66.4% 71 53
Nausea 78 65.6% 70 51
Condition aggravated 75 63.0% 75 64
Cardiogenic shock 74 62.2% 74 55
Ventricular fibrillation 74 62.2% 74 55
Abdominal distension 73 61.3% 73 54
Somnolence 73 61.3% 73 62
Abdominal pain 72 60.5% 72 53
Appendicitis 72 60.5% 72 53
Ascites 72 60.5% 72 53
Constipation 72 60.5% 72 53
Appendicolith 71 59.7% 71 52
Anaemia 67 56.3% 59 55
Myasthenia gravis 65 54.6% 65 62

Who Reports BETA CAROTENE Side Effects? Age & Gender Data

Gender: 9.2% female, 90.8% male. Average age: 76.5 years. Most reports from: CA. View detailed demographics →

Is BETA CAROTENE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2020 17 12 12
2021 14 1 14

View full timeline →

What Is BETA CAROTENE Used For?

IndicationReports
Nutritional supplementation 56
Product used for unknown indication 49
Supplementation therapy 15
Anaemia 8
Cystic fibrosis 5

BETA CAROTENE vs Alternatives: Which Is Safer?

BETA CAROTENE vs BETA GLUCAN BETA CAROTENE vs BETAHISTINE BETA CAROTENE vs BETAINE BETA CAROTENE vs BETAMETHASONE BETA CAROTENE vs BETAMETHASONE DIPROPIONATE BETA CAROTENE vs BETAMETHASONE DIPROPIONATE\BETAMETHASONE BETA CAROTENE vs BETAMETHASONE DIPROPIONATE\CALCIPOTRIENE BETA CAROTENE vs BETAMETHASONE DIPROPIONATE\CALCIPOTRIENE HYDRATE BETA CAROTENE vs BETAMETHASONE DIPROPIONATE\CALCIPOTRIENE\CALCIPOTRIENE HYDRATE BETA CAROTENE vs BETAMETHASONE DIPROPIONATE\CLOTRIMAZOLE

Official FDA Label for BETA CAROTENE

Official prescribing information from the FDA-approved drug label.