Adverse Event Profile: Vitamin D

Source: FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System Total Events: 606 Serious Events: 168 Date Range: 20070810 to 20250922

Top Reported Reactions

CHOKING: 107
Diarrhoea: 38
DYSPHAGIA: 37
Nausea: 35
DYSPNOEA: 31
HYPERSENSITIVITY: 29
Vomiting: 28
FOREIGN BODY TRAUMA: 25
DIARRHOEA: 22
VOMITING: 22
NAUSEA: 21
Choking: 19
Alopecia: 18
Dizziness: 17
Pruritus: 17
Fatigue: 16
Malaise: 16
COUGH: 16
MALAISE: 16
ABDOMINAL PAIN: 15

Outcomes

Other Serious or Important Medical Event: 463
Visited a Health Care Provider: 92
Hospitalization: 88
Visited Emergency Room: 56
Other Serious Outcome: 55
Life Threatening: 38
Disability: 36
Other Outcome: 35
Required Intervention: 6
Death: 5

Products Involved (260 unique)

BAYER PRO ULTRA OMEGA-3 (OMEGA-3 FATTY ACIDS, VITA
CALCIUM 600 MG VITAMIN D 400 IU TABLET
CALCIUM 600MG W VIT D 800 IU 9T1AB (VITAMIN D NOS
CALCIUM 600MG W VIT D 8009T1AB (VITAMIN D NOS 800
CALCIUM AND VITAMIN D
CALCIUM AND VITAMIN D3 CALCIUM CARBONATE CHOLECALC
CALCIUM CARBONATE, CHOLECALCIFEROL
CALCIUM CARBONATE, CHOLECALCIFEROL (CALCIUM CARBON
CALCIUM CITRATE MAGNESIUM AND ZINC WITH VITAMIN D3
CALCIUM W D3 AND K
CALCIUM WITH D3
CALCIUM WITH VITAMIN D
CALCIUM WITH VITAMIN D AND IRON
CALCIUM WITH VITAMIN D NOS
CALCIUM WITH VITAMIN D3
CALCIUM+ VITAMIN D
CALTRATE 600 + VITAMIN D (CALCIUM CARBONATE, CHOL
CALTRATE 600 + VITAMIN D CALCIUM CARBONATE, CHOLE
CALTRATE D CALCIUM CARBONATE CHOLECALCIFEROL
CALTRATE (CALCIUM CARBONATE, CHOLECALCIFEROL) EFFE

Disclaimer

This data is from the FDA CAERS database. A report does not mean the supplement caused the adverse event. Reports may be incomplete, duplicated, or unrelated. This is for safety awareness only.