Adverse Event Profile: Vitamin B12

Source: FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System Total Events: 125 Serious Events: 41 Date Range: 20050301 to 20250831

Top Reported Reactions

DYSPNOEA: 13
CHOKING: 12
Nausea: 9
DYSPHAGIA: 8
HYPERSENSITIVITY: 7
Dizziness: 7
Diarrhoea: 7
Headache: 7
FOREIGN BODY TRAUMA: 7
NAUSEA: 6
Rash: 6
FALL: 5
ALOPECIA: 5
Alopecia: 5
VOMITING: 5
PRURITUS: 5
Foreign body: 4
HEADACHE: 4
Dyspnoea: 4
Fatigue: 4

Outcomes

Other Serious or Important Medical Event: 77
Visited a Health Care Provider: 25
Hospitalization: 20
Other Outcome: 17
Visited Emergency Room: 16
Disability: 13
Other Serious Outcome: 9
Life Threatening: 7
Death: 1
Allergic Reaction: 1

Products Involved (60 unique)

B-12
B-12 ENERGY BERRYMELT
B-12 MULTI VITIMAN
B-12 SUBLINGUAL
B-COMPLEX (B1, B2, B6,B12, FOLATE, BIOTIN, PANTOTH
B12
B12 (CYANOCOBALAMIN)
B12 (CYANOCOBALAMIN-TANNIN COMPLEX)
B12 (DIETARY SUPPLEMENT)
B12 ELITE
B12 ENERGY BERRYMELTS (DIETARY SUPPLEMENT) TABLET
B12 FOLATE
B12 complex
B12 metabolism support supplement
B12-VITAMIN (CYANOCOBALAMIN)
CARE OF PROBIOTIC (BIFIDOBACTERIUM LACTIS BB-12,
CVS HEALTH B-12 1000MCG TIMED TABLET
CYANOCOBALAMIN
GNC LIQUID VITAMIN B-12 IN A PLASTIC DROPPER BOTTL
Hydroxy-B12

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.