Adverse Event Profile: Niacin

Source: FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System Total Events: 27 Serious Events: 8 Date Range: 20041203 to 20250307

Top Reported Reactions

Hypersensitivity: 4
Burning sensation: 3
Rash: 3
PRURITUS: 3
RASH: 3
ERYTHEMA: 3
DECREASED APPETITE: 2
Nausea: 2
Erythema: 2
Swelling: 2
HYPERSENSITIVITY: 2
CHROMATURIA: 2
URTICARIA: 2
BURNING SENSATION: 2
Dizziness: 2
Asthenia: 2
Catatonia: 2
Skin burning sensation: 2
VIIth nerve paralysis: 2
DEHYDRATION: 1

Outcomes

Other Serious or Important Medical Event: 16
Other Serious Outcome: 8
Visited a Health Care Provider: 5
Hospitalization: 4
Visited Emergency Room: 3
Other Outcome: 3
Disability: 2
Life Threatening: 2
Allergic Reaction: 1

Products Involved (18 unique)

FLUSH FREE NIACIN
FLUSH-FREE NIACIN (INOSITOL HEXANIACINATE)
GNC NIACIN
IMMEDIATE RELEASE PAIN NIACIN
Immediate Release Plain Niacin Endurance Products
NIACIN
NIACIN (NICOTINIC ACID [NOICOTINIC ACID])
NIACIN 500 NON-FLUSH
NIACINAMIDE
NICOTINIC ACID
Niacin
PIPINGROCK NIACIN
PURITAN'S PRIDE NIACIN
PURITANS PRIDE NIACIN
SOLGAR NIACIN (VITAMIN B3)
SOLGAR NIACIN VITAMIN B3
SUNDOWN NATURALS NIACIN
niacin

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.