Adverse Event Profile: Folate

Source: FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System Total Events: 36 Serious Events: 17 Date Range: 20040402 to 20250122

Top Reported Reactions

  • NAUSEA: 7
  • CHOKING: 4
  • PYREXIA: 3
  • DIZZINESS: 3
  • DEHYDRATION: 2
  • FALL: 2
  • HYPOTENSION: 2
  • LOSS OF CONSCIOUSNESS: 2
  • Dizziness: 2
  • Abdominal pain: 2
  • DYSPHAGIA: 2
  • PRURITUS: 2
  • Blood pressure increased: 2
  • AMNESIA: 2
  • FATIGUE: 2
  • HEADACHE: 2
  • CONDITION AGGRAVATED: 2
  • DIARRHOEA: 2
  • VOMITING: 2
  • DYSPNOEA: 2

Outcomes

  • Other Serious or Important Medical Event: 24
  • Hospitalization: 10
  • Visited a Health Care Provider: 10
  • Other Serious Outcome: 7
  • Visited Emergency Room: 5
  • Disability: 4
  • Life Threatening: 3
  • Other Outcome: 2
  • Allergic Reaction: 1
  • Required Intervention: 1

Products Involved (17 unique)

  • ACIDO FOLICO FOLIC ACID
  • CVS HEALTH FOLIC ACID
  • CVS PHARMACY CHEWABLE FOLIC ACID
  • FOLATE
  • FOLIC ACID
  • FOLIC ACID (FOLIC ACID)
  • FOLIC ACID 800 MCG
  • FOLIC ACID 800 MCG TABLETS (DIETARY SUPPLEMENT) TA
  • Folate
  • Folic Acid
  • Folic acid
  • L METHYLFOLATE
  • NATURE MADE SUPER VITAMIN B COMPLEX WITH C AND FOL
  • PURITAN'S PRIDE FOLIC ACID 800 MCG TABS
  • VITAMIN WORLD FOLIC ACID 800MCG
  • folic acid
  • methyfolate

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.