Adverse Event Profile: Probiotics

Source: FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System Total Events: 136 Serious Events: 55 Date Range: 20040526 to 20250923

Top Reported Reactions

  • Diarrhoea: 15
  • Nausea: 12
  • Vomiting: 10
  • Dyspnoea: 9
  • Pruritus: 9
  • Alopecia: 9
  • Dizziness: 8
  • HYPERSENSITIVITY: 7
  • Hypersensitivity: 6
  • Abdominal pain upper: 6
  • DIARRHOEA: 6
  • Pyrexia: 5
  • VOMITING: 5
  • Abdominal pain: 5
  • PAIN: 5
  • Dehydration: 4
  • Hospitalisation: 4
  • Pain: 4
  • Chills: 4
  • Malaise: 4

Outcomes

  • Other Serious or Important Medical Event: 81
  • Hospitalization: 34
  • Visited a Health Care Provider: 33
  • Visited Emergency Room: 23
  • Other Serious Outcome: 17
  • Life Threatening: 10
  • Disability: 10
  • Other Outcome: 9
  • Required Intervention: 3
  • Allergic Reaction: 1

Products Involved (86 unique)

  • 60 BILLION PROBIOTIC
  • ANCIENT PROBIOTICS IMMUNE 50 BILLION CFU
  • ARBONNE BIOTIC STICKS PROBIOTIC MIXED BERRY FLAVOR
  • BIFIDOBACTERIUM
  • CULTURELLE (LACTOBACILLUS RHAMNISUS
  • CULTURELLE DIGESTIVE DAILY PROBIOTIC
  • CULTURELLE LACTOBACILLUS RHAMNOSUS GG
  • CULTURELLE PROBIOTIC DIGESTIVE DAILY PROBIOTIC
  • CVS Daily Digestive Probiotics
  • DIGESTIVE ADVANTAGE DAILY PROBIOTIC GUMMIES
  • DR. NATURA FLORA PROTECT PROBIOTICS
  • DS 01 DAILY PREBIOTIC PLUS PROBIOTIC SUPPLEMENT
  • DS 01 DAILY PROBIOTIC PLUS PREBIOTIC SUPPLEMENT
  • Daily Probiotic
  • Daily Probiotic, 25 Billion CFU
  • FLORASTOR DAILY PROBIOTIC SUPPLEMENT
  • FLORASTOR KIDS PROBIOTIC SUPPLEMENT
  • FLORASTOR PROBIOTIC SUPPLEMENT
  • Florassist probiotic
  • GENESISTODAY PLANT-BASED PROBIOTIC DIETARY SUPPLEM

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.