Adverse Event Profile: Biotin

Source: FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System Total Events: 76 Serious Events: 17 Date Range: 20080325 to 20250519

Top Reported Reactions

Alopecia: 7
ALOPECIA: 6
Diarrhoea: 4
Nausea: 4
CHOKING: 4
Urticaria: 4
NAUSEA: 3
FATIGUE: 3
SWOLLEN TONGUE: 3
MALAISE: 3
Dehydration: 3
Dyspnoea: 3
Diarrhoea haemorrhagic: 3
DYSPNOEA: 3
Rash: 3
Blood pressure increased: 3
LOSS OF CONSCIOUSNESS: 2
ABDOMINAL PAIN: 2
HEADACHE: 2
COLON INJURY: 2

Outcomes

Other Serious or Important Medical Event: 51
Visited a Health Care Provider: 21
Hospitalization: 12
Other Outcome: 11
Other Serious Outcome: 9
Visited Emergency Room: 6
Life Threatening: 3
Disability: 2
Required Intervention: 1

Products Involved (25 unique)

BIOTIN
BIOTIN VITAMIN SUPPLEMENT
Biotin
Biotin Vitamin
DHT Blocker with Biotin vitamin
EXTRA STRENGTH HAIR, SKIN, & NAILS WITH BIOTIN
GNC PRO PERFORMANCE AMP WOMENS RIPPED VITAPAK PROG
JARROW FORMULAS BIOTIN
Multivitamin for women Collegen Biotin
NATURE BOUNTY ULTRA STRENGTH BIOTIN1000 MCG
NATURE'S BOUNTY BIOTIN
NATURE'S BOUNTY HAIR SKIN AND NAILS 5000 MCG OF BI
NATURE'S BOUNTY HAIR, SKIN & NAILS 5000 MCG BIOTIN
NATURE'S BOUNTY HAIR, SKIN & NAILS WITH BIOTIN
NATURE'S BOUNTY HAIR, SKIN AND NAILS 2500 MCG BIOT
NATUREMADE BIOTIN
NATURES BOUNTY BIOTIN 5000 RAPID RELEASE LIQUID SO
PURITAN'S PRIDE BIOTIN
PURITAN'S PRIDE ULTRA MEGA BIOTIN 10,000MCG RAPID
PURITANS PRIDE BIOTIN 10000 MCG PRODUCT

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.