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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

BIOTIN: 695 Adverse Event Reports & Safety Profile

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695
Total FAERS Reports
141 (20.3%)
Deaths Reported
229
Hospitalizations
695
As Primary/Secondary Suspect
106
Life-Threatening
111
Disabilities
Guangzhou Borderless Techno...
Manufacturer

Route: TOPICAL · Manufacturer: Guangzhou Borderless Technology Co., Ltd. · HUMAN OTC DRUG · FDA Label: Available

First Report: 1999 · Latest Report: 20250401

What Are the Most Common BIOTIN Side Effects?

#1 Most Reported
Dyspnoea
174 reports (25.0%)
#2 Most Reported
Off label use
133 reports (19.1%)
#3 Most Reported
Somnolence
130 reports (18.7%)

All BIOTIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 174 25.0% 56 58
Off label use 133 19.1% 83 93
Somnolence 130 18.7% 75 116
Cough 126 18.1% 4 7
Coronary artery disease 125 18.0% 16 15
Wheezing 119 17.1% 5 5
Muscle spasms 118 17.0% 0 0
Obstructive airways disorder 115 16.6% 5 5
Chest discomfort 114 16.4% 0 1
Abdominal distension 112 16.1% 84 72
Atrial fibrillation 112 16.1% 0 1
Cardiac disorder 111 16.0% 0 1
Dysphonia 111 16.0% 0 2
Dyspnoea exertional 111 16.0% 0 1
Eosinophilia 110 15.8% 0 0
Myoglobin blood increased 110 15.8% 0 0
Nasopharyngitis 110 15.8% 0 1
Brain natriuretic peptide increased 109 15.7% 0 0
Fractional exhaled nitric oxide increased 109 15.7% 0 0
Sensation of foreign body 107 15.4% 0 0

Who Reports BIOTIN Side Effects? Age & Gender Data

Gender: 32.5% female, 67.5% male. Average age: 67.4 years. Most reports from: CA. View detailed demographics →

Is BIOTIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 1
2006 1 0 0
2009 2 0 0
2012 2 0 0
2013 5 0 0
2014 13 0 2
2015 13 0 2
2016 15 0 3
2017 25 4 9
2018 116 0 7
2019 13 0 6
2020 90 37 38
2021 18 8 5
2022 10 0 0
2024 12 2 3
2025 2 0 0

View full timeline →

What Is BIOTIN Used For?

IndicationReports
Product used for unknown indication 372
Vitamin supplementation 56
Multiple sclerosis 43
Alopecia 28
Constipation 26
Foetal exposure during pregnancy 22
Supplementation therapy 11
Intentional product misuse 10
Off label use 10
Vitamin d 10

BIOTIN vs Alternatives: Which Is Safer?

BIOTIN vs BIPERIDEN BIOTIN vs BIRCH TRITERPENES BIOTIN vs BISACODYL BIOTIN vs BISACODYL OR DOCUSATE BIOTIN vs BISMUTH BIOTIN vs BISMUTH SUBCITRATE BIOTIN vs BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE BIOTIN vs BISMUTH SUBSALICYLATE BIOTIN vs BISMUTH SUBSALICYLATE\METRONIDAZOLE\TETRACYCLINE BIOTIN vs BISOPROLOL

Official FDA Label for BIOTIN

Official prescribing information from the FDA-approved drug label.

Drug Description

Directions Directions Apply twice a day. Once in the morning and another time in the evening before bed Spray directly on top of the scalp in the area to be treated Using more than directed or more often will not improve results Continued use is necessary to lncrease and then malntain your hair regrowth

FDA Approved Uses (Indications)

INDICATIONS For the temporary relief of general weakness or fatigue, difficulty losing weight, dry or cracked skin, feeling cold, physical stiffness, inflexibility, or sugar cravings due to slow metabolism.*

Dosage & Administration

Apply half a capful twice a day to thescalp in the hair loss area. Massageinto the scalp with fingers, then washhands well. Using more or more often will notimprove results. Continued use isnecessary to increase and maintainhair regrowth, otherwise, hair loss willbegin again. Complete instructions on howto use and get the best results. 1: PREP HANDS WITH COLD WATERRinse your fingers in cold water anddry them. Note: Foam will melt oncontact with warm surfaces 2: OPEN THE BOTTLE SAFETY CAPAfter opening the cap, shake the canvigorously to ensure the liquid is fullydistributed. 3: DISPENSE VERTICALLY ONTO ACOLD SURFACEHold the can straight upside down. lfyou hold the can at an angle, the foammay not dispense properly. Press thenozzle to dispense half a capful offoam onto a cold surface (e.g., dish orcold hands). 4: APPLY TO SCALP, NOT HAIRPart your hair to expose the hair lossarea. Massage the foam into your scalp,not your hair. Repeat until all hair lossareas have been covered. 5: CLOSE CAP AND WASH HANDSReplace the cap, making sure it issecurely closed and out of the reach ofchildren. Wash hands and any surfacesthoroughly after use.

Warnings

Warnings 1. For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. 2. Discontinue use if any rritation or adverse reaction occurs. 3. If you are pregnant, nursing, or have any underlying medical conditions, consult your healthcare provider before using the product.

Precautions

PRECAUTIONS Keep away from heat and direct sunlight Place in a dry, cool place

Active Ingredient

Active ingredient(s)

Rosmarinus

Officinalis (Rosemary)

Leaf Oil

55% Biotin 0.001%

Inactive Ingredients

Inactive ingredients Water 97.65% Peg-40 Hydrogenated Castor 0il 0.15% Panthenol 0.15% Batana Oil 0.1% Rosmarinus Officinalis (Rosemary)

Leaf

0il 0.1% Ricinus Communis (Castor) 0il 0.1% Hydrolyzed Rice Protein 0.3% Phenoxyethanol 0.35% Undecylenamidopropyltnmonium Methosulfate 0.1%