BIOTIN: 695 Adverse Event Reports & Safety Profile
Boost Your Natural Energy & Metabolism
Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.
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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is BIOTIN Used For?
| Indication | Reports |
|---|---|
| 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?
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%