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Biotin Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 35 

Pyrexia (8483886-3)
on Jun 27, 2012 Male from UNITED STATES , weighting 180.3 lb, was treated with Biotin. Directly after, patient experienced the unwanted or unexpected Biotin side effects: pyrexia. Biotin dosage: N/A.
Associated medications used:
  • Lithium Carbonate
  • Clonazepam
  • Life Pak Tab Mens
  • Fish Oil
  • Levothyroxine Sodium
  • Cod Liver
  • Calcium/mag/zinc
  • Xeloda (Bid X2 Weeks Po)
Patient was hospitalized.

Menstruation Irregular (8476303-0)
Patient was taking Biotin. Patient felt the following Biotin side effects: menstruation irregular on Jun 26, 2012 from UNITED STATES Additional patient health information: Female , weighting 120.1 lb, was diagnosed with
  • medical diet
and. Biotin dosage: N/A.
Multiple prescriptions taken:
  • Plan B One-step (1.5 Milligram;)
  • Plan B One-step (1.5 Milligram;)
  • Plan B One-step (1.5 Milligram;)


Breast Cancer (8275572-X)
Adverse event was reported on Apr 04, 2012 by a Female taking Biotin (Dosage: N/A) . Location: UNITED STATES , 45 years of age, After Biotin was administered, patient encountered several Biotin side effects: breast cancer.
Multiple concurrent drugs taken:
  • Tylenol (caplet)
  • Synthroid
  • Ventolin Ds
  • Vitamin D
  • Tysabri


Meningitis (8225125-4)
on Mar 07, 2012 Female from SWITZERLAND , 58 years of age, was treated with Biotin. Directly after, patient experienced the unwanted or unexpected Biotin side effects: meningitis. Biotin dosage: N/A.
Associated medications used:
  • Calcium Dobesilate
  • Calcium Carbonate
  • Colecalciferol
  • Levothyroxine Sodium
  • Methotrexate (20 Mg/week)
  • Adalimumab (40mg Every 2 Weeks)
  • Alendronic Acid
  • Sibutramine Hydrochloride Monohydrate
Patient was hospitalized.


Breast Cancer (8210741-6)
on Mar 09, 2012 Female from UNITED STATES , 45 years of age, was treated with Biotin. Patient felt the following Biotin side effects: breast cancer. Biotin dosage: N/A.
Multiple prescriptions taken:
  • Vitamin D
  • Ventolin Ds
  • Synthroid
  • Tylenol
  • Tysabri


Heart Rate Increased, Fatigue, Malaise, Cardiac Flutter, Dyspnoea, Dyspepsia, Supraventricular Tachycardia, Chest Discomfort (8210385-6)
Patient was taking Biotin. After Biotin was administered, patient encountered several Biotin side effects: heart rate increased, fatigue, malaise, cardiac flutter, dyspnoea, dyspepsia, supraventricular tachycardia, chest discomfort on Apr 07, 2011 from UNITED STATES Additional patient health information: Female , weighting 198.0 lb, . Biotin dosage: N/A.
Multiple concurrent drugs taken:
  • Premarin
  • Lorazepam
  • Ativan
  • Multi-vitamin
  • Wellbutrin
  • Toprol-xl
  • Toprol-xl


Trichorrhexis, Rash Macular, Erythema, Alopecia (8198608-3)
Adverse event was reported on Dec 02, 2011 by a Female taking Biotin (Dosage: 1 Df, Unk) was diagnosed with
  • alopecia
  • osteoporosis postmenopausal
and. Location: UNITED STATES , 85 years of age, Directly after, patient experienced the unwanted or unexpected Biotin side effects: trichorrhexis, rash macular, erythema, alopecia.
Associated medications used:
  • Prolia (Unk Unk, Q6mo)
  • Calcium W/vitamin D (Unk)
  • Humulin R (Unk)
  • Atenolol (Unk)
  • Humalog (Unk)


Depression, Aggression, Crying, Alcohol Use, Euphoric Mood, Amnesia (8102432-7)
on Jan 31, 2012 Female from UNITED STATES , weighting 140.0 lb, was diagnosed with
  • nail disorder
  • hair disorder
and was treated with Biotin. Patient felt the following Biotin side effects: depression, aggression, crying, alcohol use, euphoric mood, amnesia. Biotin dosage: 5,000 Mcg Daily Mouth.

Injection Site Swelling, Injection Site Warmth, Injection Site Pain, Injection Site Erythema, Oedema Peripheral, Injection Site Pruritus (8100371-9)
on Nov 22, 2011 Female from UNITED STATES , 54 years of age, was treated with Biotin. After Biotin was administered, patient encountered several Biotin side effects: injection site swelling, injection site warmth, injection site pain, injection site erythema, oedema peripheral, injection site pruritus. Biotin dosage: N/A.
Multiple concurrent drugs taken:
  • Prilosec
  • Magnesium
  • Remifemin
  • Calcium
  • Fish Oil
  • Humira
  • Imuran
  • Potassium


Oedema Peripheral, Injection Site Pain (8094715-4)
Patient was taking Biotin. Directly after, patient experienced the unwanted or unexpected Biotin side effects: oedema peripheral, injection site pain on Dec 20, 2011 from UNITED STATES Additional patient health information: Female , 52 years of age, was diagnosed with
  • dry mouth
and. Biotin dosage: N/A.
Associated medications used:
  • Humira
  • Omeprazole
  • Lexapro
  • Oxycontin
  • Arthrotec
  • Combivent
  • Crestor
  • Valium


Injection Site Haematoma (8092821-1)
Adverse event was reported on Aug 15, 2011 by a Female taking Biotin (Dosage: N/A) . Location: UNITED STATES , weighting 205.2 lb, Patient felt the following Biotin side effects: injection site haematoma.
Multiple prescriptions taken:
  • Humira
  • Zoloft
  • Zetia
  • Omeprazole
  • Crestor
  • Niaspan
  • Folic Acid
  • Fish Oil


Low Density Lipoprotein Increased, Alopecia (8088641-4)
on Apr 29, 2011 Female from UNITED STATES , weighting 238.2 lb, was diagnosed with
  • vitamin supplementation
  • mineral supplementation
and was treated with Biotin. After Biotin was administered, patient encountered several Biotin side effects: low density lipoprotein increased, alopecia. Biotin dosage: N/A.
Multiple concurrent drugs taken:
  • Chromium Chloride
  • Same
  • Methotrexate
  • Red Rice Yeast
  • Lugols Solution 5%
  • Humira
  • Methotrexate
  • Humira


Erythema, Rash Macular, Trichorrhexis, Alopecia (8068724-5)
on Dec 02, 2011 Female from UNITED STATES , 85 years of age, was diagnosed with
  • alopecia
  • cardiac disorder
and was treated with Biotin. Directly after, patient experienced the unwanted or unexpected Biotin side effects: erythema, rash macular, trichorrhexis, alopecia. Biotin dosage: 1 Df, Unk.
Associated medications used:
  • Atenolol (Unk)


Cough, Alopecia (7990528-X)
Patient was taking Biotine. Patient felt the following Biotin side effects: cough, alopecia on Jun 01, 2011 from UNITED STATES Additional patient health information: Female , 84 years of age, weighting 134.9 lb, . Biotine dosage: N/A.
Multiple prescriptions taken:
  • Crestor
  • Toprol-xl


Intentional Self-injury, Irritability, Suicidal Ideation (7935608-X)
Adverse event was reported on Nov 11, 2011 by a Female taking Biotin (Dosage: N/A) . Location: UNITED STATES , weighting 108.0 lb, After Biotin was administered, patient encountered several Biotin side effects: intentional self-injury, irritability, suicidal ideation.
Multiple concurrent drugs taken:
  • Buspar
  • Contraceptives
  • Strattera (18 Mg, Each Morning)
  • Citalopram Hydrobromide (Unk)


Nausea, Hypoaesthesia, Dyspnoea, Stress (7901999-9)
on Nov 01, 2011 Female from UNITED STATES , 45 years of age, was treated with Biotin. Directly after, patient experienced the unwanted or unexpected Biotin side effects: nausea, hypoaesthesia, dyspnoea, stress. Biotin dosage: N/A.
Associated medications used:
  • Diclofenac Sodium
  • Seroquel
  • Fish Oil
  • Alprazolam
  • Requip (.25mg Per Day)
  • Proventil
  • Prednisone
  • Flexeril
Patient was hospitalized.

Stress, Nausea, Dyspnoea, Hypoaesthesia (7833819-5)
on Oct 18, 2011 Female from UNITED STATES , 45 years of age, was treated with Biotin. Patient felt the following Biotin side effects: stress, nausea, dyspnoea, hypoaesthesia. Biotin dosage: N/A.
Multiple prescriptions taken:
  • Fish Oil
  • Cranberry
  • Diclofenac
  • Advair Diskus 100/50 (1puff Twice Per Day)
  • Proventil
  • Alprazolam
  • Tussionex
  • Seroquel
Patient was hospitalized.

Dyspnoea, Deep Vein Thrombosis, Injury, Pain, Chest Pain, Pulmonary Embolism (7814650-3)
Patient was taking Biotin. After Biotin was administered, patient encountered several Biotin side effects: dyspnoea, deep vein thrombosis, injury, pain, chest pain, pulmonary embolism on Sep 30, 2011 from UNITED STATES Additional patient health information: Female , 43 years of age, weighting 162.0 lb, . Biotin dosage: Unk.
Multiple concurrent drugs taken:
  • Vitamin D (Unk Unk, Qd)
  • Sea Kelp (Unk)
  • Claritin (10 Mg, Qd)
  • Yaz (Unk)
  • Isometh-d-chlor (Unk)
  • Amoxicillin (500 Mg, Unk)
  • Veramyst (Unk Unk, Qd)
  • Multi-vitamins (Unk Unk, Qd)
Patient was hospitalized.

Fracture Delayed Union, Tibia Fracture, Foot Deformity, Hypertension, Basal Cell Carcinoma, Fall, Stress Fracture, Anxiety (7790808-7)
Adverse event was reported on Sep 21, 2011 by a Female taking Biotin (Dosage: N/A) . Location: UNITED STATES , 57 years of age, weighting 121.3 lb, Directly after, patient experienced the unwanted or unexpected Biotin side effects: fracture delayed union, tibia fracture, foot deformity, hypertension, basal cell carcinoma, fall, stress fracture, anxiety.
Associated medications used:
  • Fosamax Plus D
  • Centrum
  • Fosamax
  • Ascorbic Acid
  • Calcium Carbonate
  • Fosamax
  • Citracal
  • Cholecalciferol
Patient was hospitalized and became disabled.

Throat Irritation, Flatulence, Dyspepsia, Gastrointestinal Disorder (7761596-5)
on Sep 06, 2011 Female from UNITED STATES , weighting 148.0 lb, was treated with Biotin. Patient felt the following Biotin side effects: throat irritation, flatulence, dyspepsia, gastrointestinal disorder. Biotin dosage: N/A.
Multiple prescriptions taken:
  • Calcium Carbonate
  • Glucosamine/condroitin
  • Pradaxa (300 Mg)
  • Metoprolol Tartrate
  • Diovan


Aspiration, Economic Problem, Pneumonia, Pulmonary Infarction, Musculoskeletal Stiffness, Emotional Distress, Cervicobrachial Syndrome, Lung Neoplasm, Scoliosis (7749787-0)
on Aug 25, 2011 Female from UNITED STATES , 41 years of age, weighting 128.0 lb, was treated with Biotin. After Biotin was administered, patient encountered several Biotin side effects: aspiration, economic problem, pneumonia, pulmonary infarction, musculoskeletal stiffness, emotional distress, cervicobrachial syndrome, lung neoplasm, scoliosis. Biotin dosage: N/A.
Multiple concurrent drugs taken:
  • Centrum Cardio
  • Cephalexin
  • Atenolol
  • Nuvaring (Vag)
  • Nuvaring (Vag)
  • Fish Oil
  • Naphcon
  • Coumadin
Patient was hospitalized and became disabled.

Dyspepsia, Gastrointestinal Disorder (7710351-0)
Patient was taking Biotin. Directly after, patient experienced the unwanted or unexpected Biotin side effects: dyspepsia, gastrointestinal disorder on Jul 06, 2011 from UNITED STATES Additional patient health information: Female , 73 years of age, . Biotin dosage: N/A.
Associated medications used:
  • Chondroitin Sulfate + Glucosamine
  • Simavastatin
  • Diovan
  • Carvedilol
  • Lansoprazole
  • Aspirin
  • Prevacid
  • Lansoprazole


Femur Fracture, Fracture Nonunion, Back Pain, Hypertension, Device Failure, Impaired Healing, Vitamin D Deficiency (7689093-6)
Adverse event was reported on Aug 15, 2011 by a Female taking Biotin (Dosage: N/A) . Location: UNITED STATES , 76 years of age, Patient felt the following Biotin side effects: femur fracture, fracture nonunion, back pain, hypertension, device failure, impaired healing, vitamin d deficiency.
Multiple prescriptions taken:
  • Vitamin E
  • Flaxseed
  • Niacin
  • Aspirin
  • Ascorbic Acid
Patient was hospitalized.

Asthenia, Dehydration, Diarrhoea, Electrocardiogram Change, Blood Pressure Decreased, Heart Rate Increased (7670217-1)
on Aug 01, 2011 Female from UNITED STATES , weighting 208.0 lb, was treated with Biotin. After Biotin was administered, patient encountered several Biotin side effects: asthenia, dehydration, diarrhoea, electrocardiogram change, blood pressure decreased, heart rate increased. Biotin dosage: N/A.
Multiple concurrent drugs taken:
  • Pradaxa (300 Mg)
  • Calcium Carbonate (500 Mg)
  • Vitamin B-12
  • Vitamin B6
  • Copper
  • Flaxseed Oil
  • Warfarin Sodium (6 Mg)
  • Magnesium
Patient was hospitalized.

Pruritus, Flushing, Feeling Hot, Paraesthesia (7665625-9)
on Jul 15, 2011 Female from UNITED STATES , weighting 159.1 lb, was treated with Biotin. Directly after, patient experienced the unwanted or unexpected Biotin side effects: pruritus, flushing, feeling hot, paraesthesia. Biotin dosage: N/A.
Associated medications used:
  • Nexium
  • Lovaza
  • Calcium Citrate (4 Tablets, Everyday)
  • Effexor
  • Niaspan (At Bedtime)


Showing 1-25 of 35 

Biotin Health Episodes

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Biotin Information

Alternative BIOTIN Names:BIONA-VIT BONOGEN ACTIVATOR HAIRQ-PLUS SPAI-SONS TK-NAX

Active Ingredient: BIOTIN

More About Biotin

Side Effects reported to FDA: 35. View Biotin Adverse Reports

Biotin safety alerts: No

Reported deaths: 1

Reported hospitalizations: 11

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