35/100 · Moderate
Manufactured by Guangdong Aimu Biological Technology Co., Ltd
Biotin Adverse Events: Mild to Moderate Symptoms Predominate
70,312 FDA adverse event reports analyzed
Last updated: 2026-05-12
BIOTIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Guangdong Aimu Biological Technology Co., Ltd. Based on analysis of 70,312 FDA adverse event reports, BIOTIN has a safety score of 35 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for BIOTIN include FATIGUE, NAUSEA, ALOPECIA, HEADACHE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BIOTIN.
Biotin has a safety concern score of 35 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 70,312 adverse event reports for this medication, which is primarily manufactured by Guangdong Aimu Biological Technology Co., Ltd.
The most commonly reported adverse events include Fatigue, Nausea, Alopecia. Of classified reports, 47.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reported adverse events are mild to moderate in severity, with fatigue, nausea, and alopecia being the most common.
Reaction diversity is high, with over 100 distinct reactions reported, indicating a wide range of potential side effects. The serious adverse events represent a significant portion (47.4%) of the total reported reactions, highlighting the need for careful monitoring.
Patients taking Biotin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Biotin does not typically interact with other medications, but patients should be advised to consult a healthcare provider if they experience any unusual symptoms or if their condition worsens. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Biotin received a safety concern score of 35/100 (moderate concern). This is based on a 47.4% serious event ratio across 29,853 classified reports. The score accounts for 70,312 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 25,581, Male: 2,824, Unknown: 10. The most frequently reported age groups are age 68 (539 reports), age 62 (531 reports), age 65 (514 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 29,853 classified reports for BIOTIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Biotin does not typically interact with other medications, but patients should be advised to consult a healthcare provider if they experience any unusual symptoms or if their condition worsens.
If you are taking Biotin, here are important things to know. The most commonly reported side effects include fatigue, nausea, alopecia, headache, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for any new or worsening symptoms and report them to your healthcare provider. Follow the prescribed dosage and usage instructions carefully to minimize the risk of adverse events. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor biotin safety, and updates will be provided as necessary. Patients should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 70,312 adverse event reports associated with Biotin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Biotin include Fatigue, Nausea, Alopecia, Headache, Drug Ineffective. By volume, the top reported reactions are: Fatigue (3,046 reports), Nausea (2,251 reports), Alopecia (2,193 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Biotin.
Out of 29,853 classified reports, 14,151 (47.4%) were classified as serious and 15,702 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Biotin break down by patient sex as follows: Female: 25,581, Male: 2,824, Unknown: 10. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Biotin adverse events are: age 68: 539 reports, age 62: 531 reports, age 65: 514 reports, age 64: 507 reports, age 61: 498 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Biotin adverse event reports is Guangdong Aimu Biological Technology Co., Ltd. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Biotin include: Diarrhoea, Pain, Dizziness, Off Label Use, Arthralgia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Biotin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Biotin has a safety concern score of 35 out of 100 (moderate concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of reported adverse events are mild to moderate in severity, with fatigue, nausea, and alopecia being the most common.
Key safety signals identified in Biotin's adverse event data include: FATIGUE and NAUSEA are the most frequently reported reactions, suggesting these may be the most common side effects.. The high number of serious reactions (14,151) out of 29,853 total outcomes indicates a notable concern.. A wide range of reactions, including DEATH, DEPRESSION, and CHEST PAIN, are reported, indicating potential for severe adverse events.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Biotin does not typically interact with other medications, but patients should be advised to consult a healthcare provider if they experience any unusual symptoms or if their condition worsens. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Biotin.
Monitor for any new or worsening symptoms and report them to your healthcare provider. Follow the prescribed dosage and usage instructions carefully to minimize the risk of adverse events.
Biotin has 70,312 adverse event reports on file with the FDA. Reaction diversity is high, with over 100 distinct reactions reported, indicating a wide range of potential side effects. The volume of reports for Biotin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor biotin safety, and updates will be provided as necessary. Patients should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with BIOTIN:
Drugs related to BIOTIN based on therapeutic use, drug class, or shared indications: