Biotin adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Biotin
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Arteriolar vasodilator
Also reported as: Biotin 5000, Biotin /08249501/, Biotin Tab

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From October 2004 to June 2026, FDA received 769 adverse event reports that name Biotin. In these reports the drug is a suspect or interacting product.

In the same period, 30,474 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 72 reports in the 12 months to June 2026 and 74 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 72 (under 0.1%) name Biotin. Reports from other health professionals were 44.9% of the reports that name Biotin and 19.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Biotin is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 24 reports that name Biotin.
In January to March 2026, FDA received 23.
In April to June 2025, FDA received 21.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 198 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 739 of the 769 reports (96.1%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 198 terms.

Reaction terms in the reports that name Biotin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 769 reports
Dyspnoeashortness of breath	192	25%
Off label useused for a purpose or in a way not on the label	161	20.9%
Somnolencedrowsiness	150	19.5%
Coronary artery disease	149	19.4%
Cough	140	18.2%
Wheezing	132	17.2%
Obstructive airways disorder	131	17%
Muscle spasmsmuscle cramps	124	16.1%
Chest discomfort	123	16%
Abdominal distensiona bloated abdomen	122	15.9%
Atrial fibrillationan irregular heart rhythm	120	15.6%
Dyspnoea exertional	119	15.5%
Eosinophilia	119	15.5%
Myoglobin blood increased	119	15.5%
Brain natriuretic peptide increased	118	15.3%
Dysphoniaa hoarse voice	118	15.3%
Fractional exhaled nitric oxide increased	118	15.3%
Nasopharyngitisa cold	118	15.3%
Sensation of foreign body	117	15.2%
Cardiac disorder	115	15%
Plantar fasciitis	115	15%
Condition aggravatedthe condition being treated got worse	108	14%
Nauseafeeling sick	108	14%
Stress	108	14%
Drug ineffectivethe medicine did not work as expected	107	13.9%
General physical health deteriorationgeneral decline in health	107	13.9%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	106	13.8%
Multiple organ dysfunction syndromeseveral organs failing	105	13.7%
Hyponatraemialow blood sodium	104	13.5%
Obstructive sleep apnoea syndrome	103	13.4%
Sepsisa severe body-wide response to infection	103	13.4%
Exostosis	102	13.3%
Pneumothoraxa collapsed lung	102	13.3%
Incorrect route of product administrationthe product was given by the wrong route	98	12.7%
Secretion discharge	97	12.6%
Vomitingbeing sick	97	12.6%
Constipation	96	12.5%
Abdominal painstomach or belly pain	93	12.1%
Appendicitis	92	12%
Ascitesfluid in the abdomen	92	12%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	92	12%
Myasthenia gravis	91	11.8%
Anaemialow red blood cells	90	11.7%
Appendicolith	90	11.7%
Neuralgia	90	11.7%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	89	11.6%
Diabetes mellitusdiabetes	89	11.6%
Sleep disordera sleep problem	89	11.6%
Swelling	89	11.6%
Thrombosis	89	11.6%

Download all 198 terms of Biotin (CSV)

The counts add to more than 769 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Biotin, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	1	1	0	0	0	0	0	1	0
2005	1	1	0	0	0	0	0	1	0
2006	0	0	0	0	0	0	0	0	0
2007	0	0	0	0	0	0	0	0	0
2008	1	0	0	0	0	0	0	0	1
2009	4	3	0	1	0	0	0	2	1
2010	1	0	0	0	0	0	0	0	1
2011	4	2	0	0	1	0	0	2	2
2012	15	10	0	1	1	1	0	8	5
2013	10	7	1	0	1	1	0	5	3
2014	8	6	0	0	2	0	0	5	2
2015	26	13	1	0	3	2	0	10	13
2016	13	3	0	0	1	0	0	2	10
2017	24	10	1	1	1	0	0	8	14
2018	28	15	1	0	5	0	0	12	13
2019	53	40	0	1	22	1	3	33	13
2020	32	22	2	0	13	1	2	11	10
2021	33	14	0	4	5	0	0	12	19
2022	101	85	18	1	15	4	0	71	16
2023	152	138	59	37	78	48	2	129	14
2024	87	80	13	13	24	12	4	78	7
2025	76	68	31	26	36	31	23	62	8
2026	99	88	44	41	49	42	37	83	11

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Biotin, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Biotin, by the year in which FDA received them
Year	Reports
2004	1
2005	1
2008	1
2009	3
2010	2
2011	4
2012	18
2013	8
2014	12
2015	30
2016	23
2017	31
2018	33
2019	49
2020	37
2021	59
2022	142
2023	137
2024	76
2025	55
2026	47

Reports that name Biotin, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Biotin
Age	Reports	Share
Under 2	23	3%
2 to 11	16	2.1%
12 to 17	1	0.1%
18 to 44	66	8.6%
45 to 64	128	16.6%
65 to 74	55	7.2%
75 and over	231	30%
Age not given	249	32.4%

Sex of the patient in the reports that name Biotin
Sex	Reports	Share
Female	355	46.2%
Male	334	43.4%
Unknown or not given	80	10.4%

Type of reporter in the reports that name Biotin
Reporter	Reports	Share
Physician	134	17.4%
Pharmacist	20	2.6%
Other health professional	345	44.9%
Lawyer	1	0.1%
Consumer or non-health professional	248	32.2%
Not given	21	2.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 38.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Biotin record
Indication as recorded (MedDRA)	Reports	Share
Vitamin supplementation	53	6.9%
Alopecia	33	4.3%
Foetal exposure during pregnancy	20	2.6%
Multiple sclerosis	18	2.3%
Constipation	9	1.2%
Seizure	8	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 769 reports.

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These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for BiotinThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Biotin: adverse event reports that FDA received. https://reportedreactions.com/drug/biotin/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Biotin as a suspect or interacting product. The 30,474 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Biotin was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Biotin?

No. It is a count of what people reported to FDA: 769 reports from October 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (44.9%), consumer or non-health professional (32.2%) and physician (17.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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