What the label lists and what reports show
Biotin side effects
Biotin's FDA label lists its adverse reactions in its own words. FAERS holds 31,021 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (3,177 reports).
- No generic listed
- Over the counter
Check it at the source: the biotin FDA label on DailyMed (effective May 9, 2022); the FDA FAERS public dashboard.
What do FAERS reports show?
31,021 reports list biotin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 966 are coded as a death and 5,783 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Biotin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions