methylfolate

What the FDA Data Shows for methylfolate

The FDA label for methylfolate (sold under brand names such as Deplin) classifies it as a prescription-only medication in the Active Folate (L-methylfolate) class. This medicine is a multivitamin and mineral supplement. Official labeling lists 1 commonly reported side effect, including Allergic reaction (skin rash, itching, hives).

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. Interaction data is drawn directly from FDA-approved prescribing information. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.