Vitamin B12 (Methylcobalamin)

Status

Dietary supplement (US). No FDA-approved methylcobalamin drug product was found in Drugs@FDA (retrieved 25 October 2026). The approved B12 injections for pernicious anaemia and deficiency are cyanocobalamin and hydroxocobalamin, different molecules whose approvals do not transfer. Methylcobalamin injectable preparations are generally compounded rather than FDA-approved. Oral supplements are dietary supplements and are not reviewed for efficacy.

What it is

An injectable or oral vitamin used for deficiency and energy tracking.

What published research measured

Methylcobalamin, one of the two coenzyme forms of vitamin B12 active in human metabolism. Its established use is correction of deficiency, where the evidence is unambiguous and the consequences of not treating — macrocytic anaemia and, more importantly, irreversible subacute combined degeneration of the spinal cord — are serious. What the literature does not support is benefit in people who are replete: randomized trials of B12 supplementation in non-deficient adults show no improvement in energy, cognition or mood, which is the use that drives most injection clinic demand. Deficiency is more common in specific groups — vegans, people on metformin long term, those on proton pump inhibitors, and anyone with pernicious anaemia or ileal disease — and testing matters because high folate or folic acid intake can correct the anaemia of B12 deficiency while neurological damage progresses.

Source

FDA labeling for cyanocobalamin injection

Sources

No linked primary source is on file for this entry yet.

Educational use only, never medical advice. No doses.