Methylene Blue dosage in published studies and labels
These are the doses used for Methylene Blue in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Methylene blue has an FDA-approved human dosage for one use. As ProvayBlue it is given as 1 mg/kg intravenously over 5–30 minutes for acquired methemoglobinemia, with one repeat dose of up to 1 mg/kg after an hour if needed. Oral use has been studied in trials, for example 195 mg a day as an add-on in bipolar disorder, but no oral dose is approved.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 1 mg/kg IV, repeatable once (approved label) |
| Route | Intravenous (approved) · Oral (trials only) |
| Frequency | Single dose, repeatable once after one hour |
| Duration studied | Acute treatment |
| Evidence level | FDA Approved |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — ProvayBlueFDA-approved label · FDA prescribing information | Pediatric and adult patients with acquired methemoglobinemia | 1 mg/kg; a repeat dose of up to 1 mg/kg may follow one hour after the first if methemoglobin stays above 30% or symptoms persist. A single 1 mg/kg dose in moderate or severe renal impairment. | Intravenous, over 5–30 minutes | Once, repeatable once | Acute | Reduction of methemoglobin | PROVAYBLUE (methylene blue) injection — FDA prescribing information, DailyMed |
| Randomised crossover trial — residual symptoms of bipolar disorder (2017)Clinical trial · Double-blind randomised crossover trial (NCT00214877) | Adults with bipolar disorder taking lamotrigine (n=37) | 195 mg a day (active) versus 15 mg a day (used as the placebo arm) | Oral | Daily | 6-month crossover trial | Depression and anxiety scores improved on the active dose; cognitive measures did not change significantly | Methylene blue treatment for residual symptoms of bipolar disorder: randomised crossover study. Br J Psychiatry. 2017. |
| Neuroimaging crossover study in bipolar disorder (2024)Clinical trial · Single-blind randomised crossover study | Euthymic adults with bipolar I disorder and matched healthy controls (n=30) | 0.5 mg/kg, single infusion | Intravenous | Once | Single session | Change in cerebral blood flow and oxygen metabolism on MRI | Altered oxidative neurometabolic response to methylene blue in bipolar disorder revealed by quantitative neuroimaging. J Affect Disord. 2024. |
Where sources disagree
- The only approved use is intravenous treatment of acquired methemoglobinemia. Low-dose oral protocols published for energy or cognition do not come from the label, and the oral trials above tested specific doses in specific patient groups.
- The label contraindicates methylene blue in G6PD deficiency because of the risk of hemolytic anemia, and carries a boxed warning for serious or fatal serotonin syndrome when combined with serotonergic drugs (such as SSRIs, SNRIs and MAOIs) or opioids.
- Methylene blue is a small-molecule dye, not a peptide. It is listed here because it is widely discussed alongside research peptides.