Glutathione
Clinical reviewer: Jacob Moore, MD · Last checked September 16, 2026
What is glutathione?
Glutathione is a tripeptide of glutamate, cysteine and glycine made in the body. It is sold in oral and injectable forms and studied as an antioxidant. FDA lists it as a Category 1 bulk substance under evaluation for compounding; a 2022 advisory vote favored adding it to the 503A list, and 2026 warnings flag contamination risk in some injectable products.
What does research show about oral glutathione?
A 2015 randomized, double-blind, placebo-controlled trial gave 54 non-smoking adults oral glutathione at 250 or 1,000 mg per day for six months [1]. Blood glutathione rose at one, three and six months at both doses; in the high-dose group, levels in red blood cells, plasma and lymphocytes were 30 to 35 percent higher than baseline by six months [1]. After a one-month washout, levels returned to baseline [1]. The trial measured blood levels only, not any clinical outcome.
What is glutathione's FDA compounding status?
FDA's list of nominated bulk substances, updated May 14, 2026, places glutathione in Category 1, meaning it is under evaluation for the bulks list [2]. That status followed a June 2022 meeting where FDA had proposed not adding glutathione to the 503A bulks list, but the advisory committee voted 8 yes, 5 no, 1 abstain in favor of adding it; members voting no cited insufficient evidence of effectiveness [3].
Why does injectable grade matter?
FDA has reminded compounders not to use dietary-supplement-grade glutathione in injectable products [4]. It is aware of at least 30 patients who had adverse events after receiving IV glutathione traced to one supplier's lot — fever, chills, pain, dizziness, and shock- or sepsis-like symptoms, some requiring hospitalization [4]. FDA said ingredients labeled for dietary-supplement use may contain impurities, including endotoxins, that are dangerous when administered as an injectable drug [4].
Related terms
Sources
- Richie JP et al. Randomized controlled trial of oral glutathione supplementation on body stores of glutathione. Eur J Nutr, 2015.
- FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Updated May 14, 2026)
- FDA — Pharmacy Compounding Advisory Committee Meeting Summary Minutes, June 8, 2022
- FDA — FDA Reminds Compounders Not to Use Dietary Supplement Grade Glutathione for Injectables
This entry is for education and is not medical advice. Talk with a licensed clinician about your own situation before starting, stopping, or changing any treatment.
