Glutathione — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for Glutathione as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Injection-site reaction | — | — | — | Reported |
| Severe adverse events with unlicensed intravenous skin-lightening use | — | — | — | Regulatory authorities in several jurisdictions have issued warnings following reports of severe reactions including Stevens-Johnson syndrome, renal impairment and thyroid dysfunction associated with high-dose intravenous glutathione marketed for skin lightening |
| Bronchospasm with nebulised administration | — | — | — | Reported in people with asthma |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- Known hypersensitivity
- Asthma for nebulised administration
§4.3Warnings and precautions
- High-dose intravenous glutathione for skin lightening has been the subject of regulatory safety warnings in several jurisdictions
- Compounded parenteral preparations carry sterility, endotoxin and particulate risks
- The thiol oxidises readily; a preparation that has oxidised to the disulfide is a different substance
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.