Evaluating the Safety of Oral Methylene Blue During Swallowing Assessment: A Systematic Review

European Archives of Oto-Rhino-Laryngology

Tariq, B., Simon, S. R., et al. (2021).

European Archives of Oto-Rhino-Laryngology, 378, 3155-3169.

This systematic review investigates the possibility of adverse events following oral administration of methylene blue and examines its safety as a food dye during swallowing assessment.

No funding received



Up to June 2020

Any peer-reviewed study design (excluding expert opinions, conference papers, descriptive reviews, case reports, experiments on animals or cadavers, and in vitro studies)

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<div>Among a pooled population of 1,902 participants, serious adverse events (AEs) related to oral administration of methylene blue were rare (<em>n</em> = 3, 0.16%). Non-serious adverse events (e.g., discolored urine, nausea, headache) were mild, ran their course without treatment, and showed a dose-related trend. This suggests that methylene blue is safe to use during clinical swallow studies and during endoscopic evaluations. Due to limitations including a low number of included studies (unclear if due to low prevalence of AEs or under reporting), additional research is warranted.</div>