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The FDA considers it a non-toxic substance under the Generally Recognized as Safe (GRAS) classification for specific applications

Safety: Preclinical studies show low toxicity across animal models (PubMed 32334036)

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The risk and severity of side effects increase with dose, duration of use, and misuse

In rats that received two ligations of the left colic artery and vein for 15 min, the ligations were removed, and the area was then reperfused for next 15 min (IC + RL rats), medication at that colon segment during reperfusion included BPC 157 (10 g) and saline bath of equal volume (control) at 1 min of reperfusion time