Since 1972 dozens of clinical trials reported in the medical literature, involving thousands of patients have documented the benefits of palmitoylethanolamide. These have shown that palmitoylethanolamide is an effective and safe natural compound to use. In these studies, many of which included elderly and child subjects, no negative side effects have been identified.
In clinical studies, doses up to 100 mg per kg of body weight per day have been used without any adverse effects that could be distinguished from placebo effects. The LD50 is not determinable because the substance is a natural fat.
Whether it is safe to use palmitoylethanolamide during pregnancy or lactation is still insufficiently investigated. For individuals who suffer from renal or hepatic conditions it is generally advised to start cautiously with a single daily dose of 400 mg and increase slowly. To date, no adverse interactions between palmitoylethanolamide and regular medicines have come to light.
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