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Citicoline exhibits very low toxicity profile in humans. In a short term, placebo-controlled, cross-over study, 12 healthy adults took citicoline at daily doses of 600 and 1000 mg or placebo for consecutive five-day periods.
Transient headaches occurred in four subjects on 600-mg dose, five on the 1000-mg dose, and one in placebo.
No changes or abnormalities were observed in hematology, clinical biochemistry or neurological test.
The LD50 of a single intravenous dose of citicoline was 4,600 mg/kg and 4,150 mg/kg in mice and rats, respectively.
In an unpublished acute toxicity study, free-base citicoline was administered to male and female rats at a dose of 2000 mg/kg body weight for 14 days. No changes in body weight, deaths, clinical symptoms or gross pathological changes were observed.
