In rats, the oral LD50 is 525mg/kg and the inhalation LC50 is >2.17mg/L over 4 hoursMSDS.

There is insufficient data regarding the carcinogenicity, mutagenicity, or fertility impairment of lithium carbonateFDA Label. However, studies in rats and mice have shown repeated daily dosing of lithium carbonate result in adverse effects on male reproductive organs, spermatogenesis, and testosterone levelsFDA Label.

There is conflicting evidence regarding the incidence of cardiovascular abnormalities in first trimester administration of lithiumFDA Label. Animal studies have shown adverse effects on the fetus and fertility overallFDA Label. The risk and benefit of lithium use in pregnancy must be weighed and should lithium treatment continue in pregnancy, serum lithium concentrations should be regularly monitored, dosages should be adjusted, and lithium should be decreased or stopped 2 or 3 days before delivery to avoid maternal and/or neonatal toxicityFDA Label.

Breastfeeding is not recommended with maternal lithium use but if it is continued, the infant should be monitored for thyroid function and symptoms of lithium toxicity such as hypertonia, hypothermia, cyanosis, and ECG changesFDA Label.

Safety in effectiveness in patients under 12 years has not been established, however dosing for patients 12 years and older is similar to that of adult patientsFDA Label.

Safety in geriatric patients has not been established, however caution is advised when using lithium as this population is more likely to have impaired renal functionFDA Label.

Patients with creatinine clearance between 30mL/min and 89mL/min should be started at a lower dose and slowly titrated to the correct dose while monitoring serum lithium levelsFDA Label. Patients with a creatinine clearance less than 30mL/min should not take lithium, especially in the case of a low sodium dietFDA Label.