Leucovorin Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: A
US FDA pregnancy category: C
Animal studies using doses at least 50 times the human dose did not show fetal harm. Use by a large number of pregnant women has not shown increased malformations or other harmful effects on the fetus; however safety has not been established, so caution is recommended. There are no controlled data in human pregnancy.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
Leucovorin Breastfeeding Warnings
It is not known whether folinic acid is excreted into human milk. A similar compound, folate (folic acid) is actively excreted into human milk. Adverse effects in nursing infants have not been associated with the use of folic acid during lactation.
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
See references