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Leucovorin Pregnancy and Breastfeeding Warnings

Brand names: Wellcovorin

Medically reviewed by Drugs.com. Last updated on Jul 31, 2023.

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

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

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.

See references

See also

References for pregnancy information

  1. "Product Information. Wellcovorin (leucovorin)." Glaxo Wellcome, Research Triangle Park, NC.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2015) "Product Information. Leucovorin Calcium (leucovorin)." Epic Pharma LLC

References for breastfeeding information

  1. "Product Information. Wellcovorin (leucovorin)." Glaxo Wellcome, Research Triangle Park, NC.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. Briggs GG, Yaffe SJ., Freeman RK (2011) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Llippincott Williams & Wilkins
  5. (2015) "Product Information. Leucovorin Calcium (leucovorin)." Epic Pharma LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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