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Ergocalciferol Pregnancy and Breastfeeding Warnings

Brand names: Calcidol, Calciferol, Drisdol, Vitamin D2

Medically reviewed by Drugs.com. Last updated on Oct 3, 2023.

Ergocalciferol Pregnancy Warnings

Safety has not been established during pregnancy. Use only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: Exempt
US FDA pregnancy category: C

Comments:
-Avoid use of vitamin D in excess of the recommended dietary allowance.
-The safety of vitamin D doses in excess of 400 international units has not been established.

Animal studies have shown fetal abnormalities associated with hypervitaminosis D, similar to supravalvular aortic stenosis syndrome. There are no controlled data in human pregnancy.

AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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

Ergocalciferol Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-Large maternal doses of vitamin D led to hypercalcemia in a child.
-Monitoring of the infant's serum calcium may be needed.
-The US Recommended Daily Allowance for lactating women is 600 international units per day.

See references

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Drisdol (ergocalciferol). sanofi-aventis. 2016.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. National Institutes of Health, Office of Dietary Supplements. Vitamin D. Fact Sheet for Health Professionals. https://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/ 2016.
  3. Product Information. Drisdol (ergocalciferol). sanofi-aventis. 2016.

Further information

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