Animal studies showed fetal abnormalities (central nervous system, eye, and palate malformations) in overdose models. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use of doses above the recommended daily allowance is contraindicated.

AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned

Comments:
-The safety of doses exceeding 6000 units vitamin A in pregnancy has not been established.
-Some authorities caution against use of high doses of vitamin A during pregnancy or in those who may become pregnant.
-Doses above the recommended dietary allowance may cause fetal harm; fetal abnormalities were seen in animal overdose models.
-If patients become pregnant, apprise them of potential fetal harms.

See references

Use is considered acceptable; caution is recommended.


Excreted into human milk: Yes

Comments:
-Vitamin A is a normal component of human milk.
-Modest supplemental vitamin A causes modest increases in vitamin A in milk.
-High doses should be avoided during breastfeeding.

See references