Reproduction studies in rats and rabbits at higher than the maximum human recommended dose have not revealed evidence of impaired fertility or harm to the fetus. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus and its use is considered essential.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Comments:
-Check thyroid function in neonates during the first week of life, following administration of iodinated contrast agents to the mother during pregnancy.
-Repeat testing of thyroid function at 2 to 6 weeks of age, particularly in low birth weight or premature newborn.

See references

Caution is recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-Because the amount of contrast medium excreted in human breast milk appears to be low and only minimal amounts are absorbed by the intestine, some experts recommend continuing breast feeding normally.

See references