Animal studies have shown teratogenic and embryocidal outcomes at about 3 times the maximum human dose. No consistent adverse fetal effects were seen at doses of 50 mg/kg or less in animal models. Fetal and maternal toxicity were seen at doses over 90 mg iron/kg. Animal models were not iron deficient. There are no controlled data in human pregnancy. It appears that some iron does cross the placenta, but the form of the iron that crosses is not clear.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Comments:
-This drug was teratogenic in animal models at about 3 times the maximum human dose.

See references

Caution is recommended.

Excreted into human milk: Yes

Comments:
-Traces of unmetabolized drug are excreted in human milk.

See references