Animal studies of administration during organogenesis showed fetal malformations and decreased fetal weights at maternally toxic doses; lower doses (approximately twice the human dosage) did not show maternal or fetal effects. No effects on fertility were seen in animal studies. There are no controlled data in human pregnancy.

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:
-Iron deficiency anemia during the first trimester can often be treated with oral iron.
-Use is not recommended in women not using adequate contraception.
-Untreated iron deficiency anemia is associated with post-partum anemia, and increased risk of preterm delivery and low birth weight.

-Treatment with this product should be confined to the second and third trimester if benefit outweighs risk. (UK)

See references

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references