Animal studies have not been conducted with this drug. There are no controlled data in human pregnancy; it is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

See references

Caution is recommended; benefit to the mother should outweigh risk to the infant.

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

Comments: The effects in the nursing infant are unknown.

No information exists regarding excretion into human breastmilk. When this drug was added to expressed breastmilk and/or formula, potassium, calcium, and creatinine levels in infants decreased; infants did not have clinically noticeable side effects. Secretion into breastmilk is predicted to be unlikely as this drug is not orally absorbed.

See references