Animal studies have failed to reveal evidence of teratogenicity. Reproductive toxicity was seen at high multiples of human doses and developmental toxicity at doses greater than those used clinically. There are no controlled data in human pregnancy.

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 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.

Benefit should outweigh risk

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Risk Summary: Data are insufficient to inform a drug-associated risk of adverse pregnancy related outcomes; animal data has shown developmental toxicity at doses greater than those used clinically.

Comments:
-Insufficient animal reproduction studies have been performed to conclude that this drug poses no teratogenic risk.

See references

Not recommended

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

Comments:
-Due to the potential for serious adverse reactions in breastfed infant, including hypertensive crisis, breastfeeding is not recommended during treatment.
-Some authorities recommend avoiding breastfeeding for 7 days after the final dose.

See references