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

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

Animal studies have revealed decreased litter size in rats at doses greater than 225 times the usual maximum recommended human dose. In humans, use of this drug alone or with other hypotensive agents for severe hypertension in pregnant women failed to reveal fetal or neonatal abnormalities or adverse effects. 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 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.

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An alternate drug may be preferred, especially while breastfeeding a newborn or preterm infant. Caution is recommended if this drug is used during breastfeeding; benefit should outweigh risk per some authorities.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references