Some authorities recommend this drug be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not Assigned

Risk Summary: Untreated hypertension during pregnancy can result in increased maternal risks.

Animal studies have failed to reveal evidence of adverse developmental effects in pregnant rabbits and rats at plasma concentrations of 10 and 4 times, respectively, the human AUC exposures with a 12 mg/day therapeutic dose. Reduced fetal survival was observed in animals at much higher doses. 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.

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Based on the amount of this drug detected in human milk, adverse effects would not be expected to occur in breastfed infants.

Use is contraindicated per some authorities.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references