Animal studies have revealed evidence of fetolethality. In humans, a small number of cases have reported adverse events, including stillbirths, in pregnant women with severe pregnancy-induced hypertension who were treated with this drug. However, methodological limitations preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of this drug during pregnancy. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

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 clearly needed.

AU TGA pregnancy category: C
US FDA pregnancy category: C (Nitropress); Not assigned.

Risk Summary: This drug may lead to cyanide exposure and potential adverse effects in the fetus. Insufficient data exist to inform a drug-associated risk of adverse pregnancy related outcomes.

Comments: Pregnant women should be apprised of the potential risk to a fetus.

See references

Use is not recommended unless the benefit outweighs the risk.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

This drug is unlikely to appear in breastmilk due to its short half-life. However, thiocyanate, a toxic metabolite of this drug, is excreted into breastmilk and can be directly toxic to the nursing infant. Cyanide, another toxic metabolite of this drug, may also be excreted into breastmilk.

See references