Nicardipine Pregnancy and Breastfeeding Warnings

Brand names: Cardene, Cardene IV, Cardene SR

Medically reviewed by Drugs.com. Last updated on Jun 20, 2025.

Nicardipine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated.

US FDA pregnancy category:
-IV infusion: C
-Oral capsules: Not assigned

Risk summary: Inadequate data available on the use of this drug in pregnant women to inform a drug-related risk. An embryocidal effect was observed in animal studies.

Animal studies have revealed evidence of embryolethality and fetal harm. In humans, transient fetal heart rate decelerations and neonatal hypotension and acidosis (pH less than 7.25) have been reported. There are no controlled data in human pregnancy.

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.

See references

Nicardipine Breastfeeding Warnings

Use should be avoided; however, this drug has been used without apparent harmful effects. Use is contraindicated per some authorities.

Excreted into human milk: Yes (in small amounts)

In two studies involving a total of 18 infants exposed to this drug through breast milk during the postpartum period, the calculated daily infant dose was less than 0.3 mcg and there were no adverse events observed.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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