Labetalol Pregnancy and Breastfeeding Warnings

Brand names: Normodyne, Trandate

Medically reviewed by Drugs.com. Last updated on Jul 22, 2025.

Labetalol Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated during the first trimester of pregnancy.

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

Risk summary: Extensive experience with use of this drug in pregnant women (based on various studies) has not identified a drug-related risk.

Animal studies have failed to reveal evidence of teratogenicity, although an increased incidence of fetal resorption was demonstrated in some studies at doses approximating the maximum recommended human dose. There are no controlled data in human pregnancy.

Beta adrenergic blocking agents may cause bradycardia in the fetus and newborn infant. During the final part of pregnancy and parturition these drugs should therefore only be given after weighing the needs of the mother against the risk to the fetus. This drug crosses the placental barrier and has been found to bind to the eyes of fetal animals. Perinatal and neonatal distress (bradycardia, hypotension, respiratory depression, hypoglycemia, hypothermia) has been rarely reported. Response to supportive measures (e.g. intravenous fluids and glucose) are usually prompt.

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 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

Labetalol Breastfeeding Warnings

AU: Use is contraindicated
UK: Use is not recommended
US: Caution is recommended

Excreted into human milk: Yes

Comment:
-The effects in the nursing infant are unknown.

Because of the low levels of this drug in breastmilk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in full-term breastfed infants. No special precautions are required in most infants; however, other agents may be preferred while nursing a preterm infant.

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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