Betaxolol Pregnancy and Breastfeeding Warnings

Brand names: Kerlone

Medically reviewed by Drugs.com. Last updated on Jul 31, 2025.

Betaxolol Pregnancy Warnings

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

US FDA pregnancy category: C

Comment: Monitor for the signs and symptoms of beta blockade (e.g., bradycardia, respiratory distress, and hypoglycemia) for 3 to 5 days after birth.

Animal studies at dose levels associated with maternal toxicity (600 times the maximum recommended human dose) have revealed postimplantation loss, skeletal and visceral abnormalities, and reductions in litter size and weight. Beta-adrenergic blocking agents decrease placental perfusion which may result in premature and immature deliveries and fetal death. 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.

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Betaxolol Breastfeeding Warnings

Use caution; other beta-blocking agents may be preferred

Excreted into human milk: Yes

Comment: Breastfed infants should be monitored for the signs and symptoms of beta blockade, for example, bradycardia, respiratory distress, and hypoglycemia.

Beta-adrenergic blocking agents with similar lactation characteristics to this drug have caused adverse events in breastfed newborns. This drug is extensively excreted into breastmilk and is expected to have accumulation in the infant due to its low protein binding, low renal excretion, and long half-life.

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Further information

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