Levalbuterol Pregnancy and Breastfeeding Warnings

Brand names: Xopenex, Xopenex Concentrate, Xopenex HFA

Medically reviewed by Drugs.com. Last updated on Aug 1, 2025.

Levalbuterol Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-The potential beta-adrenergic agonist effect of this drug can interfere with uterine contractility.
-This drug is not approved for the management of preterm labor (tocolysis).
-A pregnancy exposure registry is available.

Congenital anomalies, including cleft palate and limb defects, have been reported in newborns of women treated with racemic albuterol, which contains the levalbuterol isomer (active ingredient of this drug).

In animal studies, oral administration of this drug to pregnant rabbits showed no evidence of teratogenicity at approximately 108 times the maximum recommended daily inhalation (MRDI) dose of this drug. However, other studies demonstrated that racemic albuterol sulfate was teratogenic in mice and rabbits at doses comparable to the human therapeutic range. Pregnant mice administered racemic albuterol sulfate subcutaneously had a dose-related increased incidence of cleft palate in their fetuses. In addition, oral administration of racemic albuterol sulfate to pregnant rabbits resulted in an increased incidence of cranioschisis in fetuses. There are no adequate and well controlled studies of this drug in pregnant women.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by visiting www.mothertobaby.org/ongoing-study/asthma.

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

Levalbuterol Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments: The effects in the nursing infant are unknown.

In animal studies, racemic albuterol showed a potential for tumorigenicity. There are no controlled data for the use of this drug by nursing mothers.

See references

Further information

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