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.

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.

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

US FDA pregnancy category: C

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).

See references

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