Albuterol

Pregnancy

The human pregnancy evidence is observational, and randomized trials of albuterol in pregnancy are absent. A US case-control analysis in the National Birth Defects Prevention Study included 28,481 birth-defect cases and 10,894 controls and assessed reported asthma medication use from one month before conception through the third month. The authors found that albuterol use was associated with cerebellar hypoplasia, cleft palate, cleft lip, longitudinal limb deficiency, and truncus arteriosus. Most birth defects studied were not associated with asthma medication use, and the authors said they could not rule out confounding by asthma or its severity; analyses of individual medication components had small numbers and imprecise estimates. MotherToBaby says limited data do not suggest an overall increase in birth defects with inhaled albuterol. A 2026 review concludes that available evidence does not establish a link between inhaled short-acting beta agonists and fetal malformations or other adverse pregnancy outcomes, while noting that reported cleft findings may be confounded by the underlying condition.

Breastfeeding

LactMed reports no published data on albuterol by mouth or inhaler during lactation and no relevant published infant levels or effects. It draws on terbutaline studies and expert guidance to describe very little expected milk transfer and acceptance of inhaled bronchodilators. A 1984 primary study measured terbutaline in milk and plasma from four nursing mothers taking oral tablets; infants were estimated to receive 0.2% to 0.7% of the mother's daily dose per kilogram, and no signs of beta-adrenoceptor stimulation were found. This is evidence about terbutaline, not direct evidence about albuterol. The NHS reports that salbutamol has been widely used while breastfeeding without reported infant side effects and that milk levels are likely very low. Direct albuterol milk-level and infant-outcome studies remain absent from these sources.

What was tested

The 2020 National Birth Defects Prevention Study was a multi-state case-control study using self-reported early-pregnancy asthma medication use and 52 specific birth-defect outcomes. It examined medication groups and individual components, including albuterol, but the authors noted small numbers and imprecise estimates for individual components. The 2026 pregnancy case report describes one patient with supratherapeutic inhaled salbutamol and salmeterol use at 37 weeks, not usual-dose albuterol use. The breastfeeding study measured the related medicine terbutaline in four mothers; it did not measure albuterol. No randomized pregnancy trial or direct human albuterol breastfeeding study was identified in the reviewed sources.