Benefit should outweigh risk.

US FDA pregnancy category: Not assigned.

Risk summary:
-No data available on use of this product in pregnant women to inform a drug-related risk.
-Animal studies have revealed evidence of adverse developmental outcomes and structural abnormalities with the use of albuterol and budesonide, respectively.
-Based on the findings in animals, albuterol, and budesonide (individual components of this product) may cause fetal harm when administered to a pregnant woman.

Comments:
-An asthma medications pregnancy exposure registry is available (https://mothertobaby.org/ongoing-study/asthma/).
-This product is not approved for the management of preterm labor.
-Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol.
-This product may harm a developing fetus.

In animal studies, albuterol administered during the period of organogenesis revealed evidence of adverse developmental outcomes (cleft palate in mice, delayed ossification in rabbits) at less than the maximum recommended human daily inhalation dose (MRHDID), enlargement of the frontal portion of the fetal fontanelles at approximately one third of the MRHDID on a mg/m2 basis, and cranioschisis at approximately 750 times the MRHDID in adults.

Budesonide administered by the subcutaneous route has been embryocidal, caused structural abnormalities, and reduced fetal weight in rats and rabbits at doses less than the MRHDID; however, these effects were not seen in rats that received inhaled doses approximately 2.5 times the MRHDID.

Women who have poorly, or moderately controlled asthma are more likely to have preeclampsia and prematurity, low birth weight, and neonates who are small for gestational age. Closely monitor pregnant women with asthma and medicate accordingly to maintain optimal asthma control. This product should be used during labor only if the benefit clearly outweighs the risk, as it is not approved for the management of pre-term labor.

An asthma medications pregnancy registry has been established. Physicians are encouraged to register patients, and pregnant women are encouraged to register themselves by calling 1-877-311-8972. For additional information: https://mothertobaby.org/ongoing-study/asthma

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription product drugs 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

In clinical studies, budesonide was detected in human milk following maternal inhalation, resulting in infant doses of approximately 0.3% to 1% of the maternal weight-adjusted dose and a milk-to-plasma ratio of approximately 0.5. A small study reported the presence of budesonide in plasma samples of five infants about 90 minutes after breastfeeding but at levels below quantifiable levels.

Safety has not been established. Benefit to mother should outweigh risk to the infant.

Excreted into human milk: Unknown (albuterol); Yes (budesonide)
Excreted into animal milk: Data not available (albuterol); Data not available (budesonide)

Comments:
-The effects of albuterol in the nursing infant are unknown. Plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, are likely to be correspondingly low.
-No adverse effects were observed in the nursing infant following the maternal use of inhaled budesonide.

See references