Animal studies show that rat offspring exhibit alterations in behavior and brain development, including decreased cellular proliferation and differentiation, when this drug was administered subcutaneously during the late stage of pregnancy and lactation period.
This drug crosses the placenta. Umbilical blood levels of this drug were found in the range from 11% to 48% of the maternal blood levels, after single dose IV administration.
Animal embryofetal developmental studies show no teratogenic effects in offspring of pregnant rats and rabbits receiving this drug. There are no controlled data in human pregnancy.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

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

Treatment of Premature Labor:
-In some countries, the IV infusion is approved to arrest labor between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy.
-According to some authorities, the IV infusion should be administered with caution during the first trimester of pregnancy.

AU TGA pregnancy category: A
US FDA pregnancy category: C

Comments:
-In some countries, the subcutaneous solution has not been approved for and should not be used for prolonged tocolysis (beyond 48 to 72 hours). It should not be used for maintenance tocolysis in the outpatient or home setting.
-Serious adverse reactions such, increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, myocardial ischemia, and death have been reported in pregnant women after taking this drug.
-Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration.
-Maintenance therapy for asthma and other pulmonary diseases: Use with caution at the end of pregnancy because of the potential tocolytic effect.
-Labor and delivery: The use for relief of bronchospasm during labor should be restricted to patients in whom the benefits clearly outweigh the risk.

See references

Although this drug is secreted into breast milk and milk concentrations are approximately those in maternal plasma, two individual case studies indicate that the infant is likely to receive 0.2-0.7% of the maternal dose, depending on the time of feeding in relation to administration of the drug. No signs of beta-adrenoceptor stimulation were observed.

Use only if the expected benefit to mother outweigh risk to the infant.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Transient hypoglycemia has been reported in newborn preterm infants after maternal beta2-agonist treatment.

See references