Animal studies have not been conducted. During labor and delivery, this drug is utilized after delivery to assist involution and decrease hemorrhage. Under full obstetric supervision, this drug may be given in the second stage of labor following delivery of the anterior shoulder. There are no controlled data in human pregnancy.

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.

Use is contraindicated

US FDA pregnancy category: C

Comments: This drug is contraindicated during pregnancy because of its uterotonic effects.

See references

Use of this drug during the colostral phase of lactation is not expected to transfer appreciable amounts of drug to the breastfed infant. According to the manufacturer, there are isolated reports of adverse effects in breast-fed infants whose mothers received this drug for several days including elevated blood pressure, bradycardia, tachycardia, vomiting, diarrhea, restlessness, or clonic cramps. A case-control study has shown a lack of infant side effects. Other studies have shown decreased serum prolactin, milk production, and duration of lactation, especially when used in the immediate postpartum period (effects appear dose-related and more impactful with injected doses than oral). A short course immediately postpartum does not appear to have a detrimental effect on lactation, however, longer courses are best avoided in mothers who wish to breastfeed. If adverse reactions, such as tachycardia, vomiting, diarrhea and agitation are observed in a breastfed infant, this drug should be discontinued.

Breastfeeding is not recommended during use of this drug

Excreted into human milk: Yes

Comments:
-Breastfeeding should be avoided for 12 hours following last dose; milk secreted during this period should be discarded.

See references