Animal studies did not show teratogenicity; slightly decreased fertility was seen at doses above the maximum human dose. Limited case reports did not report any adverse fetal or neonatal outcomes. This drug crosses the placenta and was measurable in the serum of the infant. A 1999 report concluded that pregnant women should be managed the same way as nonpregnant patients for acetaminophen overdose, and that acetylcysteine therapy was protective to both mother and fetus. There are no controlled data in human pregnancy

Use is not recommended unless clearly needed. AU TGA pregnancy category: B2 US FDA pregnancy category: B

Animal studies did not show adverse effects during lactation. It is unknown in this drug or its metabolites are excreted in milk. Based on the pharmacokinetics, it should be nearly cleared 30 hours after administration.

Use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: May consider resuming nursing 30 hours after the last administration.