It has been used off-label to treat nausea and vomiting in
pregnancy. Based on recent studies regarding the association between
Zofran use in early
pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy. There are also potential maternal risks associated with taking Zofran especially in pregnant women with electrolyte imbalance due to severe nausea and vomiting.