U.S. Food and Drug Administration's Pregnancy Category B by one manufacturer and category C by another source (Briggs et al, 1998).
See Drug Consult reference: "PREGNANCY RISK CATEGORIES".
There have been no published reports linking Simethicone with congenital defects. However, an unpublished surveillance study of 229,101 completed pregnancies identified 248 newborns exposed to Simethicone during the first trimester, in which 14 (5.6%) major birth defects were observed and 11 were expected. Of the 6 defect categories, only the cardiovascular defects suggested possible association with Simethicone; specific data for the individual categories were as follows (observed/expected): cardiovascular 6/2; oral clefts 0/0.5; spina bifida 0/0; Polydactyly 2/1; limb reduction defects 0/0.5; and hypospadias 1/0.5 (Briggs et al, 1998).