The Michigan Medicaid surveillance study does not reveal an association between cefadroxil and congenital defects. This report is a summary of information from two studies, one in which 99 of 104,000 pregnant women from 1980 to 1983, and one in which 722 of 229,000 pregnant women from 1985 to 1992 received cefadroxil. In the first study, eight total defects and one cardiovascular defect were observed (six and one were expected, respectively). In the second study, fewer total and cardiovascular defects were observed than expected. Cleft palate was not observed in either study.

Cefadroxil has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Cefadroxil should only be given during pregnancy when need has been clearly established.

Following a single 1 gram oral dose to six lactating women, peak milk cefadroxil levels were observed at six to seven hours, averaging 1.83 mcg per mL. These levels are low and are not expected to cause adverse effects in nursing infants.

Cefadroxil is excreted into human milk in small amounts. However, no adverse effects in nursing infants have been reported. Cefadroxil is considered compatible with breast-feeding by the American Academy of Pediatrics.