Pregnancy

There are no adequate and well-controlled studies

Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Animal data

Animal reproduction studies with mice and rats using oral doses of cephalexin that are 0.6- and 1.2-times the maximum recommended human dose (MRHD) based on body surface area during organogenesis revealed no evidence of harm to the fetus; estimated background risk of major birth defects and miscarriage for indicated population is unknown

Lactation

Data from a published clinical lactation study reports that cephalexin is present in human milk; relative infant dose (RID) is considered to be <1% of maternal weight adjusted dose; there are no data on effects of cephalexin on breastfed child or on milk production

Development of health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.