Use in Pregnancy: Pregnancy Category D: 5-FU may cause fetal harm when administered to pregnant women. Although it is not known whether 5-FU crosses the human placenta, it has been shown to cross the placenta and enter fetal circulation in rats. In monkeys, doses greater than 40 mg/kg resulted in abortion of all embryos exposed to the drug. Although there is no evidence to date of teratogenicity caused by 5-FU in humans, other drugs that inhibit DNA synthesis (e.g., methotrexate) have been reported to be teratogenic in humans; in addition, drugs that inhibit DNA, RNA and protein synthesis such as 5-FU may have adverse effects on perinatal and postnatal development. 5-FU should not be used in pregnancy.
Use in Lactation: It is not known whether 5-FU is distributed into milk. Because 5-FU inhibits DNA, RNA and protein synthesis, it is recommended that women do not breastfeed an infant while receiving the drug.