Animal studies have failed to reveal evidence of fetotoxicity, fetal harm, or teratogenicity at doses up to 7.5 times the maximum recommended human dose; however, there was increased incidence of abortion at levels reaching maternal toxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk Summary: Malformative risk with use of this drug in pregnant women is unlikely.

See references

Caution is recommended.

Excreted into human milk: Yes

Comments:
-The American Academy of Pediatrics considers this drug as compatible with breastfeeding.
-Maternal doses of cephalosporins have resulted in reports of neonatal diarrhea and thrush.
-Some experts state that patients should consider alternative feeding arrangements for infants.

See references