Cefaclor Pregnancy and Breastfeeding Warnings

Brand names: Ceclor, Ceclor CD, Ceclor Pulvules, Raniclor

Medically reviewed by Drugs.com. Last updated on Dec 11, 2023.

Cefaclor Pregnancy Warnings

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

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Animal studies have failed to reveal evidence of (embryolethality, embryotoxicity, fetolethality, fetotoxicity, fetal harm, impaired fertility, teratogenicity, embryofetal toxicity); however, there was a slight increase in minor skeletal malformation when animal models were given high doses (500 mg/kg). 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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Cefaclor Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-The American Academy of Pediatrics considers other cephalosporins (e.g., cefadroxil, cefazolin) as compatible with breastfeeding.
-Maternal doses of cephalosporins have resulted in reports of neonatal diarrhea and thrush.

Small amounts of up to 0.21 mcg/mL were detected in breast milk up to 5 hours after administration of single, 500 mg oral doses.

See references

Further information

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