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Rifaximin Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Mar 16, 2023.

Rifaximin is also known as: Xifaxan

Rifaximin Pregnancy Warnings

According to some authorities: Use is not recommended during pregnancy or in women of childbearing potential not using contraception.

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

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk; based on animal data, this drug may cause fetal harm.

-Pregnant patients should be apprised of the potential harm to the fetus.
-Additional contraceptive precautions recommended; local protocol should be consulted.

Animal studies have revealed evidence of teratogenicity at doses about 0.9 to 5 times (rats) and 0.7 to 33 times (rabbits) the recommended human doses of 600 to 1650 mg/day; effects included cleft palate, agnathia, jaw shortening, hemorrhage, eye partially open, small eyes, brachygnathia, incomplete ossification, and increased thoracolumbar vertebrae. Ocular malformations in rats and rabbits observed at doses that caused reduced maternal body weight gain. 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.

See references

Rifaximin Breastfeeding Warnings

LactMed: An alternate agent may be preferred, especially while breastfeeding newborn or preterm infants.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

-The development and health benefits of human milk feeding should be considered.
-Potential side effects in the human milk fed child due to the drug or the mother's underlying condition should be considered.
-This drug is poorly absorbed orally and is unlikely to reach breast milk or bloodstream of the nursing infant.
-The effects in the nursing infant are unknown; adverse effects are unlikely.

See references

References for pregnancy information

  1. "Product Information. Xifaxan (rifaximin)." Salix Pharmaceuticals (2004):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy." (2007):
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Xifaxan (rifaximin)." Salix Pharmaceuticals (2004):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. National Library of Medicine (US) "Drugs and Lactation Database (LactMed)" (2019):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.