Rifabutin Pregnancy and Breastfeeding Warnings

Brand names: Mycobutin

Medically reviewed by Drugs.com. Last updated on Feb 17, 2025.

Rifabutin Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-This drug may interact with oral contraceptives; patients should be advised to use additional or alternative (e.g., nonhormonal) methods of contraception.
-Rifampin has been associated with serious vitamin K deficiency in mother and neonate (leading to hemorrhagic disturbances) when used during the late stages of pregnancy.
---According to some authorities: This should be considered if the physician deems the benefit of therapy outweighs the risk and decides to use rifabutin during pregnancy.

Animal studies have failed to reveal evidence of teratogenicity but have revealed evidence of increased fetal skeletal variants and anomalies. In rats, decreased fetal viability and increased fetal skeletal variants were observed at exposures about 6 times and about equal to the recommended human daily dose based on body surface area (BSA) comparisons, respectively. In rabbits, maternal toxicity and increased fetal skeletal anomalies were observed at exposures about 5 times the recommended human daily dose based on BSA comparisons. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Rifabutin Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Yes

Comments:
-The amount of this drug in milk is insufficient to treat tuberculosis in the breastfed infant.
-The US CDC and other experts state that breastfeeding should not be discouraged in patients taking this drug.
---Infants should be monitored for signs of liver toxicity.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions in nursing infants.
-Breast milk may be colored brown-orange.
-According to some authorities: As a precaution, this drug should not be administered to patients breastfeeding children.

See references

Further information

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

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