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Disulfiram Pregnancy and Breastfeeding Warnings

Disulfiram is also known as: Antabuse

Medically reviewed on March 13, 2018

Disulfiram Pregnancy Warnings

AU: Contraindicated
UK, US: Not advised (the risk/benefit ratio in assessing adverse effects of alcoholism in pregnancy should be taken into account)

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

There have been rare reports of congenital abnormalities in infants whose mothers have received this drug in conjunction with other medicines.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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

Disulfiram 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.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Antabuse (disulfiram)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

References for breastfeeding information

  1. "Product Information. Antabuse (disulfiram)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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