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Mineral oil Pregnancy and Breastfeeding Warnings

Mineral oil is also known as: Fleet Mineral Oil Enema, Kondremul, Kondremul Plain, Liqui Doss, Milkinol, Muri-Lube

Medically reviewed by Drugs.com. Last updated on Sep 21, 2020.

Mineral oil Pregnancy Warnings

Animal studies have not been reported. There are no controlled data in human pregnancy.

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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: Not formally assigned to a pregnancy category. This class of drugs is generally exempt from pregnancy classification.
US FDA pregnancy category: Not formally assigned to a pregnancy category.

See references

Mineral oil Breastfeeding Warnings

Use is not recommended and 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

Comments:
-The effects in the nursing infant are unknown.
-Some experts state that repeated use should be avoided due to decreased absorption of fat-soluble vitamins.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Kondremul (mineral oil)." Bristol-Myers Squibb, Princeton, NJ.
  4. "Product Information. Fleet Mineral Oil Enema (mineral oil)." Fleet, Lynchburg, VA.
  5. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):

References for breastfeeding information

  1. "Product Information. Kondremul (mineral oil)." Bristol-Myers Squibb, Princeton, NJ.
  2. "Product Information. Fleet Mineral Oil Enema (mineral oil)." Fleet, Lynchburg, VA.
  3. National Library of Medicine (US) "Drugs and Lactation Database (LactMed) Available from: URL: https://www.ncbi.nlm.nih.gov/books/NBK501922/" (2006):
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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