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Fenofibrate Pregnancy and Breastfeeding Warnings

Fenofibrate is also known as: Antara, Fenoglide, Lipidil EZ, Lipidil Micro, Lipidil Supra, Lipofen, Lofibra, TriCor, Triglide

Medically reviewed on March 31, 2017

Fenofibrate Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; according to some experts, use is not recommended.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Animal studies have revealed evidence of embryofetal toxicity and fetal abnormalities at higher doses that also produced maternal toxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Fenofibrate Breastfeeding Warnings

Animal studies in rats during lactation revealed evidence of decreased survival and weight gain in offspring.

Use should be avoided.

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

Comments: This drug should not be used during breastfeeding due to the potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism.

See references

References for pregnancy information

  1. "Product Information. Triglide (fenofibrate)." Sciele Pharma Inc, Atlanta, GA.
  2. "Product Information. Fenoglide (fenofibrate)." Santarus Inc, San Diego, CA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Lofibra (fenofibrate)." Teva Pharmaceuticals (formerly Gate Pharmaceuticals), Sellersville, PA.
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. Tricor (fenofibrate)." Abbott Pharmaceutical, Abbott Park, IL.
  7. "Product Information. Antara (fenofibrate)." Lupin Pharmaceuticals Inc, Baltimore, MD.
  8. "Product Information. Fenofibrate (fenofibrate)." Mylan Pharmaceuticals Inc, Morgantown, WV.
  9. "Product Information. Lipofen (fenofibrate)." Kowa Pharmaceuticals America (formerly ProEthic), Montgomery, AL.

References for breastfeeding information

  1. "Product Information. Fenoglide (fenofibrate)." Santarus Inc, San Diego, CA.
  2. "Product Information. Lofibra (fenofibrate)." Teva Pharmaceuticals (formerly Gate Pharmaceuticals), Sellersville, PA.
  3. "Product Information. Fenofibrate (fenofibrate)." Mylan Pharmaceuticals Inc, Morgantown, WV.
  4. "Product Information. Lipofen (fenofibrate)." Kowa Pharmaceuticals America (formerly ProEthic), Montgomery, AL.
  5. "Product Information. Triglide (fenofibrate)." Sciele Pharma Inc, Atlanta, GA.
  6. "Product Information. Antara (fenofibrate)." Lupin Pharmaceuticals Inc, Baltimore, MD.
  7. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  8. Cerner Multum, Inc. "Australian Product Information." O 0
  9. "Product Information. Tricor (fenofibrate)." Abbott Pharmaceutical, Abbott Park, IL.

Further information

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

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