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Cilostazol Pregnancy and Breastfeeding Warnings

Cilostazol is also known as: Pletal

Medically reviewed by Drugs.com. Last updated on Sep 29, 2018.

Cilostazol Pregnancy Warnings

Use is contraindicated per some authorities.

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

Animal studies have revealed evidence of teratogenicity at doses greater than 5 times the maximum recommended human dose (MRHD) on a body surface area basis. 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

Cilostazol 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; use is contraindicated per some authorities.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Pletal (cilostazol)." Otsuka American Pharmaceuticals, Rockville, MD.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Pletal (cilostazol)." Otsuka American Pharmaceuticals, Rockville, MD.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. 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.

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