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Isosorbide dinitrate Pregnancy and Breastfeeding Warnings

Isosorbide dinitrate is also known as: Dilatrate-SR, ISDN, IsoDitrate, Isochron, Isordil, Isordil Tembids, Isordil Titradose, Sorbitrate

Medically reviewed on March 9, 2017

Isosorbide dinitrate Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: C

Animal studies have revealed evidence of embryotoxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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

Isosorbide dinitrate Breastfeeding Warnings

Caution is recommended.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Isordil (isosorbide dinitrate)." 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

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Isordil (isosorbide dinitrate)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  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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