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Rasagiline Pregnancy and Breastfeeding Warnings

Rasagiline is also known as: Azilect

Medically reviewed on September 20, 2017

Rasagiline Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus.

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

Animal studies have revealed evidence of embryolethality when rasagiline was used in high doses in combination with levodopa/carbidopa. 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

Rasagiline Breastfeeding Warnings

Experimental data has shown that this drug inhibits prolactin secretion and may therefore inhibit lactation.

Use with caution

Excreted into human milk: Unknown

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. Azilect (rasagiline)." Teva Pharmaceuticals USA, North Wales, PA.

References for breastfeeding information

  1. "Product Information. Azilect (rasagiline)." Teva Pharmaceuticals USA, North Wales, PA.
  2. 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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