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Tolvaptan Pregnancy and Breastfeeding Warnings

Tolvaptan is also known as: Jynarque, Samsca

Medically reviewed on June 5, 2018

Tolvaptan Pregnancy Warnings

In animal studies, cleft palate, brachymelia, microphthalmia, skeletal malformations, decreased fetal weight, delayed fetal ossification, and embryofetal death occurred. There are no controlled data in human pregnancy.

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.

UK: Contraindicated

US: Use during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

US FDA pregnancy category: C

Comments: Women of childbearing potential should use adequate contraceptive measures during tolvaptan use.

See references

Tolvaptan Breastfeeding Warnings

UK: Use is contraindicated.
US: Use is not recommended.

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

The effects in the nursing infant are unknown.

A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

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

References for breastfeeding information

  1. "Product Information. Samsca (tolvaptan)." Otsuka American Pharmaceuticals Inc, Rockville, MD.
  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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