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Tolvaptan Pregnancy and Breastfeeding Warnings

Brand names: Jynarque, Samsca

Medically reviewed by Drugs.com. Last updated on Dec 12, 2023.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The use of this drug is not recommended during pregnancy. Some authorities consider it contraindicated.

US FDA pregnancy category: Not assigned

Risk Summary: Available data in pregnant women are insufficient to determine if there is a drug-associated risk of adverse developmental outcomes.

Comments: Women of childbearing potential should use adequate contraceptive measures during treatment with this drug.

See references

Tolvaptan Breastfeeding Warnings

Use is not recommended, and some authorities consider it contraindicated.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.

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

See also

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Samsca (tolvaptan). Otsuka American Pharmaceuticals Inc. 2009.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Product Information. Samsca (tolvaptan). Otsuka American Pharmaceuticals Inc. 2009.

Further information

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

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