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Sodium phenylbutyrate Pregnancy and Breastfeeding Warnings

Sodium phenylbutyrate is also known as: Buphenyl

Medically reviewed on July 16, 2018

Sodium phenylbutyrate Pregnancy Warnings

UK: Use is contraindicated during pregnancy.
US: Use during pregnancy only if clearly needed.

US FDA pregnancy category: C

Comments:
-Advise women of reproductive potential to use effective contraception.
-The effect of this drug on the fetus when administered to a pregnant woman and its effect on reproductive capacity are unknown.

Animal studies have shown reproductive toxicity; fertility studies have not been conducted. 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.

See references

Sodium phenylbutyrate Breastfeeding Warnings

UK: Use is contraindicated during breastfeeding.
US: Use with caution during breastfeeding.

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. Buphenyl (sodium phenylbutyrate)." Horizon Pharma USA Inc, Northbrook, IL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Buphenyl (sodium phenylbutyrate)." Horizon Pharma USA Inc, Northbrook, IL.
  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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