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Sodium benzoate / sodium phenylacetate Pregnancy and Breastfeeding Warnings

Sodium benzoate / sodium phenylacetate is also known as: Ammonul

Sodium benzoate / sodium phenylacetate Pregnancy Warnings

Animal studies revealed prenatal exposure of offspring to sodium phenylacetate produced lesions in layer 5 cortical pyramidal cells. However, specific animal reproduction and fertility impairment studies have not been conducted.

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.

This drug should be used by pregnant women only if clearly needed.

US FDA pregnancy category: C

Comments: It is unknown whether this drug can cause fetal harm or can affect reproduction capacity.

See references

Sodium benzoate / sodium phenylacetate 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. Ammonul (sodium benzoate-sodium phenylacetate)." Ucyclyd Pharma, Scottsdale, AZ.

References for breastfeeding information

  1. "Product Information. Ammonul (sodium benzoate-sodium phenylacetate)." Ucyclyd Pharma, Scottsdale, AZ.

Further information

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

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