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Sodium benzoate / sodium phenylacetate Pregnancy and Breastfeeding Warnings

Brand names: Ammonul

Sodium benzoate / sodium phenylacetate Pregnancy Warnings

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.

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.

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

See also

References for pregnancy information

  1. (2005) "Product Information. Ammonul (sodium benzoate-sodium phenylacetate)." Ucyclyd Pharma

References for breastfeeding information

  1. (2005) "Product Information. Ammonul (sodium benzoate-sodium phenylacetate)." Ucyclyd Pharma

Further information

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

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