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.
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 also
References for pregnancy information
- "Product Information. Ammonul (sodium benzoate-sodium phenylacetate)." Ucyclyd Pharma (2005):
References for breastfeeding information
- "Product Information. Ammonul (sodium benzoate-sodium phenylacetate)." Ucyclyd Pharma (2005):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.