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.
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
- (2005) "Product Information. Ammonul (sodium benzoate-sodium phenylacetate)." Ucyclyd Pharma
References for breastfeeding information
- (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.