Drug/Small Molecule:
sodium benzoate

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PharmGKB gathers information regarding PGx on FDA drug labels from the FDA's "Table of Pharmacogenomic Biomarkers in Drug Labels", and from FDA-approved FDA and EMA-approved (European Medicines Agency) EMA labels brought to our attention. Excerpts from the label and downloadable highlighted label PDFs are manually curated by PharmGKB.

Please note that some drugs may have been removed from or added to the FDA's "Table of Pharmacogenomic Biomarkers in Drug Labels" without our knowledge. We periodically check the table for additions to this table and update PharmGKB accordingly.

There is currently no such list for European drug labels - we are working with the EMA to establish a list of European Public Assessment Reports (EPAR)s that contain PGx information. We are constructing this list by initially searching for drugs for which we have PGx-containing FDA drug labels - of these 44 EMA EPARs were identified and are being curated for pgx information.

We welcome any information regarding drug labels containing PGx information approved by the FDA, EMA or other Medicine Agencies around the world - please contact feedback.


last updated 12/13/2013

FDA Label for phenylacetic acid, sodium benzoate and ARG1, ASL, ASS1, CPS1, NAGS, OTC

Informative PGx

Summary

Sodium Phenylacetate and Sodium Benzoate provides an alternate vehicle to urea for waste nitrogen excretion in patients with urea cycle disorders. Urea cycle disorders may be caused by mutations in the genes NAGS, CPS1, OTC, ASS1, ASL and ARG1. This drug-biomarker pair was previously in the FDA's "Table of Pharmacogenomic Biomarkers in Drug Labels" but has subsequently been removed.

Annotation

Sodium Phenylacetate and Sodium Benzoate provides an alternate vehicle to urea for waste nitrogen excretion in patients with urea cycle disorders. Urea cycle disorders may be caused by mutations in the genes NAGS, CPS1, OTC, ASS1, ASL and ARG1. This drug-biomarker pair was previously in the FDA's "Table of Pharmacogenomic Biomarkers in Drug Labels" but has subsequently been removed.

Excerpt from the Sodium Phenylacetate and Sodium Benzoate (Ammonul) drug label:

AMMONUL is a nitrogen binding agent indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.

Urea cycle disorders can result from decreased activity of any of the following enzymes: N-acetylglutamate synthetase (NAGS), carbamyl phosphate synthetase (CPS), argininosuccinate synthetase (ASS), ornithine transcarbamylase (OTC), argininosuccinate lyase (ASL), or arginase (ARG).

Sodium phenylacetate and sodium benzoate are metabolically active compounds that can serve as alternatives to urea for the excretion of waste nitrogen. Figure 2 is a schematic illustrating how the components of AMMONUL, phenylacetate and benzoate, provide an alternative pathway for nitrogen disposal in patients without a fully functioning urea cycle.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the sodium Phenylacetate and Sodium Benzoate (Ammonul) drug label.

*Disclaimer: The contents of this page have not been endorsed by the FDA and are the sole responsibility of PharmGKB.

Full label available at DailyMed

Genes and/or phenotypes found in this label

  • ARG1
    • Clinical pharmacology section, other
    • source: FDA Label
  • ASL
    • Clinical pharmacology section, other
    • source: FDA Label
  • ASS1
    • Clinical pharmacology section, other
    • source: FDA Label
  • CPS1
    • Clinical pharmacology section, other
    • source: FDA Label
  • NAGS
    • Clinical pharmacology section, other
    • source: FDA Label
  • OTC
    • Clinical pharmacology section, other
    • source: FDA Label

Disclaimer: The PharmGKB's clinical annotations reflect expert consensus based on clinical evidence and peer-reviewed literature available at the time they are written and are intended only to assist clinicians in decision-making and to identify questions for further research. New evidence may have emerged since the time an annotation was submitted to the PharmGKB. The annotations are limited in scope and are not applicable to interventions or diseases that are not specifically identified.

The annotations do not account for individual variations among patients, and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It remains the responsibility of the health-care provider to determine the best course of treatment for a patient. Adherence to any guideline is voluntary, with the ultimate determination regarding its application to be made solely by the clinician and the patient. PharmGKB assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of the PharmGKB clinical annotations, or for any errors or omissions.

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This is a non-comprehensive list of genetic tests with pharmacogenetics relevance, typically submitted by the manufacturer and manually curated by PharmGKB. The information listed is provided for educational purposes only and does not constitute an endorsement of any listed test or manufacturer.

A more complete listing of genetic tests is found at the Genetic Testing Registry (GTR).

PGx Test Variants Assayed Gene?

Overview

Generic Names
Trade Names
  • Ucephan
Brand Mixture Names

PharmGKB Accession Id:
PA451374

Other Vocabularies

Information pulled from DrugBank has not been reviewed by PharmGKB.

Chemical Properties

Isomeric SMILES

c1ccc(cc1)C(=O)[O-].[Na+]

Source: Drug Bank

Genes that are associated with this drug in PharmGKB's database based on (1) variant annotations, (2) literature review, (3) pathways or (4) information automatically retrieved from DrugBank, depending on the "evidence" and "source" listed below.

Curated Information ?

EvidenceGene
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
ARG1
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
ASL
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
ASS1
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
CPS1
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
NAGS
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
OTC
No related drugs are available.

Relationships from National Drug File - Reference Terminology (NDF-RT)

May Treat
Contraindicated With

Clinical Trials

These are trials that mention sodium benzoate and are related to either pharmacogenetics or pharmacogenomics.

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Sources for PharmGKB drug information: DrugBank, Open Eye Scientific Software.