Sodium Phenylbutyrate

Breast Feeding; Lactation; Milk, Human; Urea Cycle Disorders

FDA approved drugs -> Active ingredient

EMA approved medicines: Human medicine

EMA approved medicines: Human medicine

FDA approved drugs -> Active ingredient

This chemical does not meet GHS hazard criteria for 2.3% (1 of 44) of reports.

Warning

H319 (93.2%): Causes serious eye irritation [Warning Serious eye damage/eye irritation]

P264+P265, P280, P305+P351+P338, and P337+P317 (click each P-code to see the statement)

Aggregated GHS information provided per 44 reports by companies from 6 notifications to the ECHA C&L Inventory.

While the urea cycle disorders are caused by deficiencies of hepatic enzymes responsible for the elimination of nitrogen, patients generally present with hyperammonemia without other features or biochemical evidence of hepatic injury. Thus, serum aminotransferase, alkaline phosphatase and bilirubin levels are generally normal or only mildly elevated. Newborns presenting with hyperammonemia may have hepatomegaly but other, non-urea cycle, liver function is normal as is hepatic histology. Phenylbutyrate can help to lower ammonia levels acutely and manage to keep them in the normal or near normal range, but generally does not affect other liver functions. In open label studies, a small proportion of patients (particularly with ornithine transcarbamylase [OTC] deficiency) have had ALT or AST elevations, but these have generally been attributed to the underlying condition or its complications. Phenylbutyrate has not been linked to instances of clinically apparent liver injury with jaundice.

Drug Induced Liver Injury Rank (DILIrank 2.0)

Sodium phenylbutyrate

Ambiguous-DILI-concern

4

Adverse reactions

DOI:10.1016/j.drudis.2016.02.015

A - Alimentary tract and metabolism

QA - Alimentary tract and metabolism

SODIUM PHENYLBUTYRATE

Ammonium Ion Binding Activity [MoA]; Nitrogen Binding Agent [EPC]

SODIUM PHENYLBUTYRATE TABLETS, 500 MG

Ammonium Ion Binding Activity [MoA]; Nitrogen Binding Agent [EPC]