Medicis | Buphenyl (Medication)
Buphenyl/sodium phenylbutyrate is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. Buphenyl must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. ...
The following side effects may occur:abdominal pain, gastritis, nausea and vomiting; constipation, rectal bleeding, peptic ulcer disease, and pancreatitis each occurred in one patient. Hematologic:aplastic anemia and ecchymoses each occurred in one patient. Cardiovascular:arrhythmia and edema each occurred in one patient. Renal:renal tubular acidosis. Psychiatric:depression. Skin:rash.
In female patients, the most common clinical adverse event reported was amenorrhea/menstrual dysfunction (irregular menstrual cycles). ...
It is not known whether Buphenyl can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Buphenyl should not be administered to patients with known hypersensitivity to sodium phenylbutyrate or any component of this preparation. Carcinogenicity, mutagenicity, and fertility studies of sodium phenylbutyrate have not been conducted. ...