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Pheburane
Sodium Phenylbutyrate
$980.00
483mg · 1
BrandBranded medicine· By Medunik USA
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About Pheburane
Overview
Pheburane contains sodium phenylbutyrate, a nitrogen-binding medicine used for the long-term management of certain urea cycle disorders in adults and children, specifically those involving CPS, OTC or AS enzyme deficiencies. It is used alongside standard care, including dietary management. It helps the body remove waste nitrogen through the kidneys by converting it into a substance that can be passed in urine. It is not used to treat sudden episodes of high blood ammonia, which can be life-threatening and require urgent treatment.
What it treats
• Long-term management of urea cycle disorders caused by deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS) in adults and children, alongside standard care including dietary management. Not for treating acute hyperammonemia (a sudden rise in blood ammonia), which can be a life-threatening emergency.
Safety information
Side effects
Common side effects include missed periods or irregular menstrual cycles, decreased appetite, body odor, and an unpleasant taste or aversion to taste. Other reported side effects include abdominal pain, nausea, vomiting, constipation, headache, rash, weight gain and depression. Serious reported effects include irregular heartbeat, fainting, rectal bleeding, stomach or intestinal ulcers, inflammation of the pancreas, and blood disorders, including aplastic anemia, where the body does not make enough blood cells. Contact your doctor if you experience an irregular heartbeat, fainting, rectal bleeding, unusual bruising, or new or worsening swelling. Pheburane can also cause low blood potassium, which requires monitoring during treatment. Increased exposure to phenylacetate, a substance formed when the body breaks down Pheburane, may cause nervous system toxicity. Blood tests may also show changes in liver markers, blood cell counts and other blood chemistry values.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The label lists no formal contraindications. However, Pheburane should be avoided in people with hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Caution is needed in people with diabetes or conditions associated with fluid retention or swelling (edema). Total sodium exposure must be assessed. If new or worsening swelling develops, Pheburane must be stopped and appropriate treatment started. Phenylacetate, a breakdown product of Pheburane, may cause toxic effects on the nervous system. Symptoms require prescriber review. Pheburane may also lower blood potassium, so potassium levels should be monitored during treatment.
Interactions
Tell your doctor if you take valproic acid, haloperidol or corticosteroids. These medicines may raise blood ammonia levels, so close monitoring is needed. Probenecid may reduce the kidneys’ removal of substances formed when Pheburane is broken down, including phenylacetate and phenylacetylglutamine. Your doctor should monitor for possible harmful effects on the nervous system.
Using Pheburane
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place with the bottle tightly closed, away from direct light and moisture. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label PHEBURANE (SODIUM PHENYLBUTYRATE) PELLET PHEBURANE (SODIUM PHENYLBUTYRATE) KIT [MEDUNIK USA] (DailyMed, retrieved 19 September 2026).
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