Sodium Phenylbutyrate Side Effects

Medically reviewed by Drugs.com. Last updated on May 20, 2024.

Applies to sodium phenylbutyrate: oral packet, oral pellet, oral powder, oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause nervous system problems. Check with your doctor right away if you have confusion, headache, lightheadedness, nausea, sleepiness, tiredness, or vomiting.

In case of emergency—There may be a time when you need emergency help for a problem caused by your urea cycle disorders. You need to be prepared for these emergencies. It is a good idea to wear a Medic Alert tag at all times. Also, carry an ID card in your wallet or purse that says you have this disease and a list of all of your medicines.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects

Along with its needed effects, sodium phenylbutyrate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sodium phenylbutyrate:

Other side effects

Some side effects of sodium phenylbutyrate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to sodium phenylbutyrate: oral pellet, oral powder for reconstitution, oral tablet.

General adverse events

Causality of adverse effects is sometimes difficult to determine because they may result from either the underlying disease, the patient's restricted diet, intercurrent illness, or the drug itself.^[Ref]

Endocrine

• Very common (10% or more): Amenorrhea/menstrual dysfunction (23%)^[Ref]

Metabolic

• Very common (10% or more): Acidosis (14%), hypoalbuminemia (11%)
• Common (1% to 10%): Alkalosis, decreased appetite, hyperchloremia, hypophosphatemia, decreased total protein, hyperuricemia, hyperphosphatemia, hypernatremia, hypokalemia, increased weight^[Ref]

Cardiovascular

• Common (1% to 10%): Edema
• Uncommon (0.1% to 1%): Arrhythmia^[Ref]

Dermatologic

• Common (1% to 10%): Rash, body odor^[Ref]

Gastrointestinal

• Common (1% to 10%): Abdominal pain, nausea, vomiting, constipation, dysgeusia
• Uncommon (0.1% to 1%): Pancreatitis, rectal bleeding/hemorrhage, peptic ulcer, gastritis^[Ref]

Hematologic

• Common (1% to 10%): Anemia, leukopenia, leukocytosis, thrombocytopenia, thrombocytosis
• Uncommon (0.1% to 1%): Aplastic anemia, ecchymosis^[Ref]

Hepatic

• Common (1% to 10%): Increased alkaline phosphatase, increased liver transaminases, hyperbilirubinemia^[Ref]

Nervous system

• Common (1% to 10%): Syncope, headache, bad taste/taste aversion
• Frequency not reported: Somnolence, fatigue, lightheadedness, hypoacusis, disorientation, impaired memory, exacerbation of preexisting neuropathy^[Ref]

Psychiatric

• Common (1% to 10%): Depression, irritability^[Ref]

Renal

• Common (1% to 10%): Renal tubular acidosis^[Ref]

See also:

Further information

Sodium phenylbutyrate side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer