Sodium phenylbutyrate Side Effects

It is possible that some side effects of sodium phenylbutyrate may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sodium phenylbutyrate: oral powder, oral tablet, oral tablet enteric coated

As well as its needed effects, sodium phenylbutyrate may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sodium phenylbutyrate, check with your doctor immediately:

More common
  • Change in the frequency of breathing
  • lack of or irregular menstruation
  • lower back, side, or stomach pain
  • mood or mental changes
  • muscle pain or twitching
  • nausea or vomiting
  • nervousness or restlessness
  • swelling of the feet or lower legs
  • unpleasant taste
  • unusual tiredness or weakness
Less common
  • Chills
  • fever
  • joint pain
  • sore throat
  • unusual bleeding or bruising
Rare
  • Convulsions (seizures)
  • dizziness
  • dryness of the mouth
  • fast, slow, or irregular heartbeat
  • increased blood pressure
  • increased thirst
  • irritability
  • muscle cramps
  • rectal bleeding
  • swelling of the face
  • unusual weight gain
  • weak pulse

Some sodium phenylbutyrate side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Changes in taste
  • decreased appetite
  • strong body odor
Rare
  • Abdominal or stomach pain
  • constipation
  • fainting
  • headache
  • mental depression
  • skin rash

For Healthcare Professionals

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

Hematologic

Frequency not reported: Aplastic anemia, ecchymoses[Ref]

Cardiovascular

Frequency not reported: Arrhythmia, edema[Ref]

Dermatologic

Frequency not reported: Rash[Ref]

Gastrointestinal

Frequency not reported: Abdominal pain, gastritis, nausea and vomiting; constipation, rectal bleeding, peptic ulcer disease, pancreatitis[Ref]

Genitourinary

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

Metabolic

Common (1% to 10%): Decreased appetite (4%), body odor (3%), bad taste or taste aversion (3%)
Frequency not reported: Weight gain[Ref]

Nervous system

Frequency not reported: Headache, syncope, neurotoxicity (manifested predominantly with somnolence, fatigue, and lightheadedness; and less frequently with headache, dysgeusia, hypoacusis, disorientation, impaired memory, and exacerbation of a pre-existing neuropathy)[Ref]

Psychiatric

Frequency not reported: Depression[Ref]

Renal

Frequency not reported: Renal tubular acidosis[Ref]

Other

Laboratory Adverse Event in Patients with urea cycle disorders (UCDs):
Very common (10% or more): Acidosis (14%), hypoalbuminemia (11%)
Common (1% to 10%): Anemia (9%), alkalosis (7%), hyperchloremia (7%), hypophosphatemia (6%), increased alkaline phosphatase (6%), increased liver transaminases (4%), leukopenia (4%), leukocytosis (4%), decreased total protein (3%), thrombocytopenia (3%), hyperuricemia (2%), hyperphosphatemia (2%), hypernatremia (1%), hypokalemia (1%), hyperbilirubinemia (1%), thrombocytosis (1%)

References

1. "Product Information. Buphenyl (sodium phenylbutyrate)." Ucyclyd Pharma, Hunt Valley, MD.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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