Buphenyl Oral Tablet 500Mg Drug Medication Dosage Information
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Buphenyl: Oral tablet (500mg)

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What is this Medicine?

SODIUM PHENYLBUTYRATE (sow dee um fen il bue ti rate) is used to manage the amount of ammonia in the blood of patients with urea cycle disorders. This medicine is not a cure.

In-Depth Information
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Buphenyl 500mg Tablet

NDC: 625920496
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Carbamoyl Phosphate Synthetase (CPS) Deficiency, Ornithine Transcarbamoylase (OTC) Deficiency, Argininosuccinic Acid Syntherase (AAS) Deficiency

Storage Information
Store at room temperature (between 59 to 86 degrees F)
Buphenyl 500mg Tablet

Reported Side Effects for Buphenyl 500mg Tablet

Upset Stomach Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Skin Rash Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Stomach Ulcer Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Bruise Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Abnormal Heart Rhythm Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Vomiting Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Fainting Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Inflamed Pancreas Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Bleeding Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Stomach Pain Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Kidney Dysfunction Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Aplastic Anemia Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Constipation Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Depression Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Swelling Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Inflamed Stomach Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Headache Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Low Potassium Levels Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
High Platelet Count Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
High Bilirubin Level Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
High Sodium Levels Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
High Uric Acid Level Incidence:
2.0%*
Severity: MODERATE
Onset: DELAYED
High Phosphate Levels Incidence:
2.0%*
Severity: MODERATE
Onset: DELAYED
Low Platelet Count Incidence:
3.0%*
Severity: MODERATE
Onset: DELAYED
Metallic Taste Incidence:
3.0%*
Severity: MILD
Onset: EARLY
Drug-induced Body Odor Incidence:
3.0%*
Severity: MILD
Onset: DELAYED
Elevated Hepatic Enzymes Incidence:
4.0-6.0%*
Severity: MODERATE
Onset: DELAYED
Low White Blood Cell Counts Incidence:
4.0%*
Severity: MODERATE
Onset: DELAYED
High White Blood Cells Incidence:
4.0%*
Severity: MILD
Onset: DELAYED
Low Phosphate Level Incidence:
6.0%*
Severity: MODERATE
Onset: DELAYED
High Chloride Level Incidence:
7.0%*
Severity: MODERATE
Onset: DELAYED
Electrolyte Imbalance Incidence:
7.0%*
Severity: MODERATE
Onset: DELAYED
Anemia Incidence:
9.0%*
Severity: MODERATE
Onset: DELAYED
Low Albumin In Blood Incidence:
11.0%*
Severity: MODERATE
Onset: DELAYED
Electrolyte Imbalance Incidence:
14.0%*
Severity: MODERATE
Onset: DELAYED
Irregular Periods Incidence:
23.0%*
Severity: MILD
Onset: DELAYED
No Menstrual Periods Incidence:
23.0%*
Severity: MILD
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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