Buphenyl Side Effects

Please note - some side effects for Buphenyl may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Buphenyl - for the Consumer

Buphenyl

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Buphenyl:

Bad taste in mouth; body odor; decreased appetite; absent or irregular menstrual periods.

Seek medical attention right away if any of these SEVERE side effects occur when using Buphenyl:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing; disorientation; headache; lightheadedness; memory problems; sleepiness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Buphenyl Powder

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Buphenyl Powder:

Bad taste in the mouth; body odor; decreased appetite; absent or irregular menstrual periods.

Seek medical attention right away if any of these SEVERE side effects occur when using Buphenyl Powder:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing; disorientation; headache; lightheadedness; memory problems; sleepiness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Buphenyl Side Effects - for the Professional

Buphenyl

The assessment of clinical adverse events came from 206 patients treated with sodium phenylbutyrate. Adverse events (both clinical and laboratory) were not collected systematically in these patients, but were obtained from patient-visit reports by the 65 co-investigators. Causality of adverse effects is sometimes difficult to determine in this patient population because they may result from either the underlying disease, the patient's restricted diet, intercurrent illness, or Buphenyl®. Furthermore, the rates may be under-estimated because they were reported primarily by parent or guardian and not the patient.

Clinical Adverse Events

In female patients, the most common clinical adverse event reported was amenorrhea/menstrual dysfunction (irregular menstrual cycles), which occurred in 23% of the menstruating patients.

Decreased appetite occurred in 4% of all patients. Body odor (probably caused by the metabolite, phenylacetate) and bad taste or taste aversion were each reported in 3% of patients.

Other adverse events reported in 2% or fewer patients were:

Gastrointestinal: 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

Miscellaneous: headache, syncope, and weight gain

Neurotoxicity was reported in cancer patients receiving intravenous phenylacetate, 250–300 mg/kg/day for 14 days, repeated at 4-week intervals. Manifestations were predominately somnolence, fatigue, and lightheadedness; with less frequent headache, dysgeusia, hypoacusis, disorientation, impaired memory, and exacerbation of a pre-existing neuropathy. These adverse events were mainly mild in severity. The acute onset and reversibility when the phenylacetate infusion was discontinued suggest a drug effect.

Laboratory Adverse Events

In patients with urea cycle disorders, the frequency of laboratory adverse events by body system were:

Metabolic: acidosis (14%), alkalosis and hyperchloremia (each 7%), hypophosphatemia (6%), hyperuricemia and hyperphosphatemia (each 2%), and hypernatremia and hypokalemia (each 1%).

Nutritional: hypoalbuminemia (11%) and decreased total protein (3%).

Hepatic: increased alkaline phosphatase (6%), increased liver transaminases (4%), and hyperbilirubinemia (1%).

Hematologic: anemia (9%), leukopenia and leukocytosis (each 4%), thrombocytopenia (3%), and thrombocytosis (1%).

The clinician is advised to routinely perform urinalysis, blood chemistry profiles, and hematologic tests.

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Side Effects by Body System - for Healthcare Professionals

Hematologic

Hematologic side effects have included aplastic anemia and ecchymoses. Anemia (9%), leukopenia and leukocytosis (each 4%), thrombocytopenia (3%), and thrombocytosis (1%) have also been reported.

Cardiovascular

Cardiovascular side effects have included syncope, arrhythmia and edema.

Dermatologic

Dermatologic side effects have included rash.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, gastritis, nausea and vomiting; constipation, rectal bleeding, peptic ulcer disease, pancreatitis, and bad taste or taste aversion.

General

General side effects have included body odor (probably caused by the metabolite, phenylacetate), bad taste or taste aversion, headache, and weight gain.

Genitourinary

Genitourinary side effects have included amenorrhea and menstrual dysfunction.

Hepatic

Hepatic side effects have included increased alkaline phosphatase (6%), increased liver transaminases (4%), and hyperbilirubinemia (1%).

Metabolic

Metabolic side effects have included acidosis (14%), hypoalbuminemia (11%), alkalosis and hyperchloremia (each 7%), hypophosphatemia (6%), decreased total protein (3%), hyperuricemia and hyperphosphatemia (each 2%), and hypernatremia and hypokalemia (each 1%).

Nervous system

Nervous system side effects have included neurotoxicity in cancer patients receiving intravenous phenylacetate, 250-300 mg/kg/day for 14 days, repeated at 4-week intervals. Manifestations were predominately somnolence, fatigue, and lightheadedness; with less frequent headache, dysgeusia, hypoacusis, disorientation, impaired memory, and exacerbation of a pre-existing neuropathy.

Psychiatric

Psychiatric side effects have included depression.

Renal

Renal side effects have included renal tubular acidosis.

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