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Sodium phenylbutyrate Side Effects

Brand Names: Buphenyl

Please note - some side effects for Sodium phenylbutyrate 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 Sodium phenylbutyrate - for the Consumer

Sodium Phenylbutyrate

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 Sodium Phenylbutyrate:

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 Sodium Phenylbutyrate:

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.

Sodium Phenylbutyrate 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 Sodium Phenylbutyrate 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 Sodium Phenylbutyrate 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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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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