Sodium Benzoate / Sodium Phenylacetate Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 25, 2024.

Applies to sodium benzoate / sodium phenylacetate: intravenous solution.

Other dosage forms:

• oral solution

Precautions

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine to make sure the medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause unwanted effects on the nervous system. Check with your doctor right away if you or your child have lightheadedness, muscle tingling or weakness, sleepiness or unusual drowsiness, or tiredness.

Check with your doctor right away if you or your child have more than one of the following symptoms while receiving this medicine: confusion; deep or fast breathing with dizziness; muscle tremors; nausea; numbness of the feet, hands, and around the mouth; rapid, deep breathing; restlessness; stomach cramps; or unusual tiredness or weakness.

Serious side effects

Along with its needed effects, sodium benzoate / sodium phenylacetate 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 or nurse immediately if any of the following side effects occur while taking sodium benzoate / sodium phenylacetate:

Other side effects

Some side effects of sodium benzoate / sodium phenylacetate 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 benzoate / sodium phenylacetate: intravenous solution.

General adverse events

The most frequently reported adverse reactions (incidence 6% or greater) are vomiting, hyperglycemia, hypokalemia, convulsions, and mental impairment.

Patients 30 days of age or younger had more blood and lymphatic system disorders and vascular disorders (specifically hypotension), while patients older than 30 days had more GI disorders (specifically nausea, vomiting, and diarrhea).^[Ref]

Nervous system

• Very common (10% or more): Nervous system disorders (22%)
• Common (1% to 10%): Convulsions, mental impairment, brain edema, coma
• Frequency not reported: Brain death, brain herniation, subdural hematoma, areflexia, ataxia, brain infarction, brain hemorrhage, cerebral atrophy, clonus, depressed level of consciousness, encephalopathy, nerve paralysis, increased intracranial pressure, tremor^[Ref]

Metabolic

• Very common (10% or more): Metabolism and nutrition disorders (21%)
• Common (1% to 10%): Hyperglycemia, hypokalemia, hyperammonemia, metabolic acidosis, hypocalcemia, acidosis
• Frequency not reported: Blood carbon dioxide changes, blood glucose changes, increased blood pH, partial pressure of carbon dioxide changes, alkalosis, dehydration, fluid overload/retention, hypoglycemia, hyperkalemia, hypernatremia, alkalosis, tetany^[Ref]

Respiratory

• Very common (10% or more): Respiratory, thoracic, and mediastinal disorders (15%)
• Common (1% to 10%): Respiratory distress
• Frequency not reported: Increased respiratory rate, acute respiratory distress syndrome, dyspnea, hypercapnia, hyperventilation, Kussmaul respiration, pneumonia aspiration, pneumothorax, pulmonary hemorrhage, pulmonary edema, respiratory acidosis, respiratory alkalosis, respiratory arrest/failure^[Ref]

Other

• Very common (10% or more): General disorders and administration-site conditions (14%), infections (12%), investigations (10%)
• Common (1% to 10%): Injury, poisoning, and procedural complications; pyrexia; injection-site reaction
• Frequency not reported: Asthenia, chest pain, multiorgan failure, edema, sepsis/septic shock, overdose^[Ref]

Gastrointestinal

• Very common (10% or more): GI disorders (13%)
• Common (1% to 10%): Vomiting, diarrhea, nausea
• Frequency not reported: Abdominal distension, GI hemorrhage^[Ref]

Hematologic

• Very common (10% or more): Blood and lymphatic system disorders (11%)
• Common (1% to 10%): Anemia, disseminated intravascular coagulation
• Frequency not reported: Coagulopathy, pancytopenia, thrombocytopenia^[Ref]

Cardiovascular

• Common (1% to 10%): Cardiac disorders, vascular disorders, hypotension
• Frequency not reported: Atrial rupture, bradycardia, cardiac or cardiopulmonary arrest/failure, cardiogenic shock, cardiomyopathy, pericardial effusion, decreased cardiac output, flushing, hemorrhage, hypertension, phlebothrombosis/thrombosis^[Ref]

Dermatologic

• Common (1% to 10%): Skin and subcutaneous tissue disorders
• Frequency not reported: Alopecia, blister, generalized pruritus, rash, urticaria^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection
• Frequency not reported: Anuria, urinary retention^[Ref]

Psychiatric

• Common (1% to 10%): Psychiatric disorders, agitation
• Frequency not reported: Acute psychosis, aggression, confusional state, hallucinations^[Ref]

Renal

• Common (1% to 10%): Renal and urinary disorders
• Frequency not reported: Renal failure^[Ref]

Hepatic

• Frequency not reported: Cholestasis, hepatic artery stenosis, hepatic failure, hepatotoxicity, jaundice^[Ref]

Ocular

• Frequency not reported: Blindness^[Ref]

Oncologic

• Frequency not reported: Acquired hemangioma^[Ref]

See also:

Further information

Sodium benzoate/sodium phenylacetate 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