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Sodium Phenylacetate Side Effects

The most commonly reported side effects of sodium phenylacetate include hyperammonaemia, off label use, and death, based on 114 FDA adverse event reports from 2005 to 2025. 11.4% of reports found the drug to be ineffective.

Sodium Phenylacetate side effects

Percentages show how often each reaction appears relative to total reports for sodium phenylacetate.

1
Drug Ineffective11.4%13
2
Hyperammonaemia9.6%11
3
Off Label Use7.0%8
4
Death6.1%7
5
Ammonia Increased6.1%7
6
Ammonia Increased5.3%6
7
Brain Oedema5.3%6
8
Vomiting4.4%5
9
Hyperammonaemic Crisis4.4%5
10
Accidental Exposure To Product4.4%5
11
Drug Ineffective For Unapproved Indication4.4%5
12
Hyperammonaemia3.5%4
13
Hyperglycaemia3.5%4
14
Hyperammonaemic Encephalopathy3.5%4
15
Cardiac Arrest2.6%3

These are voluntary reports and do not establish that sodium phenylacetate caused these reactions.

Report severity

91.2%Serious104 reports
36.8%Hospitalizations42 reports
43.9%Fatal50 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sodium Phenylacetate drug interactions

Other drugs that appear in adverse event reports alongside sodium phenylacetate. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Sodium-benzoate62.3%71
2
Glycerol-phenylbutyrate14.9%17
3
Sodium-phenylbutyrate8.8%10
4
Lactulose8.8%10
5
Arginine-hydrochloride7.0%8
6
Levetiracetam7.0%8
7
Rifaximin7.0%8
8
Carglumic-acid4.4%5
9
Prednisone3.5%4
10
Mannitol2.6%3
11
Sodium-chloride2.6%3
12
Rifampin2.6%3
13
Heparin2.6%3
14
Oxaliplatin2.6%3
15
Gemcitabine2.6%3

Taken alongside

1
Sodium-benzoate36.0%41
2
Arginine-hydrochloride21.9%25
3
Epinephrine8.8%10
4
Dextrose7.9%9
5
Levetiracetam7.0%8
6
Lactulose7.0%8
7
Ferrous-sulfate6.1%7
8
Insulin5.3%6
9
Rifaximin5.3%6
10
Phenobarbital-sodium5.3%6
11
Heparin5.3%6
12
Carglumic-acid4.4%5
13
Atropine4.4%5
14
Glycerin4.4%5
15
Glucagon4.4%5

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports sodium phenylacetate side effects

42.1% of sodium phenylacetate adverse event reports involve female patients and 43.9% involve male patients. The largest age group is adult at 33%. These figures reflect who reports side effects, not underlying risk.

Sex

Female42.1%
Male43.9%
Unknown14.0%

Age group

< 234.9%
2–1119.3%
12–174.8%
18–6432.5%
65+8.4%

What is sodium phenylacetate used for

Conditions and purposes for which patients were taking sodium phenylacetate when the adverse event was reported.

Accidental Exposure To ProductAmmonia IncreasedArgininosuccinate Synthetase DeficiencyAmmonia IncreasedArgininosuccinate Synthetase DeficiencyCarbamoyl Phosphate Synthetase DeficiencyCervix DisorderComaCsf PressureHyperammonaemiaHyperammonaemic CrisisHyperglycaemiaHyperammonaemiaHyperammonaemic CrisisHyperammonaemic Encephalopathy

Showing 15 of 20 indications

Sodium Phenylacetate brand names and reporting trend

Sodium Phenylacetate is sold under the brand name Sodium Phenylacetate And Sodium Benzoate.

Brand names

Sodium Phenylacetate And Sodium Benzoate30

Quarterly reports (20052025)

20052025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking sodium phenylacetate with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.