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Sodium Phenylbutyrate Side Effects

The most commonly reported side effects of sodium phenylbutyrate include death, diarrhoea, and product use complaint, based on 1,074 FDA adverse event reports from 2004 to 2025.

Sodium Phenylbutyrate side effects

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

1
Death19.8%213
2
Diarrhoea13.3%143
3
Product Use Complaint8.7%93
4
Nausea6.2%67
5
Vomiting5.6%60
6
Off Label Use5.3%57
7
Fatigue4.9%53
8
Hyperammonaemia4.7%51
9
Abdominal Discomfort4.7%51
10
Gastrointestinal Disorder4.2%45
11
Asthenia3.9%42
12
Dyspnoea3.7%40
13
Pneumonia3.6%39
14
Dizziness3.5%38
15
Decreased Appetite3.3%35

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

Report severity

62.7%Serious673 reports
26.5%Hospitalizations285 reports
27.1%Fatal291 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sodium Phenylbutyrate drug interactions

Other drugs that appear in adverse event reports alongside sodium phenylbutyrate. 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
Taurursodiol57.2%614
2
Edaravone10.6%114
3
Riluzole6.8%73
4
Glycerol-phenylbutyrate4.7%50
5
Carglumic-acid2.5%27
6
Bevacizumab1.2%13
7
Sodium-benzoate1.0%11
8
Erlotinib-hydrochloride1.0%11
9
Arginine-hydrochloride0.9%10
10
Tofersen0.7%8
11
Capecitabine0.7%7
12
Pazopanib-hydrochloride0.6%6
13
Lapatinib-ditosylate0.5%5
14
Everolimus0.5%5
15
Sodium-phenylacetate0.4%4

Taken alongside

1
Riluzole10.6%114
2
Edaravone9.1%98
3
Sodium-benzoate5.0%54
4
Arginine-hydrochloride4.7%50
5
Ergocalciferol4.4%47
6
Taurursodiol3.8%41
7
Levocarnitine3.0%32
8
Baclofen2.6%28
9
Acetaminophen2.5%27
10
Cyanocobalamin2.4%26
11
Ascorbic-acid2.2%24
12
Amlodipine2.2%24
13
Lisinopril2.1%23
14
Omeprazole2.1%23
15
Lactulose2.1%23

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 phenylbutyrate side effects

41.6% of sodium phenylbutyrate adverse event reports involve female patients and 45.3% involve male patients. The largest age group is adult at 45%. These figures reflect who reports side effects, not underlying risk.

Sex

Female41.6%
Male45.3%
Unknown13.0%

Age group

< 27.9%
2–117.9%
12–174.1%
18–6444.6%
65+35.4%

What is sodium phenylbutyrate used for

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

Amino Acid Metabolism DisorderAminoaciduriaAmmonia IncreasedAmyotrophic Lateral SclerosisArginase DeficiencyArgininosuccinate Lyase DeficiencyArgininosuccinate Synthetase DeficiencyAspartate-glutamate-transporter DeficiencyAcute Kidney InjuryAllan-herndon-dudley SyndromeAmmonia IncreasedAmyotrophic Lateral SclerosisAnuriaArginase DeficiencyArgininosuccinate Lyase Deficiency

Showing 15 of 58 indications

Sodium Phenylbutyrate brand names and reporting trend

Sodium Phenylbutyrate is sold under the brand name Relyvrio.

Brand names

Relyvrio172

Quarterly reports (20042025)

20052010201520202025

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

Taking sodium phenylbutyrate with another medication?

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