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Arginine Side Effects

The most commonly reported side effects of arginine include fatigue, off label use, and headache, based on 1,122 FDA adverse event reports from 2004 to 2025. 6.8% of reports found the drug to be ineffective.

Arginine side effects

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

1
Fatigue7.0%78
2
Drug Ineffective6.8%76
3
Off Label Use6.6%74
4
Headache4.8%54
5
Vomiting4.6%52
6
Haematuria4.5%51
7
Diarrhoea4.4%49
8
Dizziness4.1%46
9
Nausea3.9%44
10
Hypotension3.7%42
11
Asthenia3.4%38
12
Hyperammonaemia2.9%33
13
Arthralgia2.9%32
14
Pain2.8%31
15
Pyrexia2.7%30

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

Report severity

71.6%Serious803 reports
34.1%Hospitalizations383 reports
8.1%Fatal91 reports

Seriousness is determined by the reporter, not by OpenClaim.

Arginine drug interactions

Other drugs that appear in adverse event reports alongside arginine. 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
Glycerol-phenylbutyrate12.7%142
2
Clonidine5.2%58
3
Sodium-oxybate4.3%48
4
Sodium-phenylbutyrate4.2%47
5
Levetiracetam3.1%35
6
Prednisone2.4%27
7
Sodium-benzoate2.0%23
8
Somatropin2.0%22
9
Lenalidomide2.0%22
10
Carglumic-acid1.9%21
11
Sildenafil-citrate1.7%19
12
Relugolix1.5%17
13
Metformin1.4%16
14
Methotrexate1.4%16
15
Clobazam1.3%15

Taken alongside

1
Ergocalciferol20.6%231
2
Ascorbic-acid14.2%159
3
Aspirin13.3%149
4
Acetaminophen11.5%129
5
Fish9.5%107
6
Levothyroxine-sodium8.9%100
7
Calcium8.5%95
8
Cyanocobalamin8.3%93
9
Furosemide8.2%92
10
Magnesium-acetate-tetrahydrate7.9%89
11
Omeprazole7.8%87
12
Atorvastatin-calcium7.1%80
13
Amlodipine6.4%72
14
Folic-acid6.1%69
15
Levocarnitine5.9%66

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 arginine side effects

36.5% of arginine adverse event reports involve female patients and 52.8% involve male patients. The largest age group is adult at 44%. These figures reflect who reports side effects, not underlying risk.

Sex

Female36.5%
Male52.8%
Unknown10.7%

Age group

< 28.9%
2–1113.9%
12–175.8%
18–6443.9%
65+27.5%

What is arginine used for

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

Alanine Aminotransferase IncreasedAmino Acid Metabolism DisorderAmmonia IncreasedAndrogen DeficiencyAndrogenetic AlopeciaAngina PectorisAngiopathyArgininosuccinate Lyase DeficiencyArgininosuccinate Synthetase DeficiencyArrhythmiaAstheniaAbdominal PainAcid Base BalanceAmino Acid Level IncreasedAmmonia Increased

Showing 15 of 139 indications

Arginine brand names and reporting trend

Arginine is sold under the brand name R-gene 10.

Brand names

R-gene 101,146

Quarterly reports (20042025)

20052010201520202025

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

Taking arginine with another medication?

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