Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.



August 28, 2018

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Common name(s) Preparation(s)
  • (S)-2-Amino-5-[(aminoiminomethyl) amino] pentanoic acid
  • L-Arginine


  • DL-Arginine
  • L-Arginine
  • L-Arginine alpha-ketoglutarate
  • L-Arginine ketoisocaproic acid
  • L-Arginine monohydrochloride


References: Proper names: NIH 2018, O'Neil et al. 2018; Common name: NIH 2018, O'Neil et al. 2018; Source materials: NIH 2018, BP 2009, USP 32 2009, Ph. Eur. 2007.

Route of Administration


Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)



Adults 18 years and older


Improvement in exercise capacity in individuals with stable CVD

6 - 21 grams of L-Arginine, per day; Not to exceed 8 grams per single dose (Doutreleau et al. 2010; Shao and Hathcock 2008; Doutreleau et al. 2006; Evans et al. 2004: Lim et al. 2004; Palloshi et al. 2004; Bode-Bogër et al. 2003; Bednarz et al. 2000; Hambrecht et al. 2000; Lerman et al. 1998; Adams et al. 1997; Ceremuzynski et al. 1997; Clarkson et al. 1996; Rector et al. 1996).

Protein synthesis

0.21 - 21 grams of L-Arginine, per day; Not to exceed 8 grams per single dose (Shao and Hathcock 2008; IOM 2005; Evans et al. 2004; Bode-Bogër et al. 2003; Sydow et al. 2002).

Direction(s) for use

No statement required.

Duration(s) of Use

Products providing more than 0.42 and up to 9 g of L-Arginine, per day

Consult a health care practitioner/health care provider/health care professional/doctor/ physician for use beyond 6 weeks if you suffer from a cardiovascular disease (Shao and Hathcock 2008; Sydow et al. 2002; Hambrecht et al. 2000; Clarkson et al.1996; Rector et al. 1996).

Products providing more than 9 g and up to 14 g of L-Arginine, per day

Products providing more than 14 g of L-Arginine, per day

Risk Information

Caution(s) and warning(s)

All products

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.

Products providing more than 0.42 g of L-Arginine, per day


Products providing more than 0.42 g of L-Arginine, per day

Do not use this product if you have had a heart attack/myocardial infarction (Schulman et al. 2006).

Known adverse reaction(s)

Products providing more than 0.42 g of L-Arginine, per day

Some people may experience gastrointestinal discomfort (such as diarrhea) (Grimble 2007; Evans et al. 2004; IOM 2005; Clarkson et al. 1996).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.


References Cited

Adams MR, McCredie R, Jessup W, Robinson J, Sullivan D, Celermajer DS. 1997. Oral L-arginine improves endothelium-dependent dilatation and reduces monocyte adhesion to the endothelial cells in young men with coronary artery disease. Atherosclerosis 129(2):261-269.

Adams MR, Forsyth CJ, Jessup W, Robinson J, Celermajer DS. 1995. Oral L-arginine inhibits platelet aggregation but does not enhance endothelium-dependent dilation in healthy young men. Journal of the American College of Cardiology 26(4):1054-1061.

Alexander JW, Metze TJ, McIntosh MJ, Goodman HR, First MR, Munda R, Cardi MA, Austin JN, Goel S, Safdar S, Greenberg N, Chen X, Woodle ES. 2005. The influence of immunomodulatory diets on transplant success and complications. Transplantation 79:460-465. 

Bednarz B, Wolk R, Chamiec T, Herbaczynska-Cedro K, Winek D, Ceremuzynski L. 2000. Effects of oral L-arginine supplementation on exercise-induced QT dispersion and exercise tolerance in stable angina pectoris. International Journal of Cardiology 75(2-3):205-210.

Bode-Böger SM, Muke J, Surdacki A, Brobant G, Böger RH, Frölich J. 2003. Oral L-arginine improves endothelial function in healthy individuals older than 70 years. Vascular Medicine 8(2):77-81.

BP 2009: British Pharmacopoeia Commission. 2008. British Pharmacopoeia 2009, Volume II. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).

Ceremuzynski L, Chamiec T, Herbaczynska-Cedro K. 1997. Effect of supplemental oral L-arginine on exercise capacity in patients with stable angina pectoris. The American Journal of Cardiology 80(3):331-333.

Clarkson P, Adams MR, Powe AJ, Donald AE, McCredie R, Robinson J, McCarthy SN, Keech A, Celermajer DS, Deanfield JE. 1996. Oral L-arginine endothelium-dependent dilation in hypercholesterolemic young adults. Journal of Clinical Investigation 97(8):1989-1994.

De Nicola L, Bellizzi V, Minutolo R, Andreucci M, Capuano A, Garibotto G, Corso G, Andreucci VE, Cianciaruso B. 1999. Randomized, double-blind, placebo-controlled study of arginine supplementation in chronic renal failure. Kidney International 56:674-684.

Doutreleau S, Rouyer O, Di Marco P, Lonsdorfer E, Richard R, Piquard F, Geny B. 2010. L-Arginine supplementation improves exercise capacity after a heart transplant. American Journal of Clinical Nutrition. Doi: 10.3945/ajcn.2009.27881.

Doutreleau S, Mettauer B, Piquard F, Rouyer O, Schaefer A, Lonsdorfer J., Beny B. 2006. Chronic L-Arginine Supplementation Enhances Endurance Exercise Tolerance in Heart Failure Patients. International Journal of Sports Medicine 27(7):567-572.

Evans WR, Fernstrom JD, Thompson J, Morris SM Jr, Kuller LH. 2004. Biochemical responses of healthy subjects during dietary supplementation with L-arginine. Journal of Nutritional Biochemistry 15(9):534-539.

Grimble GK. 2007. Adverse gastrointestinal effects of arginine and related amino acids. The Journal of Nutrition 137(6 Suppl 2):1693S-1701S.

Groff J, Gropper S. 2000. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA): Wadsworth/Thomson Learning. 

Hambrecht R, Hilbrich L, Erbs S, Gielen S, Fiehn E, Schoene N, Schuler. 2000. Correction of endothelial dysfunction in chronic heart failure: additional effects of exercise training and oral L-arginine supplementation. Journal of the American College of Cardiology 35(3):706-713.

Huynh NT, Tayek JA. 2002. Oral arginine reduces systemic blood pressure in type 2 diabetes: Its potential role in nitric oxide generation. American College of Nutrition 21(5):422-427.

IOM 2006: Otten JJ, Pitzi Hellwig J, Meyers LD, editors. 2006. Institute of Medicine Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press.

IOM 2005: Institute of Medicine. Panel on Dietary Reference Intakes for Electrolytes and Water, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. 2005. Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Washington (DC): National Academies Press.

Lekakis JP, Papathanassiou S, Papaioannou TG, Papamichael CM, Zakopoulos N, Kotsis V, Dagre AG, Stamatelopoulos K, Protogerou A, Stamatelopoulos SF. 2002. Oral L-arginine improves endothelial dysfunction in patients with essential hypertension. International Journal of Cardiology 86(2-3):317-323.

Lerman A, Burnett JC, Higano ST, McKinley LJ, Holmes Jr DR. 1998. Long-term L-arginine supplementation improves small-vessel coronary endothelial function in humans. Circulation 97(21):2123-2128.

Lim SD, Mooradian SJ, Goldberg CS, Gomez C, Crowley DC, Rocchini AP, Charpie JR. 2004. Effect of oral L-arginine on oxidant stress, endothelial dysfunction, and systemic arterial pressure in young cardiac transplant recipients. The American Journal of Cardiology 94(6):828-831.

Nagaya N, Uematsu M, Oya H, Sato N, Sakamaki F, Kyotani S, Ueno K, Nakanishi N, Yamagishi M, Miyatake K. 2001. Short-term oral administration of L-arginine improves hemodynamics and exercise capacity in patients with precapillary pulmonary hypertension. American Journal of Respiratory and Critical Care Medicine 163(4):887-891.

NIH 2018: National Institutes of Health. ChemIDplus advanced. Bethesda (MD): Specialized Information Services, National Library of Medicine, National Institutes of Health, US Department of Health & Human Services. [Accessed 2018 June 15]. Available from:Next link will take you to another Web site  http://chem.sis.nlm.nih.gov/chemidplus

O'Neil MJ, Heckelman PE, Koch CB, Roman KJ, editors. 2018. The Merck Index: An

Encyclopedia of Chemicals, Drugs, and Biologicals [online]. Whitehouse Station (NJ): Merck & Co., Inc. Electronic version [Accessed 2018 June 15]. Available from:Next link will take you to another Web site  https://www.medicinescomplete.com/#/

Palloshi A, Fragasso G, Piatti P, Monti LD, Setola E, Valsecchi G, Galluccio E, Chierchia SL, Morgonato A. 2004. Effect of oral L-arginine on blood pressure and symptoms and endothelial function in patients with systemic hypertension, positive exercise tests, and normal coronary arteries. The American Journal of Cardiology 93(7):933-935.

Parker JO, Parker JD, Caldwell RW, Farrell B, Kaesemeyer WH. 2002. The effect of supplemental L-arginine on tolerance development during continuous transdermal nitroglycerin therapy. Journal of the American College of Cardiology 39(7):1199-1203.

Ph. Eur. 2007: European Pharmacopoeia Commission. 2007. European Pharmacopoeia, 6th edition, Volume 1. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).

Rector TS, Bank AJ, Mullen KA, Tschumperlin LK, Sih R, Pillai K, Kubo SH. 1996. Randomized, double-blind, placebo-controlled study of supplemental oral –arginine in patients with heart failure. Circulation 93(12):2135-2141.

Schulman SP, Becker LC, Kass DA, Champion HC, Terrin ML, Forman S, Ernst KV, Kelemen MD, Townsend SN, Capriotti A, Hare JM, Gerstenblith G. 2006. L-Arginine therapy in acute myocardial infarction: the vascular interaction with age in myocardial infarction (VINTAGE MI) randomised clinical trial. Journal of American Medical Association 295(1):58-64.

Shao A, Hathcock JN. 2008. Risk assessment for the amino acids taurine, L-glutamine and Larginine. Regulatory Toxicology and Pharmacology 50:376-399.

Shils ME, Olson JA, Shike M, Ross AC, editors. Modern Nutrition in Health and Disease, 10th edition. Philadelphia (PA): Lippincott Williams and Wilkins; 2006.

Siani A, Pagano E, Iacone R, Iacoviello L, Scopacasa F, Strazzullo P. 2000. Blood pressure and metabolic changes during dietary L-arginine supplementation in humans. American Journal of Hypertension 13(5):547-551.

Sydow K, Schwedhelm E, Arakawa N, Bode-Böger SM, Tsikas D, Hornig B, Frölich, Böger RH. ADMA and oxidative stress are responsible for endothelial dysfunction in hyperhomocyst(e)inemia: effects of L-arginine and B vitamins. Cardiovascular Research 57(1):244-252.

Tangphao O, Chalon S, Moreno HJr, Hoffman BB, Blaschke TF. Pharmacokinetics of L-arginine during chronic administration to patients with hypercholesterolaemia. Clinical Science 96:199-207.

USP 32 2009: United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.

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References Reviewed

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