Arginine

Mechanism-of-action class: Biological Macromolecular Activity.

• R-Gene ® 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness. It can be used as a diagnostic aid in such conditions as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism and problems of growth and stature.

• The administration of R-Gene ® 10 is contraindicated in persons having known hypersensitivity to any ingredient in this product.contraindicated

Adult Dosage The recommended adult dose is 30 g arginine hydrochloride (300 mL of R-Gene ® 10) administered by intravenous infusion over 30 minutes. The total dose should not exceed 30 g arginine hydrochloride. See Directions for Use for preparation instructions. Pediatric Dosage The recommended pediatric dose is 0.5 g/kg arginine hydrochloride (5 mL/kg of R-Gene ® 10) administered by intravenous infusion over 30 minutes. The total dose should not exceed 30 g arginine hydrochloride. • For patients weighing 59 kg or less , withdraw a weight based dose from a sealed R-Gene ® 10 bottle and place in a separate container for intravenous infusion to avoid the inadvertent delivery and administration of the total volume from the commercially available container. See Directions for Use for preparation instructions. • For patients weighing 60 kg or more , the recommended dose is 30 g arginine hydrochloride (300 mL of R-Gene ® 10). See Directions for Use for preparation instructions Test Procedure The intravenous infusion of R-Gene ® 10 is a part of the test for measurement of pituitary reserve of human growth hormone and, for successful administration of the test, clinical conditions and procedures should be as follows: 1. The test should be scheduled in the morning following a normal night's sleep, and an overnight fast should continue through the test period. 2. Patients must be placed at bed rest for at least 30 minutes before the infusion begins. Care should be taken to minimize apprehension and distress. This is particularly important in children. 3.

There have been reports of overdosage of R-Gene ® 10 in pediatric patients leading to death. EXTREME CAUTION MUST BE EXERCISED WHEN INFUSING R-GENE ® 10 INTO PEDIATRIC PATIENTS. OVERDOSAGE OF R-GENE ® 10 IN PEDIATRIC PATIENTS CAN RESULT IN HYPERCHLOREMIC METABOLIC ACIDOSIS, CEREBRAL EDEMA, OR POSSIBLY DEATH. Hypersensitivity reactions, including anaphylaxis have been reported. Appropriate medical support should be available during R-Gene ® 10 administration. If anaphylaxis or other serious hypersensitivity reaction occurs, R-Gene ® 10 should be discontinued and appropriate medical treatment initiated. R-Gene ® 10 should always be administered by intravenous infusion because of its hypertonicity. R-Gene ® 10 is a diagnostic aid and is not intended for therapeutic use.

Adverse reactions associated with 1670 infusions in premarketing studies were as follows: Non-specific side effects consisting of nausea, vomiting, headache, flushing, numbness and local venous irritation were reported in approximately 3% of the patients. One patient had an allergic reaction which was manifested as a confluent macular rash with reddening and swelling of the hands and face. The rash subsided rapidly after the infusion was terminated and 50 mg of diphenhydramine were administered. One patient had an apparent decrease in platelet count from 150,000 to 60,000. One patient with a history of acrocyanosis had an exacerbation of this condition following infusion of R-Gene ® 10. Post Marketing Experience: The following adverse events have been reported during post-marketing use: extravasation leading to burn-like reaction and/or skin necrosis requiring surgical intervention, hypersensitivity reactions including anaphylaxis, and hematuria that in some cases occurred 1–2 days after an R-Gene ® 10 administration. Because these adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Pregnancy Reproduction studies have been performed in rabbits and mice at doses 12 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to R-Gene ® 10 (10% Arginine Hydrochloride Injection, USP). There have been no adequate or well controlled studies for the use of R-Gene ® 10 in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should not be used during pregnancy.

An overdosage may cause a transient metabolic acidosis with hyperventilation, which could lead to death (see " WARNINGS "). In most cases the acidosis will self-compensate and the base deficit will return to normal following completion of the infusion. If the condition persists, the deficit should be determined and corrected by a calculated dose of an alkalizing agent.

• Feb 28, 1973NDANDA016931Pharmacia And Upjohn
• Jul 20, 1984NDANDA019018B Braun
• Aug 23, 1984NDANDA018931Baxter Hlthcare
• Sep 6, 1985NDANDA019398Otsuka Icu Medcl
• Oct 17, 1986NDANDA019492Otsuka Icu Medcl
• Dec 19, 1991NDANDA020041Otsuka Icu Medcl
• Dec 19, 1991NDANDA020015Otsuka Icu Medcl
• Mar 26, 1997NDANDA020678Baxter Hlthcare

1. 1Nausea955.7%
2. 2Diarrhoea845.0%
3. 3Fatigue835.0%
4. 4Vomiting764.5%
5. 5Dyspnoea623.7%
6. 6Pain603.6%
7. 7Headache593.5%
8. 8Pyrexia583.5%
9. 9Asthenia553.3%
10. 10Pruritus543.2%
11. 11Dizziness533.2%
12. 12Death523.1%
13. 13Drug Ineffective503.0%
14. 14Parenteral Nutrition Associated Liver Disease503.0%
15. 15Chills452.7%

Recent PubMed references pinned to Arginine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Polyproline Modulates Membrane Translocation of Arginine-Rich Cell-Penetrating Peptides: Insights from Molecular Dynamics Simulations.
  The Journal of membrane biology · 2026 · Choe S, Mariam A, Ejaz M, et al.
  PMID 42250151DOI 10.1007/s00232-026-00381-8
• In vitro assessment of experimental bioactive tooth gel formulas containing L-arginine, ginger and eggshell for remineralization and anti-bacterial effect.
  Scientific reports · 2026 · Saleh RS, El-Hashemy HA, Elgamily HM, et al.
  PMID 42243363DOI 10.1038/s41598-026-54994-z
• Association Between L-Arginine Levels and Microalbuminuria in Sickle Cell Disease: A Cross-Sectional Study in a Tertiary Hospital in Northwest Nigeria.
  Nigerian journal of clinical practice · 2026 · Gwarzo DH, Kuliya-Gwarzo A, Yusuf AA, et al.
  PMID 42241207DOI 10.4103/njcp.njcp_853_25
• Self-activation by a C-terminal domain arginine finger regulates GTP hydrolysis in bacterial zinc metallochaperones.
  Proceedings of the National Academy of Sciences of the United States of America · 2026 · Rocchio JS, Osterberg MK, McRae EM, et al.
  PMID 42228530DOI 10.1073/pnas.2608072123
• Arginine methylation of human DNA topoisomerase I by PRMT5 facilitates DNA relaxation.
  Nucleic acids research · 2026 · Basu S, Bhattacharyya A, Khan MA, et al.
  PMID 42216760DOI 10.1093/nar/gkag503
• Arginine Promotes Antler Reserve Mesenchymal Cell Proliferation and Chondrogenesis via Altered Wnt/β-catenin and mTOR Signaling.
  Frontiers in bioscience (Landmark edition) · 2026 · Deng R, Zhang Y, Liu H, et al.
  PMID 42216523DOI 10.31083/FBL50041
• Mechanistic insights into pulsed electric field-induced oxidative degradation of arginine and glutamic acid: Combined experimental characterization and DFT computation.
  Food research international (Ottawa, Ont.) · 2026 · Hu X, Jiang Q, Tu Z, et al.
  PMID 42215105DOI 10.1016/j.foodres.2026.119437
• Targeting Arginine Metabolism to Reverse Immune Paralysis in Cancer.
  Anticancer research · 2026 · Borsatti GE, Cutruzzolà F, Spizzichino S, et al.
  PMID 42203313DOI 10.21873/anticanres.18174

The 10 most recently updated of 765 ClinicalTrials.gov registrations naming Arginine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• 177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 18 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  NCT06991738updated 2026-06-12
• Vasopressin and Epinephrine Versus Epinephrine Alone in Cardiac Arrest
  Completed · Phase 4 · Interventional · 2,416 enrolled · Hospices Civils de Lyon
  NCT00127907updated 2026-06-11
• Study to Assess the Efficacy, Safety, and Tolerability of NOC-110 in Adults With Refractory or Unexplained Chronic Cough
  Active not recruiting · Phase 2 · Interventional · 455 enrolled · Nocion Therapeutics
  NCT06504446updated 2026-06-11
• NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
  Active not recruiting · Phase 1 · Interventional · 31 enrolled · Novartis Pharmaceuticals
  NCT06379217updated 2026-06-10
• A Study to Evaluate the Mass Balance, Metabolism, Elimination, and Drug Levels of [14C]-BMS-986504 (MRTX1719) in Participants With Advanced Solid Tumors With Homozygous Methylthioadenosine Phosphorylase Deletion
  Recruiting · Phase 1 · Interventional · 8 enrolled · Bristol-Myers Squibb
  NCT06672523updated 2026-06-08
• Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)
  Recruiting · Phase 1 · Phase 2 · Interventional · 30 enrolled · M.D. Anderson Cancer Center
  NCT06085729updated 2026-06-08
• A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
  Recruiting · Phase 1 · Interventional · 260 enrolled · IDEAYA Biosciences
  NCT07277413updated 2026-06-08
• A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
  Recruiting · Phase 2 · Interventional · 520 enrolled · Janssen Research & Development, LLC
  NCT05498428updated 2026-06-05
• Inhibition of HBV Replication and Biological Reversal of Cirrhosis (F3-F4) and HCC by Flavonoids
  Completed · Phase 4 · Interventional · 134 enrolled · Trieu, Nguyen Thi, M.D.
  NCT07084948updated 2026-06-05
• Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)
  Recruiting · Phase 2 · Interventional · 36 enrolled · The Methodist Hospital Research Institute
  NCT05660083updated 2026-06-04

Frequently asked questions

How does Arginine work?

Mechanism-of-action class: Biological Macromolecular Activity.

What is Arginine used for?

According to FDA labeling, Arginine carries indications including: R-Gene ® 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness. It can be used as a diagnostic aid in such conditions as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism and problems of growth and stature.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Arginine?

Arginine is classified as Biological Macromolecular Activity, Metabolic Activity Alteration.

What are the brand names for Arginine?

Arginine is marketed under brand names including Aminosyn 10%, Sulfite-Free, Aminosyn 3.5 % M, Sulfite Free, Aminosyn 8.5 % with Electrolytes, Sulfite-Free, Aminosyn 8.5%, Sulfite-Free, Aminosyn II 10 %, Aminosyn II 15%, Aminosyn II 8.5 % with Electrolytes, Sulfite-Free, Aminosyn II 8.5 %, Sulfite-Free.

What are the contraindications for Arginine?

Arginine labeling lists contraindications including: The administration of R-Gene ® 10 is contraindicated in persons having known hypersensitivity to any ingredient in this product.. Always consult the full prescribing information and a clinician.