Alanine

Mechanism-of-action class: Biological Macromolecular Activity.

• Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 7% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns.

• Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism (including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia), or hypersensitivity to one or more amino acids present in the solution.contraindicated

The total daily dose of the solution depends on the daily protein requirements and on the patient's metabolic and clinical response. Pediatric requirements for parenteral nutrition are constrained by the greater relative fluid requirements of the infant and greater caloric requirements per kilogram than in the adult. The recommended intravenous dose of Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is up to 2.5 g amino acid/kg/day for infants up to 10 kg. For infants and children larger than 10 kg, the total daily dose of amino acids should be up to 25 g amino acids/day for the first 10 kg of body weight plus 1 to 1.25 g amino acid for each kg of body weight over 10 kg. Initial amino acid dosage levels of 1 g/kg/day may be increased gradually in increments of 0.5 g/kg/day to approximate desired intake levels. Aminosyn-PF 7% should be diluted with dextrose prior to use. Nonprotein calories should constitute approximately 100 to 130 kcal/kg/day. Part of the nonprotein caloric requirement may be provided as lipid emulsion administered concurrently to provide up to 60% of daily calories at a dose not to exceed 4 g fat/kg/day. Fluid intake for the infant receiving central venous TPN should be approximately 125 mL/kg/day (range: 100 to 175 mL/kg/day), depending on the clinical condition of the patient. Premature infants with respiratory distress syndrome suspected of having a patent ductus arteriosus should be given fluids more cautiously.

Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. FREQUENT EVALUATION AND LABORATORY DETERMINATIONS ARE NECESSARY FOR PROPER MONITORING OF PARENTERAL NUTRITION. Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, hemogram, carbon dioxide content, serum osmolalities, blood cultures, and blood ammonia levels. Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake. Administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the solutions. Administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Hyperammonemia is of special significance in infants , as its occurrence in the syndrome caused by genetic metabolic defects is sometimes associated, although not necessarily in a causal relationship, with mental retardation. This reaction appears to be dose-related and is more likely to develop during prolonged therapy.

Local reactions consisting of erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids particularly if other substances, such as antibiotics, are also administered through the same site. In such cases the infusion site should be changed promptly to another vein. Use of large peripheral veins, inline filters, and slowing the rate of infusion may reduce the incidence of local venous irritation. Electrolyte additives should be spread throughout the day. Irritating additive medications may need to be injected at another venous site. Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Pregnancy Category C Animal reproduction studies have not been conducted with Aminosyn-PF 7%. It is also not known whether Aminosyn-PF 7% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminosyn-PF 7% should be given to a pregnant woman only if clearly needed.

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS .

• 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
• Sep 29, 1997NDANDA020734Baxter Hlthcare

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Aminosyn II 10% In Plastic Container, Injection, 0.1 (NDC 0990-7172-17)Active
  Sponsor: Otsuka ICU Medical LLC
  Updated Jun 4, 2026
• Aminosyn II 15% In Plastic Container, Injection, 0.15 (NDC 0990-7171-17)Active
  Sponsor: Otsuka ICU Medical LLC
  Updated Jun 4, 2026
• Aminosyn-PF 10%, Injection, 0.1 (NDC 0990-4179-05)Active
  Sponsor: Otsuka ICU Medical LLC · Reason: Shortage of an active ingredient
  Updated Jun 4, 2026
• Aminosyn-PF 7%, Injection, 0.07 (NDC 0990-4178-03)Active
  Sponsor: Otsuka ICU Medical LLC · Reason: Shortage of an active ingredient
  Updated Jun 4, 2026
• Clinisol 15% Sulfite Free In Plastic Container, Injection, 0.15 (NDC 0338-0502-03)Active
  Sponsor: Baxter Healthcare
  Updated Jun 2, 2026
• Clinisol 15% Sulfite Free In Plastic Container, Injection, 0.15 (NDC 0338-0502-06)Active
  Sponsor: Baxter Healthcare
  Updated Jun 2, 2026
• Plenamine, Injection, 0.15 (NDC 0264-4500-00)Active
  Sponsor: B. Braun Medical Inc.
  Updated Jun 2, 2026
• Plenamine, Injection, 0.15 (NDC 0264-4500-05)Active
  Sponsor: B. Braun Medical Inc.
  Updated Jun 2, 2026
• Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-03)Active
  Sponsor: Baxter Healthcare
  Updated Jun 2, 2026
• Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-04)Active
  Sponsor: Baxter Healthcare
  Updated Jun 2, 2026
• Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-06)Active
  Sponsor: Baxter Healthcare
  Updated Jun 2, 2026
• PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, Injection, 2.76 g/100 mL; 1.96 g/100 mL; 600 mg/100 mL; 1.02 g/100 mL; 2.06 g/100 mL; 1.18 g/100 mL; 1.08 g/100 mL; 1.08 g/100 mL; 1.35 g/100 mL; 760 mg/100 mL; 1 g/100 mL; 1.34 g/100 mL; 1.02 g/100 mL; 980 mg/100 mL; 320 mg/100 mL; 50 mg/100 mL; 1.44 g/100 mL (NDC 0338-0499-06)Active
  Sponsor: Baxter Healthcare
  Updated Jun 2, 2026
• Travasol, Injection, 2.07 g/100 mL; 1.15 g/100 mL; 1.03 g/100 mL; 480 mg/100 mL; 600 mg/100 mL; 730 mg/100 mL; 580 mg/100 mL; 400 mg/100 mL; 560 mg/100 mL; 680 mg/100 mL; 500 mg/100 mL; 420 mg/100 mL; 180 mg/100 mL; 40 mg/100 mL; 580 mg/100 mL (NDC 0338-0644-03)Active
  Sponsor: Baxter Healthcare · Reason: Shortage of an inactive ingredient component
  Updated Jun 2, 2026
• Travasol, Injection, 2.07 g/100 mL; 1.15 g/100 mL; 1.03 g/100 mL; 480 mg/100 mL; 600 mg/100 mL; 730 mg/100 mL; 580 mg/100 mL; 400 mg/100 mL; 560 mg/100 mL; 680 mg/100 mL; 500 mg/100 mL; 420 mg/100 mL; 180 mg/100 mL; 40 mg/100 mL; 580 mg/100 mL (NDC 0338-0644-04)Active
  Sponsor: Baxter Healthcare
  Updated Jun 2, 2026
• Travasol, Injection, 2.07 g/100 mL; 1.15 g/100 mL; 1.03 g/100 mL; 480 mg/100 mL; 600 mg/100 mL; 730 mg/100 mL; 580 mg/100 mL; 400 mg/100 mL; 560 mg/100 mL; 680 mg/100 mL; 500 mg/100 mL; 420 mg/100 mL; 180 mg/100 mL; 40 mg/100 mL; 580 mg/100 mL (NDC 0338-0644-06)Active
  Sponsor: Baxter Healthcare
  Updated Jun 2, 2026
• TrophAmine 10%, Injection, 0.1 (NDC 0264-1933-10)Active
  Sponsor: B. Braun Medical Inc.
  Updated Jun 2, 2026

1. 1Parenteral Nutrition Associated Liver Disease507.1%
2. 2Nausea446.2%
3. 3Pyrexia405.7%
4. 4Vomiting375.2%
5. 5Chills355.0%
6. 6Death355.0%
7. 7Dyspnoea304.2%
8. 8No Adverse Event304.2%
9. 9Diarrhoea263.7%
10. 10Asthenia243.4%
11. 11Palpitations233.3%
12. 12Pneumonia213.0%
13. 13Pruritus213.0%
14. 14Chest Discomfort202.8%
15. 15General Physical Health Deterioration182.5%

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

• Sustainable synchronized spectrofluorimetric determination of remdesivir and baricitinib: a first-derivative synchronous approach with multi-color and GLANCE assessment.
  Scientific reports · 2026 · El-Masry AA, El-Khouly OA, Elmansi H, et al.
  PMID 42243287DOI 10.1038/s41598-026-52054-0
• Dexpanthenol and parallel stress-response alterations in the subacute phase after experimental subarachnoid hemorrhage.
  Molecular biology reports · 2026 · Baydar AT, Canan M, Selcuk E, et al.
  PMID 42228189DOI 10.1007/s11033-026-11981-x
• Selected immunoendocrine and performance adaptations to upper-body plyometric training and β-alanine supplementation in male swimmers.
  Journal of the International Society of Sports Nutrition · 2026 · Gao H, Yu X, Guo Z, et al.
  PMID 42218755DOI 10.1080/15502783.2026.2679050
• Alanine Rewires the Communication Pathways Established During the Allosteric Activation of Liver Pyruvate Kinase by Fructose Bisphosphate.
  Journal of chemical information and modeling · 2026 · Kumutima J, Yao XQ, Hamelberg D, et al.
  PMID 42187048DOI 10.1021/acs.jcim.6c00643
• Bemnifosbuvir and remdesivir inhibit tick-borne encephalitis virus infection in complementary in vitro and ex vivo disease models.
  Antiviral research · 2026 · Leoni S, Schultz-Pernice I, Krátka Z, et al.
  PMID 42177917DOI 10.1016/j.antiviral.2026.106439
• Underlying substituted pyrazines formation in the glucose-alanine Maillard reaction: Carbon module labeling and carbonyl analysis strategy.
  Food research international (Ottawa, Ont.) · 2026 · Liu H, Zhao S, Li J, et al.
  PMID 42169359DOI 10.1016/j.foodres.2026.119409
• Remdesivir and Favipiravir as potential antivirals for poliovirus: In vitro efficacy and RNA-dependent RNA polymerase binding analysis.
  Virology · 2026 · Soheili P, Khodakhah F, Yousefi M, et al.
  PMID 42150251DOI 10.1016/j.virol.2026.110955
• Efficacy and safety of netarsudil compared with prostaglandin-based therapies: a Bayesian network meta-analysis.
  International ophthalmology · 2026 · Liu J, Zuo M, Liu X, et al.
  PMID 42133103DOI 10.1007/s10792-026-04100-z

The 10 most recently updated of 358 ClinicalTrials.gov registrations naming Alanine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Impact of Transferrin Saturation Guided Maintenance Treatment on Quality of Life in HFE Haemochromatosis
  Active not recruiting · Interventional · 239 enrolled · Rennes University Hospital
  NCT04779593updated 2026-06-12
• Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
  Recruiting · Phase 3 · Interventional · 478 enrolled · National Cancer Institute (NCI)
  NCT06172296updated 2026-06-12
• Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
  Active not recruiting · Phase 3 · Interventional · 306 enrolled · National Cancer Institute (NCI)
  NCT00602641updated 2026-06-11
• An Initial Investigation Into the Effects of β-Alanine on Performance and Physiological Responses During Simulated Wrestling Matches
  Active not recruiting · Interventional · 16 enrolled · China Medical University Hospital
  NCT07641907updated 2026-06-11
• MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
  Recruiting · Phase 2 · Interventional · 2,000 enrolled · National Cancer Institute (NCI)
  NCT05564390updated 2026-06-11
• The Application of Locoregional Therapy Combined With Systemic Therapy in the Perioperative Period of Huge Hepatocellular Carcinoma: A Retrospective Cohort Study
  Completed · Observational · 715 enrolled · Tongji Hospital
  NCT07639294updated 2026-06-10
• Hyperpolarized Carbon Metabolic Imaging in Multiple Sclerosis
  Recruiting · Phase 2 · Interventional · 40 enrolled · Ari Green
  NCT07510607updated 2026-06-08
• A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma
  Active not recruiting · Phase 1 · Interventional · 12 enrolled · University Health Network, Toronto
  NCT06377111updated 2026-06-08
• Remdesivir for the Treatment of Upper Respiratory Tract Infection Due to RSV in Immunocompromised Individuals
  Recruiting · Phase 2 · Interventional · 60 enrolled · Fred Hutchinson Cancer Center
  NCT06817889updated 2026-06-03
• Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
  Completed · Phase 2 · Interventional · 42 enrolled · National Cancer Institute (NCI)
  NCT03786783updated 2026-06-02

Frequently asked questions

How does Alanine work?

Mechanism-of-action class: Biological Macromolecular Activity.

What is Alanine used for?

According to FDA labeling, Alanine carries indications including: Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 7% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Alanine?

Alanine is classified as Amino Acid, Biological Macromolecular Activity, Metabolic Activity Alteration.

What are the brand names for Alanine?

Alanine 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 Alanine?

Alanine labeling lists contraindications including: Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism (including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia), or hypersensitivity to one or more amino acids present in the solution.. Always consult the full prescribing information and a clinician.