Serine
/api/v1/drug/serineIndications
Sourced from openFDA- 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.
Contraindications
Sourced from openFDA- 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
Dosage & administration
Sourced from openFDAThe 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.
Warnings & precautions
Sourced from openFDASafe, 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.
Adverse reactions
Sourced from openFDALocal 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.
Use in specific populations
Sourced from openFDAPregnancy 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.
Overdosage
Sourced from openFDAIn the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS .
Approval history
Sourced from openFDA- 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
FAERS reports
- 1Parenteral Nutrition Associated Liver Disease507.0%
- 2Nausea446.2%
- 3Pyrexia415.7%
- 4Vomiting375.2%
- 5Chills354.9%
- 6Death354.9%
- 7Dyspnoea304.2%
- 8No Adverse Event304.2%
- 9Diarrhoea263.6%
- 10Asthenia243.4%
- 11Palpitations233.2%
- 12Pneumonia212.9%
- 13Pruritus212.9%
- 14Chest Discomfort202.8%
- 15General Physical Health Deterioration182.5%
Literature
Recent PubMed references pinned to Serine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Uncoupling the TFIIH Core and Kinase Modules leads to misregulated RNA polymerase II CTD Serine 5 phosphorylation.eLife · 2026 · Giordano G, Buratowski R, Jeronimo C, et al.PMID 42258375DOI 10.7554/eLife.110091
- Mechanism-Based Polypharmacy as a Repurposing Strategy: The Case of D-Cycloserine and Lurasidone.Clinical and translational science · 2026 · Franzen AD, Svendsen JS, Kline CJ, et al.PMID 42251640DOI 10.1111/cts.70624
- Steric Induced Inhibition of Serine β -Lactamase Catalyzed Hydrolysis.Chemphyschem : a European journal of chemical physics and physical chemistry · 2026 · Thakkur V, Das CK, Verma S, et al.PMID 42174373DOI 10.1002/cphc.70414
- Disrupting the mtr-operon in Methanosarcina acetivorans enables methyl-reducing methanogenesis with hydrogen and serine as the alternative electron donors.FEMS microbiology letters · 2026 · Bao J, Somvanshi T, Tian Y, et al.PMID 42172100DOI 10.1093/femsle/fnag061
- Enhanced Renal Accumulation of Polyserine Synthesized from Unprotected Serine N-Carboxyanhydride.Biomacromolecules · 2026 · Zhao J, Li P, Li N, et al.PMID 42167884DOI 10.1021/acs.biomac.6c00223
- A novel sequential ketamine and D-cycloserine/lurasidone therapy for bipolar depression with acute suicidal ideation.Expert opinion on investigational drugs · 2026 · Takahashi M, Shelton RCPMID 42166622DOI 10.1080/13543784.2026.2674645
- Rescue of astrocytic ASCT1 expression and d-serine uptake attenuates remifentanil-induced hyperalgesia.Biochemical and biophysical research communications · 2026 · Chen C, Shi Y, Wan Y, et al.PMID 42161059DOI 10.1016/j.bbrc.2026.153944
- A novel mechanism of exercise-induced cognitive protection in ageing: D-amino acid oxidase /D-serine-dependent modulation of NMDAR signalling.Ageing research reviews · 2026 · Tong X, Yang Y, Liu Z, et al.PMID 42142595DOI 10.1016/j.arr.2026.103179
Clinical trials
The 10 most recently updated of 814 ClinicalTrials.gov registrations naming Serine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Investigation of Medical Management to Prevent Episodes of Diverticulitis TrialCompleted · Interventional · 71 enrolled · University of WashingtonNCT05681559updated 2026-06-12
- Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural EffusionRecruiting · Early phase 1 · Interventional · 30 enrolled · M.D. Anderson Cancer CenterNCT06184321updated 2026-06-12
- Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated CoagulationNot yet recruiting · Phase 4 · Interventional · 40 enrolled · NYU Langone HealthNCT07644923updated 2026-06-12
- CleaRRAflow: Isotonic Solution vs. TPA for IVH ClearanceNot yet recruiting · Phase 4 · Interventional · 80 enrolled · David DornbosNCT07643493updated 2026-06-11
- Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery OcclusionRecruiting · Phase 3 · Interventional · 338 enrolled · The First Affiliated Hospital of University of Science and Technology of ChinaNCT05827042updated 2026-06-09
- A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen WellRecruiting · Phase 3 · Interventional · 1,325 enrolled · Boehringer IngelheimNCT07361302updated 2026-06-09
- Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC FusionsRecruiting · Phase 1 · Phase 2 · Interventional · 336 enrolled · IDEAYA BiosciencesNCT03947385updated 2026-06-08
- A Pilot Trial of One-Day Accelerated TMS and D-cycloserine in Suicidal Patients With Borderline Personality DisorderRecruiting · Phase 1 · Phase 2 · Interventional · 20 enrolled · Mclean HospitalNCT07460947updated 2026-06-04
- Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid CancerActive not recruiting · Phase 3 · Interventional · 153 enrolled · Novartis PharmaceuticalsNCT04940052updated 2026-06-04
- D-SPARK: A Clinical Trial of D-Serine for Modifying Parkinson's Disease ProgressionRecruiting · Phase 2 · Interventional · 100 enrolled · Haukeland University HospitalNCT07312110updated 2026-06-04
Frequently asked questions
- What is Serine used for?
- According to FDA labeling, Serine 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 are the brand names for Serine?
- Serine 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 Serine?
- Serine 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.
serine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.