Phenylalanine
US-FDASourced from openFDA
GET
/api/v1/drug/phenylalanineIndications
Sourced from openFDA- For the temporary relief of occasional headache, congestion, or lethargy due to sensitivity to phenolic compounds found in foods or other products.*ICD-10: R51.9
Dosage & administration
Sourced from openFDADIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.
Warnings & precautions
Sourced from openFDAIn case of overdose, get medical help or contact a poison control center right away. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.
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
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
799 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
- 1Nausea516.4%
- 2Parenteral Nutrition Associated Liver Disease506.3%
- 3Pyrexia445.5%
- 4Vomiting425.3%
- 5Death364.5%
- 6Chills354.4%
- 7Condition Aggravated334.1%
- 8Diarrhoea324.0%
- 9Dyspnoea303.8%
- 10No Adverse Event303.8%
- 11Fatigue283.5%
- 12Asthenia263.3%
- 13Palpitations232.9%
- 14Pruritus232.9%
- 15Chest Discomfort222.8%
Literature
Recent PubMed references pinned to Phenylalanine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Effect of subcutaneous foslevodopa/foscarbidopa therapy on non-motor symptoms in advanced PD patients.Journal of neurology · 2026 · Jander A, Bergner S, Schönwald B, et al.PMID 42260239DOI 10.1007/s00415-026-13890-2
- Pharmacokinetics and Tolerability of Entacapone, Levodopa, and Carbidopa Tablets in Healthy Chinese Subjects: A Randomized, Open-Label, Four-Period Crossover Study Under Fasting and Fed Conditions.Clinical pharmacology in drug development · 2026 · Wang J, Xu Y, Tao Y, et al.PMID 42212550DOI 10.1002/cpdd.70071
- Long-Term Surgical Outcomes and Influential Factors of Subthalamic Nucleus Deep Brain Stimulation for Dyskinesia in Parkinson's Disease: A 3-Year Longitudinal Cohort Study.Clinical interventions in aging · 2026 · Wang S, Xue T, Ma R, et al.PMID 42205153DOI 10.2147/CIA.S600031
- Investigating substrate specificity in arogenate versus prephenate dehydratases.BMC biology · 2026 · Clayton EJ, Smith-Uffen M, Tribble TW, et al.PMID 42204708DOI 10.1186/s12915-026-02586-8
- A deep learning-assisted turn-on fluorescent probe for L-BPA detection with mechanistic insight.Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy · 2026 · Qi Y, Wang L, Sun S, et al.PMID 42202743DOI 10.1016/j.saa.2026.128109
- [Chronic diarrhea in Parkinson's disease during Levodopa therapy].Praxis · 2026 · Macht A, Cathomas G, Bauer E, et al.PMID 42200385DOI 10.23785/PRAXIS.2026.05.006
- Interactions of the Tricyclic Antidepressant Drug Amitriptyline with L-DOPA in the Nucleus Accumbens, Prefrontal Cortex and Hippocampus of Unilaterally 6-OHDA-Lesioned Rats: Relevance to Depression in Parkinson's Disease.Biomolecules · 2026 · Kamińska K, Lenda T, Konieczny J, et al.PMID 42194091DOI 10.3390/biom16050743
- The effect of levodopa on the blood antioxidant system and metabolome in patients with Parkinson's disease.Biomeditsinskaia khimiia · 2026 · Abaimov DA, Fedorova TN, Shabalina AA, et al.PMID 42183764DOI 10.18097/PBMCR1642
Clinical trials
The 10 most recently updated of 1,111 ClinicalTrials.gov registrations naming Phenylalanine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Efficacy and Safety of the CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Adult Patients With Acute Myeloid Leukemia in First Complete RemissionNot yet recruiting · Interventional · 30 enrolled · Institute of Hematology & Blood Diseases Hospital, ChinaNCT07644481updated 2026-06-12
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk NeuroblastomaRecruiting · 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 MyelomaActive not recruiting · Phase 3 · Interventional · 306 enrolled · National Cancer Institute (NCI)NCT00602641updated 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 Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell TransplantationRecruiting · Phase 1 · Phase 2 · Interventional · 260 enrolled · National Cancer Institute (NCI)NCT05436418updated 2026-06-11
- Dopaminergic Dysfunction in Late-Life DepressionCompleted · Phase 2 · Interventional · 79 enrolled · Vanderbilt University Medical CenterNCT04469959updated 2026-06-11
- Haplo-Cord HSCT for AML/MDSRecruiting · Interventional · 82 enrolled · Fujian Medical University Union HospitalNCT07588360updated 2026-06-10
- A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor FluctuationsCompleted · Phase 3 · Interventional · 165 enrolled · Jiangsu HengRui Medicine Co., Ltd.NCT06596876updated 2026-06-08
- Intra-Arterial Chemotherapy for Newly Diagnosed, Residual, or Recurrent Atypical Choroid Plexus Papilloma and Choroid Plexus Carcinoma Prior to Second-Look SurgeryTerminated · Phase 1 · Interventional · 1 enrolled · Weill Medical College of Cornell UniversityNCT04994977updated 2026-06-08
- Busulfan & Melphalan Conditioning for Autologous Stem Cell Transplant (ASCT) and Lenalidomide MaintenanceCompleted · Phase 2 · Interventional · 78 enrolled · University Health Network, TorontoNCT01702831updated 2026-06-05
Frequently asked questions
- What is Phenylalanine used for?
- According to FDA labeling, Phenylalanine carries indications including: For the temporary relief of occasional headache, congestion, or lethargy due to sensitivity to phenolic compounds found in foods or other products.*. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What are the brand names for Phenylalanine?
- Phenylalanine 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.
Note. Data for
phenylalanine 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.