Ornithine
US-FDASourced from openFDA
GET
/api/v1/drug/ornithineIndications
Sourced from openFDA- Aids in mobilization of fat deposits and cellulite.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Dosage & administration
Sourced from openFDADIRECTIONS: Adults: 2 to 3 sprays orally, three times daily. Children under twelve one half adult dosage. Do not take within 15 minutes of consuming food, beverage or brushing teeth. Consult a physician for use in children under 12 years of age.
Warnings & precautions
Sourced from openFDAProfessional Use Only If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away. If condition worsens, seek medical attention. KEEP OUT OF REACH OF CHILDREN Do not use if tamper evident seal is broken or missing. Store in a cool place after opening
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.
1 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.
- 1Vomiting1100%
Literature
Recent PubMed references pinned to Ornithine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- L-ornithine liposomal nanoparticles as a potent candidate for hepatic encephalopathy therapy via inhibiting Δ(1)-pyrroline-5-carboxylate dehydrogenase.Bioorganic chemistry · 2026 · Atta A, Mohamed TM, Salem MM, et al.PMID 42155203DOI 10.1016/j.bioorg.2026.110001
- Argininosuccinate synthase 1 (ASS1) orchestrates arginine metabolism and ornithine production to modulate CHIKV infection.Journal of virology · 2026 · Mishra N, Sravya M, Hanjankar S, et al.PMID 42037409DOI 10.1128/jvi.02098-24
- Analysis of catabolic products of L-arginine; L-ornithine and L-citrulline and the residual L-arginine using the HPLC and LC-MS.PloS one · 2026 · Prashath SPMID 42030331DOI 10.1371/journal.pone.0346976
- New insights for an old drug: difluoromethylornithine boosts the trypanocidal action of benznidazole on Trypanosoma cruzi in vitro and in vivo.Frontiers in cellular and infection microbiology · 2026 · Martínez SJ, Vanrell MC, Li X, et al.PMID 41982456DOI 10.3389/fcimb.2026.1794141
- Remote regulation of hepatic lipid secretion in the intestine by metabolic interaction of dietary arginine with ornithine.Scientific reports · 2026 · Nishi H, Nakanishi S, Xie L, et al.PMID 41957409DOI 10.1038/s41598-026-47841-8
- Transcriptomic comparison of Tylophora indica and Tylophora pauciflora leaves indicates major contribution of the ornithine pathway in tylophorine accumulation.Planta · 2026 · Pratibha, Yadav S, Mohapatra S, et al.PMID 41920371DOI 10.1007/s00425-026-04980-6
- Cl-amidine attenuates neutrophil extracellular trap-enclosed extracellular vesicle (NET-EV)-mediated thrombosis in diabetic mice.Thrombosis research · 2026 · Mohan AS, Radhakrishnan S, M G A, et al.PMID 41849925DOI 10.1016/j.thromres.2026.109658
- A novel GelMA-OrnMA electrically conductive bioink for developing engineered neural tissues.Biomaterials advances · 2026 · Sakr MA, Dixit K, Hyun K, et al.PMID 41795416DOI 10.1016/j.bioadv.2026.214787
Clinical trials
The 10 most recently updated of 124 ClinicalTrials.gov registrations naming Ornithine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Eflornithine (DFMO) for Ewing Sarcoma and OsteosarcomaRecruiting · Phase 2 · Interventional · 406 enrolled · Milton S. Hershey Medical CenterNCT07321912updated 2026-06-12
- Neuroblastoma Maintenance Therapy TrialActive not recruiting · Phase 2 · Interventional · 441 enrolled · Giselle ShollerNCT02679144updated 2026-06-12
- Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and SarcomasRecruiting · Phase 1 · Phase 2 · Interventional · 289 enrolled · Milton S. Hershey Medical CenterNCT06465199updated 2026-06-12
- Eflornithine (DFMO) and Etoposide for Relapsed/Refractory NeuroblastomaActive not recruiting · Phase 2 · Interventional · 131 enrolled · Giselle ShollerNCT04301843updated 2026-06-12
- Clinical Study of DTX301 AAV-Mediated Gene Transfer for Ornithine Transcarbamylase (OTC) DeficiencyActive not recruiting · Phase 3 · Interventional · 37 enrolled · Ultragenyx Pharmaceutical IncNCT05345171updated 2026-06-02
- Long Term Follow Up to Evaluate DTX301 in Adults With Late-Onset OTC DeficiencyActive not recruiting · Observational · 11 enrolled · Ultragenyx Pharmaceutical IncNCT03636438updated 2026-06-01
- An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard TherapyRecruiting · Phase 2 · Interventional · 40 enrolled · Fudan UniversityNCT07117630updated 2026-05-19
- DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or OsteosarcomaRecruiting · Phase 1 · Phase 2 · Interventional · 15 enrolled · Montefiore Medical CenterNCT06892678updated 2026-05-14
- Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid TumorsRecruiting · Phase 1 · Phase 2 · Interventional · 92 enrolled · Aminex Therapeutics, Inc.NCT07287917updated 2026-05-12
- DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed MedulloblastomaRecruiting · Phase 2 · Interventional · 118 enrolled · Giselle ShollerNCT04696029updated 2026-04-28
Frequently asked questions
- What is Ornithine used for?
- According to FDA labeling, Ornithine carries indications including: Aids in mobilization of fat deposits and cellulite.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
Note. Data for
ornithine 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.