Choline
/api/v1/drug/cholineMechanism of action
Sourced from openFDAMechanism-of-action class: Biological Macromolecular Activity.
Indications
Sourced from openFDA- Uses temporarily relieves minor aches and pains due to: ○ headache ○ minor arthritis pain ○ muscle aches ○ menstrual cramps ○ backache temporarily reduces feverICD-10: R50.9, R51.9
Dosage & administration
Sourced from openFDADirections do not take more than directed. adults and children 12 years of age and over: take 30mL every 6 hours, while symptoms persist do not take exceed 4 doses in any 24 hours unless directed by a doctor children under 12 years of age: ask a doctor use enclosed dose cup
Warnings & precautions
Sourced from openFDAReye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Salicylates (NSAIDs) may cause a severe allergic reaction which may include: hives skin reddening rash facial swelling shock asthma (wheezing) Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/ fever reducer. Ask a doctor before use if stomach bleeding warning applies to you you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have a history of stomach problems such as heartburn, upset stomach, stomach pain, or ulcers you have asthma Ask a doctor or pharmacist before use if under a doctor's care for any serious condition taking a prescription drug for diabetes, gout, or arthritis.
Approval history
Sourced from openFDA- Sep 12, 2012NDANDA203155Mcprf
- Mar 26, 2025NDANDA216665Soleno Therap
FAERS reports
- 1Oedema Peripheral6620%
- 2Oedema4614%
- 3Peripheral Swelling4413%
- 4Blood Glucose Increased3912%
- 5Fluid Retention3711%
- 6Weight Increased3611%
- 7Drug Ineffective226.7%
- 8Dyspnoea206.1%
- 9Hyperglycaemia206.1%
- 10Hair Growth Abnormal175.2%
- 11Abnormal Behaviour164.9%
- 12Hypertrichosis154.6%
- 13Hyperphagia144.3%
- 14Pulmonary Oedema144.3%
- 15Rash144.3%
Literature
Recent PubMed references pinned to Choline as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Structural insights into a conserved mechanism of choline translocation through CHT.Science advances · 2026 · Vilchez-Garcia J, Martínez-Jiménez A, Jiang H, et al.PMID 42213839DOI 10.1126/sciadv.aec1241
- Choline and Choline-Related Metabolites in Pediatric Short Bowel Syndrome.Nutrients · 2026 · Hilberath J, Shunova A, Heister L, et al.PMID 42197014DOI 10.3390/nu18101553
- Blood Focused-Metabolomics and Transcriptomics Uncover Non-Linear Risk Association of Inadequate Dietary Choline Intake-Linked Metabolic Stress with MASLD Through Amino Acid Biomarkers, BCAA and MTORC 1/AKT1/IRS1 Mechanistic Mediators: A Nested Case-Control Study.International journal of molecular sciences · 2026 · Wu CH, Lin ML, Wang CY, et al.PMID 42196170DOI 10.3390/ijms27104186
- γ-Fe(2)O(3)/choline-tagged nanocellulose (ChNC) as a new bio-nanocomposite for tetracycline adsorptive removal and catalytic novel synthesis of pyrazolo-quinolinones.International journal of biological macromolecules · 2026 · Tamaddon F, Ahmadi-AhmadAbadi EPMID 42155751DOI 10.1016/j.ijbiomac.2026.152599
- Effect of tiomolibdate choline on copper balance in patients with Wilson disease: An open-label phase 2 trial.Hepatology communications · 2026 · Ala A, Sandahl TD, Weiss KH, et al.PMID 42155004DOI 10.1097/HC9.0000000000000971
- Association of Maternal and Cord Blood Choline and Betaine Concentrations with Birthweight: A Prospective Mother-Infant Cohort Study.Nutrients · 2026 · Aihemaitijiang S, Wen J, Li K, et al.PMID 42124057DOI 10.3390/nu18091456
- Lowered Maternal and Paternal Plasma Concentrations of Choline Are Associated with the Severity of Congenital Heart Defects in the Offspring.Nutrients · 2026 · Obeid R, Wagner A, Löhfelm C, et al.PMID 42124056DOI 10.3390/nu18091455
- The Mediterranean Diet and Cardiovascular Protection: Biochemical Mechanisms with Emphasis on Platelet-Activating Factor.Nutrients · 2026 · Detopoulou P, Antonopoulou S, Douvogianni P, et al.PMID 42123922DOI 10.3390/nu18091320
Clinical trials
The 10 most recently updated of 371 ClinicalTrials.gov registrations naming Choline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Citicoline in Youth Alcohol Use DisorderActive not recruiting · Phase 2 · Interventional · 56 enrolled · Medical University of South CarolinaNCT05870111updated 2026-06-12
- Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate BiopsiesTerminated · Interventional · 31 enrolled · Lille Catholic UniversityNCT02971995updated 2026-06-12
- Nutrition Supplement for Cystic FibrosisNot yet recruiting · Interventional · 60 enrolled · Ohio State UniversityNCT07163078updated 2026-06-09
- A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes MellitusRecruiting · Phase 2 · Interventional · 300 enrolled · Shanghai Jiao Tong University School of MedicineNCT07303803updated 2026-06-03
- Dairy Choline BioavailabilityNot yet recruiting · Interventional · 24 enrolled · University of Wisconsin, MadisonNCT06902480updated 2026-06-01
- Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple MyelomaCompleted · Phase 1 · Interventional · 22 enrolled · Mayo ClinicNCT04640779updated 2026-05-28
- PET TDM FDG-Choline as a Decision-making Tool for Routine Care on the Liver Transplant List for HCCActive not recruiting · Observational · 108 enrolled · University Hospital, LilleNCT04792801updated 2026-05-22
- Observational Study of VYKAT™ XR in Patients With Prader-Willi SyndromeEnrolling by invitation · Observational · 200 enrolled · Soleno Therapeutics, Inc.NCT07450664updated 2026-05-19
- Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral SupportRecruiting · Phase 2 · Phase 3 · Interventional · 129 enrolled · Protara TherapeuticsNCT06910943updated 2026-05-15
- Maternal Intake of Eggs and Infant NeurodevelopmentRecruiting · Interventional · 100 enrolled · University of Kansas Medical CenterNCT07583186updated 2026-05-13
Frequently asked questions
- How does Choline work?
- Mechanism-of-action class: Biological Macromolecular Activity.
- What is Choline used for?
- According to FDA labeling, Choline carries indications including: Uses temporarily relieves minor aches and pains due to: ○ headache ○ minor arthritis pain ○ muscle aches ○ menstrual cramps ○ backache temporarily reduces fever. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Choline?
- Choline is classified as Biological Macromolecular Activity, Cellular Activity Alteration.
choline 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.