Trientine

Mechanism-of-action classes: Copper Chelating Activity; Metal Chelating Activity.

• Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined.

• Hypersensitivity to this product.contraindicated

Systemic evaluation of dose and/or interval between dose has not been done. However, on limited clinical experience, the recommended initial dose of trientine hydrochloride capsules is 500 to 750 mg/day for pediatric patients and 750 to 1,250 mg/day for adults given in divided doses two, three or four times daily. This may be increased to a maximum of 2,000 mg/day for adults or 1,500 mg/day for pediatric patients age 12 or under. The daily dose of trientine hydrochloride should be increased only when the clinical response is not adequate or the concentration of free serum copper is persistently above 20 mcg/dL. Optimal long-term maintenance dosage should be determined at 6 to 12 month intervals (see PRECAUTIONS , Laboratory Tests ). It is important that trientine hydrochloride capsules be given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed.

Patient experience with trientine hydrochloride is limited (see CLINICAL PHARMACOLOGY ). Patients receiving trientine hydrochloride should remain under regular medical supervision throughout the period of drug administration. Patients (especially women) should be closely monitored for evidence of iron deficiency anemia.

Clinical experience with trientine hydrochloride has been limited. The following adverse reactions have been reported in a clinical study in patients with Wilson's disease who were on therapy with trientine hydrochloride: iron deficiency, systemic lupus erythematosus (see CLINICAL PHARMACOLOGY ). In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis. Trientine hydrochloride is not indicated for treatment of biliary cirrhosis, but in one study of 4 patients treated with trientine hydrochloride for primary biliary cirrhosis, the following adverse reactions were reported: heartburn; epigastric pain and tenderness; thickening, fissuring and flaking of the skin; hypochromic microcytic anemia; acute gastritis; aphthoid ulcers; abdominal pain; melena; anorexia; malaise; cramps; muscle pain; weakness; rhabdomyolysis. A causal relationship of these reactions to drug therapy could not be rejected or established. To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions In general, mineral supplements should not be given since they may block the absorption of trientine hydrochloride. However, iron deficiency may develop, especially in children and menstruating or pregnant women, or as a result of the low copper diet recommended for Wilson's disease. If necessary, iron may be given in short courses, but since iron and trientine hydrochloride each inhibit absorption of the other, two hours should elapse between administration of trientine hydrochloride and iron. It is important that trientine hydrochloride be taken on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. This permits maximum absorption and reduces the likelihood of inactivation of the drug by metal binding in the gastrointestinal tract.

Metabolism

Data on the pharmacokinetics of trientine hydrochloride are not available. Dosage adjustment recommendations are based upon clinical use of the drug (see DOSAGE AND ADMINISTRATION ).

There is a report of an adult woman who ingested 30 grams of trientine hydrochloride without apparent ill effects. No other data on overdosage are available.

• Nov 8, 1985NDANDA019194Bausch
• Jan 16, 2019ANDAANDA211251Navinta Llc
• May 22, 2019ANDAANDA211134Msn
• Jul 3, 2019ANDAANDA211076Dr Reddys
• Sep 25, 2019ANDAANDA210096Ph Health
• Feb 20, 2020ANDAANDA212238Rising
• Apr 28, 2022NDANDA215760Orphalan
• Jun 23, 2022ANDAANDA216356Hetero Labs Ltd Iii

1. 1Off Label Use7316%
2. 2Product Dose Omission Issue6915%
3. 3Treatment Noncompliance316.8%
4. 4Nausea275.9%
5. 5Drug Dose Omission194.2%
6. 6Therapy Interrupted173.7%
7. 7Fatigue153.3%
8. 8Product Storage Error153.3%
9. 9Abdominal Discomfort132.8%
10. 10Abdominal Pain Upper132.8%
11. 11Hospitalisation132.8%
12. 12Tremor132.8%
13. 13Condition Aggravated122.6%
14. 14Drug Ineffective122.6%
15. 15Abdominal Pain112.4%

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

• Evaluation of novel assays of non-ceruloplasmin copper to monitor chelation treatment in patients with Wilson disease.
  JHEP reports : innovation in hepatology · 2026 · Ott P, Sandahl T, Ala A, et al.
  PMID 41831608DOI 10.1016/j.jhepr.2026.101822
• Trientine ameliorates bleomycin-induced pulmonary fibrosis in rats through copper chelation and modulation of the CTR1/LOX/COL pathway.
  Inflammopharmacology · 2026 · Khalil IT, Elshal M, Elsayed NM, et al.
  PMID 41784930DOI 10.1007/s10787-026-02135-3
• New insights into the effects of dissolution profiles on the pharmacokinetics of trientine dihydrochloride.
  European journal of clinical pharmacology · 2025 · Weiss KH, Kruse C, Abd-Elaziz K, et al.
  PMID 41428007DOI 10.1007/s00228-025-03961-0
• Safety of penicillamine and trientine in the treatment of Wilson's disease: An analysis of the FDA Adverse Event Reporting System (FAERS) database.
  PloS one · 2025 · Qian W, Xu K, Li S, et al.
  PMID 41223192DOI 10.1371/journal.pone.0336721
• Synergistic removal of lead and zinc ions from the wastewater by cross-linked carbamate starch-g-triethylenetetramine in the presence of sodium butyl xanthate.
  International journal of biological macromolecules · 2025 · Yang Y, Wu Y, Zhang S, et al.
  PMID 41197697DOI 10.1016/j.ijbiomac.2025.148730
• Triethylenetetramine functionalized tannic acid/sodium alginate composite aerogel and its adsorption performance of Cu(2+) and Pb(2).
  International journal of biological macromolecules · 2025 · Li H, Wang X, Zhang S, et al.
  PMID 41077211DOI 10.1016/j.ijbiomac.2025.148181
• Towards an Analytical Procedure Control Strategy for the Capillary Zone Electrophoresis Method for Monoclonal Antibodies: Alternatives for ε-Aminocaproic Acid and Triethylenetetramine.
  Electrophoresis · 2025 · Baxter J, Fitton L, Sänger-van de Griend CE, et al.
  PMID 40988426DOI 10.1002/elps.70038
• Room-temperature one-step synthesis of amine-functionalized lignin with ultra-high nitrogen content for efficient adsorption of Hg(II) and Congo red from wastewater.
  Bioresource technology · 2025 · Chen J, Li M, Cai Y, et al.
  PMID 40759343DOI 10.1016/j.biortech.2025.133069

The 10 most recently updated of 22 ClinicalTrials.gov registrations naming Trientine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.
  Not yet recruiting · Phase 3 · Interventional · 38 enrolled · Orphalan
  NCT07465718updated 2026-05-28
• Real World Evidence Study in Subjects With Wilson's Disease
  Completed · Observational · 50 enrolled · Orphalan
  NCT05783687updated 2026-04-06
• Patient Preference Study: Standard of Care Versus Once-daily Trientine Tetrahydrochloride
  Completed · Phase 2 · Interventional · 10 enrolled · Orphalan
  NCT07010575updated 2026-04-06
• Off Treatment Urinary Copper Excretion in Wilson Disease, Pilot Study
  Recruiting · Observational · 30 enrolled · Yale University
  NCT07301216updated 2026-03-05
• Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
  Recruiting · Observational · 30 enrolled · Hospices Civils de Lyon
  NCT06430359updated 2026-01-15
• The Efficacy and Mechanism of Trientine in Patients With Hypertrophic Cardiomyopathy
  Completed · Phase 2 · Interventional · 154 enrolled · Manchester University NHS Foundation Trust
  NCT04706429updated 2025-09-29
• Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).
  Completed · Phase 1 · Interventional · 26 enrolled · Orphalan
  NCT06128954updated 2025-08-15
• International Wilson's Disease Patient Registry (iWilson Registry)
  Recruiting · Observational · 500 enrolled · Orphalan
  NCT05239858updated 2025-07-03
• Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease
  Completed · Phase 3 · Interventional · 77 enrolled · Orphalan
  NCT03539952updated 2025-07-02
• Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease
  Terminated · Phase 3 · Interventional · 40 enrolled · Alexion Pharmaceuticals, Inc.
  NCT05047523updated 2024-10-23

Frequently asked questions

How does Trientine work?

Mechanism-of-action classes: Copper Chelating Activity; Metal Chelating Activity.

What is Trientine used for?

According to FDA labeling, Trientine carries indications including: Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Trientine?

Trientine is classified as Various alimentary tract and metabolism products, Copper Chelator, Copper Chelating Activity, Metal Chelating Activity, Increased Renal Ion Excretion.

What are the brand names for Trientine?

Trientine is marketed under brand names including Cuvrior, Syprine.

What are the contraindications for Trientine?

Trientine labeling lists contraindications including: Hypersensitivity to this product.. Always consult the full prescribing information and a clinician.