Triclabendazole

Triclabendazole is an anthelmintic against Fasciola species [see Microbiology (12.4)] .

• EGATEN ® is indicated for the treatment of fascioliasis in patients 6 years of age and older. EGATEN ® tablet is an anthelmintic indicated for the treatment of fascioliasis in patients 6 years of age and older.

• EGATEN is contraindicated in patients with known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives or to any of the excipients in EGATEN. Patients with known hypersensitivity to triclabendazole, other benzimidazole derivatives or any of the excipients in EGATEN.contraindicated

The recommended dose of EGATEN is 2 doses of 10 mg/kg given 12 hours apart in patients 6 years of age and older. The 250 mg tablets are functionally scored and divisible into two equal halves of 125 mg. If the dosage cannot be adjusted exactly, round the dose upwards. Take EGATEN orally with food. EGATEN tablets can be swallowed whole or divided in half and taken with water or crushed and administered with applesauce. The crushed tablet mixed with applesauce is stable for up to 4 hours. The recommended dose of EGATEN is 2 doses of 10 mg/kg given 12 hours apart in patients 6 years of age and older. ( 2 ) Take orally with food. ( 2 ) Swallow tablets whole or divide in half and take with water, or crush and administer with applesauce. ( 2 ) If the dosage cannot be adjusted exactly, round dose upwards. ( 2 )

QT Prolongation : Prolongs QTc interval. Monitor electrocardiogram (ECG) in patients with a history of QTc prolongation or with electrolyte imbalance like hypokalemia or who are taking medications which prolong the QTc interval, or on CYP1A2 inhibitors, or have hepatic impairment. ( 5.1 ) 5.1 QT Prolongation EGATEN prolongs the QTc interval [see Clinical Pharmacology (12.2)] . The magnitude of QTc prolongation can increase with increasing treatment duration of EGATEN. Administration of EGATEN concurrently with CYP1A2 inhibitors and use in patients with hepatic impairment may result in increased exposures of triclabendazole and/or its metabolites, and, therefore, may increase the risk for QT prolongation. Monitor electrocardiogram (ECG) in patients with a history of prolongation of the QTc interval or a history of symptoms compatible with a long QT interval or with electrolyte imbalance like hypokalemia, or when EGATEN is used in patients who receive drugs that are known to prolong the QTc interval, or patients taking CYP1A2 inhibitors, or in patients with hepatic impairment. If signs of cardiac arrhythmia occur during treatment with EGATEN, stop the treatment and monitor ECG.

Most common adverse reactions (greater than 2%) with triclabendazole 20 mg/kg dose are abdominal pain, hyperhidrosis, nausea, decreased appetite, headache, urticaria, diarrhea, vomiting, musculoskeletal chest pain, and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of triclabendazole was evaluated in 208 adult and pediatric patients 5 years of age and older who participated in 6 clinical trials for the treatment of fascioliasis and received 10 mg/kg or 20 mg/kg of triclabendazole; of these, 6 patients failed the 10 mg/kg dose and were retreated with 20 mg/kg. The 10 mg/kg dosing regimen is not approved [see Dosage and Administration (2)] . In these trials, 186 patients received a single dose of 10 mg/kg and 28 patients received a dose of 20 mg/kg as two divided doses. Pooled data for adverse reactions reported in more than 2% of the patients in these clinical trials for the 10 mg/kg and 20 mg/kg dosing regimens are presented in Table 1. Table 1: Adverse Reactions Occurring in >2% of Patients Who Received a Total of 10 mg/kg or 20 mg/kg Triclabendazole for Fascioliasis Treatment (Pooled Across 6 Studies) 1 Divided doses were given 6-48 hours apart.

8.1 Pregnancy Risk Summary There are no available data on EGATEN use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Reproductive studies in animals (rat and rabbits) have not shown a risk of increased fetal abnormalities with exposure to triclabendazole during organogenesis at doses approximately 0.3 to 1.6 times the maximum recommended human dose (MRHD) of 20 mg/kg based on body surface area comparison (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data Embryo-fetal developmental toxicity studies revealed no malformations in rats and rabbits at doses up to 200 mg/kg/day and 20 mg/kg/day, respectively (approximately 1.6 times and 0.3 times the MRHD based on body surface area comparison, respectively). The animals were treated orally during organogenesis, starting on Day 6 of the pregnancy until Day 15 in rats and Day 18 in rabbits.

Metabolism

After oral administration of a single dose of 10 mg/kg triclabendazole with a 560-kcal meal to patients with fascioliasis, mean peak plasma concentrations (C max ) for triclabendazole, the sulfoxide and sulfone metabolites were 1.16, 38.6, and 2.29 μmol/L, respectively. The area under the curve (AUC) for triclabendazole, the sulfoxide and sulfone metabolites were 5.72, 386, and 30.5 μmol∙h/L, respectively.

The reported symptom of overdosage following ingestion of approximately 54 mg/kg of EGATEN (approximately 2.7 times the recommended dose) was nausea. The patient recovered following osmotic diuresis. In the event of overdose, monitor ECG and institute symptomatic treatment.

• Feb 13, 2019NDANDA208711Novartis

1. 1Malaise716%
2. 2Trematode Infection511%
3. 3Fascioliasis49.1%
4. 4Condition Aggravated36.8%
5. 5Illness36.8%
6. 6Nausea36.8%
7. 7Overdose36.8%
8. 8Rash36.8%
9. 9Abdominal Pain24.5%
10. 10Chest Pain24.5%
11. 11Cough24.5%
12. 12Diarrhoea24.5%
13. 13Drug Ineffective24.5%
14. 14Fatigue24.5%
15. 15Fracture24.5%

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

• Triclabendazole disrupts mitochondrial electron transport in vitro.
  Antimicrobial agents and chemotherapy · 2026 · Kämpfer T, Ancarola ME, Zumstein P, et al.
  PMID 42059379DOI 10.1128/aac.01756-25
• Efficacy of two triclabendazole regimens for treating human chronic fasciolosis and a controlled efficacy trial in sheep using human-isolate metacercariae in Cajamarca, Peru.
  Parasitology international · 2026 · Ortiz P, Hobán C, Murga-Moreno CA, et al.
  PMID 41936811DOI 10.1016/j.parint.2026.103277
• Resistance to triclabendazole in Fasciola hepatica on a commercial sheep farm in Taranaki, New Zealand.
  New Zealand veterinary journal · 2026 · Chapman V, Hassell C, Orbell G, et al.
  PMID 41610836DOI 10.1080/00480169.2026.2615096
• Integrative Study on Triclabendazole Stability: Forced Degradation and In Silico Toxicity Prediction of Degradation Products.
  Biomedical chromatography : BMC · 2026 · Pimpre K, Chaganti S, Khemchandani R, et al.
  PMID 41457442DOI 10.1002/bmc.70331
• Two analytical approaches for determination of amprolium and triclabendazole targeting their tertiary amino groups in waste water.
  Scientific reports · 2025 · Attia M, Salam RAA, Hadad GM, et al.
  PMID 41152401DOI 10.1038/s41598-025-22052-9
• Challenges in applying W.A.A.V.P. criteria to diagnosing triclabendazole resistance in Fasciola hepatica, an example from the Southern Tablelands of New South Wales, Australia.
  International journal for parasitology. Drugs and drug resistance · 2025 · Uthayakumar C, DeCristi HM, Francis EK, et al.
  PMID 41061298DOI 10.1016/j.ijpddr.2025.100618
• Triosephosphate isomerase from Fasciola hepatica: high-resolution crystal structure as a drug target.
  Acta crystallographica. Section F, Structural biology communications · 2025 · Kontellas G, Studholme DJ, van der Giezen M, et al.
  PMID 40832834DOI 10.1107/S2053230X25006454
• The effects of triclabendazole, combined tetramisole with Oxyclozanide, and albendazole against ovine fasciolosis.
  Scientific reports · 2025 · Gedefaw T, Mebratu AS, Dagnachew S, et al.
  PMID 40195337DOI 10.1038/s41598-025-90015-1

The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Triclabendazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis
  Not yet recruiting · Phase 2 · Interventional · 336 enrolled · Universidad Peruana Cayetano Heredia
  NCT06367361updated 2026-06-03
• Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older).
  Completed · Phase 4 · Interventional · 301 enrolled · Novartis Pharmaceuticals
  NCT04230148updated 2026-05-27
• Compassionate Use of Triclabendazole for the Treatment of Parasites (Prior to FDA Approval; Expanded Access Program)
  No longer available · Expanded access · University of Colorado, Denver
  NCT01931085updated 2021-05-04
• Impact IPT With Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine in Schoolchildren
  Completed · Phase 3 · Interventional · 616 enrolled · Universiteit Antwerpen
  NCT01722539updated 2014-02-04

Frequently asked questions

How does Triclabendazole work?

Triclabendazole is an anthelmintic against Fasciola species [see Microbiology (12.4)] .

What is Triclabendazole used for?

According to FDA labeling, Triclabendazole carries indications including: EGATEN ® is indicated for the treatment of fascioliasis in patients 6 years of age and older. EGATEN ® tablet is an anthelmintic indicated for the treatment of fascioliasis in patients 6 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Triclabendazole?

Triclabendazole is classified as Other antitrematodal agents, Anthelmintic, Cytochrome P450 1A2 Inhibitors, Cytochrome P450 2A6 Inhibitors, Cytochrome P450 2B6 Inhibitors, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 2C8 Inhibitors, Cytochrome P450 2C9 Inhibitors, Cytochrome P450 2D6 Inhibitors, Cytochrome P450 3A Inhibitors, Cytochrome P450 3A4 Inhibitors, Decreased Protein Synthesis, Microtubule Inhibition.

What are the brand names for Triclabendazole?

Triclabendazole is marketed under brand names including Egaten.

What are the contraindications for Triclabendazole?

Triclabendazole labeling lists contraindications including: EGATEN is contraindicated in patients with known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives or to any of the excipients in EGATEN. Patients with known hypersensitivity to triclabendazole, other benzimidazole derivatives or any of the excipients in EGATEN.. Always consult the full prescribing information and a clinician.