U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ACHIRAL
Molecular Formula C14H9Cl3N2OS
Molecular Weight 359.6595
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of TRICLABENDAZOLE

SMILES

CSc1[nH]c2cc(c(cc2n1)Oc3cccc(c3Cl)Cl)Cl

InChI

InChIKey=NQPDXQQQCQDHHW-UHFFFAOYSA-N
InChI=1S/C14H9Cl3N2OS/c1-21-14-18-9-5-8(16)12(6-10(9)19-14)20-11-4-2-3-7(15)13(11)17/h2-6H,1H3,(H,18,19)

HIDE SMILES / InChI
Molecular Formula C14H9Cl3N2OS
Molecular Weight 359.6595
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Description
Curator's Comment:: https://www.drugs.com/international/triclabendazole.html | https://www.drugs.com/mmx/triclabendazole.html | https://www.ncbi.nlm.nih.gov/pubmed/15259481 | https://www.ncbi.nlm.nih.gov/pubmed/26312936

Triclabendazole, (brand name Avomec, Egaten, etc) is a member of the benzimidazole family of anthelmintics used to treat liver flukes, specifically fascioliasis and paragonimiasis. Triclabendazole used routinely since 1983 in veterinary practice for the treatment of fascioliasis. It was not used in humans until the 1989 epidemic of fascioliasis near the Caspian Sea when Iranian authorities approved the use of the veterinary formulation to treat the infection. Fasciolicidal not only against the adult worms present in the biliary ducts, but also against the immature larval stages of Fasciola migrating through the hepatic parenchyma. Triclabendazole is shown to penetrate into liver flukes by transtegumentary absorption followed by inhibition of the parasite's motility, probably related to the destruction of the microtubular structure, resulting in the death of the parasite; the immobilizing effect is paralleled by changes in the parasite's resting tegumental membrane potential, strongly inhibiting the release of proteolytic enzymes, a process that appears critical to the survival of the parasite. Side effects are generally few, but can include abdominal pain and headaches. Biliary colic may occur due to dying worms. While no harms have been found with use during pregnancy, triclabendazole has not been well studied in this population. Triclabendazole is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. It is not commercially available in the United States.

Originator

Approval Year

2019
98
Targets

Targets

Primary TargetPharmacologyConditionPotency
Inhibitor
7701
Parasitic disease
 15 µM [IC50]
Inhibitor
7701
Inhibitor
7701
Fascioliasis
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Curative
Cruzipain
Approved
7997
Egaten
Curative
Fasciola hepatica
Approved
7997
Egaten
Curative
Approved
7997
Egaten
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
0.34 μM
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/9663817/
10 mg/kg 1 times / day multiple, oral
dose: 10 mg/kg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
TRICLABENDAZOLE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1.16 μM
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/9663817/
10 mg/kg 1 times / day multiple, oral
dose: 10 mg/kg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
TRICLABENDAZOLE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FED
1.16 μM
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
10 mg/kg single, oral
dose: 10 mg/kg
route of administration: Oral
experiment type: SINGLE
co-administered:
TRICLABENDAZOLE plasma
Homo sapiens
population: UNHEALTHY
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
1.55 μM × h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/9663817/
10 mg/kg 1 times / day multiple, oral
dose: 10 mg/kg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
TRICLABENDAZOLE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
5.72 μM × h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/9663817/
10 mg/kg 1 times / day multiple, oral
dose: 10 mg/kg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
TRICLABENDAZOLE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FED
5.72 μM × h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
10 mg/kg single, oral
dose: 10 mg/kg
route of administration: Oral
experiment type: SINGLE
co-administered:
TRICLABENDAZOLE plasma
Homo sapiens
population: UNHEALTHY
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
8 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
10 mg/kg single, oral
dose: 10 mg/kg
route of administration: Oral
experiment type: SINGLE
co-administered:
TRICLABENDAZOLE plasma
Homo sapiens
population: UNHEALTHY
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
3.3%
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
10 mg/kg single, oral
dose: 10 mg/kg
route of administration: Oral
experiment type: SINGLE
co-administered:
TRICLABENDAZOLE plasma
Homo sapiens
population: UNHEALTHY
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 12-60 years
Health Status: unhealthy
Age Group: 12-60 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Other AEs: Abdominal pain, Headache...
Other AEs:
Abdominal pain (6.4%)
Headache (10.6%)
Dizziness (4.3%)
Jaundice (2.1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 4-68 years
Health Status: unhealthy
Age Group: 4-68 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Other AEs: Dizziness, Abdominal pain...
Other AEs:
Dizziness (5.4%)
Abdominal pain (1.3%)
Diarrhea (1.3%)
Fever (1.9%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 5-54 years
Health Status: unhealthy
Age Group: 5-54 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Other AEs: Headache, Abdominal pain...
Other AEs:
Headache (5.7%)
Abdominal pain (5.7%)
Vomiting (2.9%)
Diarrhea (2.9%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
10 mg/kg 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
Other AEs: Abdominal pain, Biliary colic...
Other AEs:
Abdominal pain (grade 3, 1.2%)
Biliary colic (grade 1-2, 49%)
Jaundice (grade 1-2, 7.2%)
Epigastric pain (grade 1-2, 42.7%)
Nausea (grade 1-2, 8.5%)
Fever (grade 1-2, 8.5%)
Pruritus (grade 1-2, 6.1%)
Urticaria (grade 1-2, 2.4%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
10 mg/kg 2 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Other AEs: Abdominal pain, Hyperhidrosis...
Other AEs:
Abdominal pain (93%)
Hyperhidrosis (25%)
Nausea (18%)
Urticaria (11%)
Vomiting (7%)
Headache (14%)
Pruritus (4%)
Musculoskeletal chest pain (4%)
Decreased appetite (18%)
Diarrhea (7%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
15 mg/kg single, oral
Recommended
Dose: 15 mg/kg
Route: oral
Route: single
Dose: 15 mg/kg
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Other AEs: Bilirubin increased, AST increased...
Other AEs:
Bilirubin increased (6.8%)
AST increased (4.5%)
Alkaline phosphatase increased (4.2%)
ALT increased (3%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Other AEs: Urticaria, Nausea...
Other AEs:
Urticaria (7%)
Nausea (8%)
Abdominal pain (56%)
Hyperhidrosis (23%)
Vertigo (9%)
Vomiting (6%)
Headache (6%)
Dyspnea (5%)
Pruritus (4%)
Asthenia (4%)
Musculoskeletal chest pain (4%)
Cough (4%)
Decreased appetite (3%)
Chest pain (3%)
Pyrexia (2%)
Jaundice (2%)
Chest discomfort (2%)
Constipation (< 2%)
Biliary colic (< 2%)
Arthralgia (< 2%)
Back pain (< 2%)
Spinal pain (< 2%)
Chromaturia (< 2%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
10 mg/kg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age 16.3 years
Health Status: unhealthy
Age Group: mean age 16.3 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Other AEs: Abdominal pain, Fatigue...
Other AEs:
Abdominal pain (grade 1, 100%)
Fatigue (grade 1, 50%)
Headache (grade 1-2, 75%)
Diarrhea (grade 1, 25%)
Nausea (grade 1, 75%)
Vomiting (grade 1, 25%)
Fever (grade 1-2, 25%)
Dizziness (grade 1, 50%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age14.4 years
Health Status: unhealthy
Age Group: mean age14.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Other AEs: Abdominal pain, Fatigue...
Other AEs:
Abdominal pain (grade 1-2)
Fatigue (grade 1)
Headache (grade 1-2)
Diarrhea (grade 1-2)
Vomiting (grade 1)
Fever (grade 1-2)
Dizziness (grade 1)
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
AEs

AEs

AESignificanceDosePopulation
Headache 10.6%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 12-60 years
Health Status: unhealthy
Age Group: 12-60 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Jaundice 2.1%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 12-60 years
Health Status: unhealthy
Age Group: 12-60 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Dizziness 4.3%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 12-60 years
Health Status: unhealthy
Age Group: 12-60 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Abdominal pain 6.4%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 12-60 years
Health Status: unhealthy
Age Group: 12-60 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Abdominal pain 1.3%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 4-68 years
Health Status: unhealthy
Age Group: 4-68 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Diarrhea 1.3%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 4-68 years
Health Status: unhealthy
Age Group: 4-68 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Fever 1.9%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 4-68 years
Health Status: unhealthy
Age Group: 4-68 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Dizziness 5.4%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 4-68 years
Health Status: unhealthy
Age Group: 4-68 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Diarrhea 2.9%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 5-54 years
Health Status: unhealthy
Age Group: 5-54 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Vomiting 2.9%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 5-54 years
Health Status: unhealthy
Age Group: 5-54 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Abdominal pain 5.7%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 5-54 years
Health Status: unhealthy
Age Group: 5-54 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Headache 5.7%
10 mg/kg 1 times / 8 hours multiple, oral
Dose: 10 mg/kg, 1 times / 8 hours
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / 8 hours
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
unhealthy, 5-54 years
Health Status: unhealthy
Age Group: 5-54 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208711Orig1s000MultidisciplineR.pdf
Urticaria grade 1-2, 2.4%
10 mg/kg 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
Epigastric pain grade 1-2, 42.7%
10 mg/kg 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
Biliary colic grade 1-2, 49%
10 mg/kg 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
Pruritus grade 1-2, 6.1%
10 mg/kg 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
Jaundice grade 1-2, 7.2%
10 mg/kg 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
Fever grade 1-2, 8.5%
10 mg/kg 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
Nausea grade 1-2, 8.5%
10 mg/kg 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
Abdominal pain grade 3, 1.2%
10 mg/kg 1 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/11421375/
Urticaria 11%
10 mg/kg 2 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Headache 14%
10 mg/kg 2 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Decreased appetite 18%
10 mg/kg 2 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Nausea 18%
10 mg/kg 2 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Hyperhidrosis 25%
10 mg/kg 2 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Musculoskeletal chest pain 4%
10 mg/kg 2 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Pruritus 4%
10 mg/kg 2 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Diarrhea 7%
10 mg/kg 2 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Vomiting 7%
10 mg/kg 2 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Abdominal pain 93%
10 mg/kg 2 times / day multiple, oral
Recommended
Dose: 10 mg/kg, 2 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
ALT increased 3%
15 mg/kg single, oral
Recommended
Dose: 15 mg/kg
Route: oral
Route: single
Dose: 15 mg/kg
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Alkaline phosphatase increased 4.2%
15 mg/kg single, oral
Recommended
Dose: 15 mg/kg
Route: oral
Route: single
Dose: 15 mg/kg
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
AST increased 4.5%
15 mg/kg single, oral
Recommended
Dose: 15 mg/kg
Route: oral
Route: single
Dose: 15 mg/kg
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Bilirubin increased 6.8%
15 mg/kg single, oral
Recommended
Dose: 15 mg/kg
Route: oral
Route: single
Dose: 15 mg/kg
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Chest discomfort 2%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Jaundice 2%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Pyrexia 2%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Hyperhidrosis 23%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Chest pain 3%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Decreased appetite 3%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Asthenia 4%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Cough 4%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Musculoskeletal chest pain 4%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Pruritus 4%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Dyspnea 5%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Abdominal pain 56%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Headache 6%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Vomiting 6%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Urticaria 7%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Nausea 8%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Vertigo 9%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Arthralgia < 2%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Back pain < 2%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Biliary colic < 2%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Chromaturia < 2%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Constipation < 2%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Spinal pain < 2%
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
unhealthy, adult | children
Health Status: unhealthy
Age Group: adult | children
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208711s000lbl.pdf
Abdominal pain grade 1, 100%
10 mg/kg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age 16.3 years
Health Status: unhealthy
Age Group: mean age 16.3 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Diarrhea grade 1, 25%
10 mg/kg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age 16.3 years
Health Status: unhealthy
Age Group: mean age 16.3 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Vomiting grade 1, 25%
10 mg/kg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age 16.3 years
Health Status: unhealthy
Age Group: mean age 16.3 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Dizziness grade 1, 50%
10 mg/kg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age 16.3 years
Health Status: unhealthy
Age Group: mean age 16.3 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Fatigue grade 1, 50%
10 mg/kg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age 16.3 years
Health Status: unhealthy
Age Group: mean age 16.3 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Nausea grade 1, 75%
10 mg/kg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age 16.3 years
Health Status: unhealthy
Age Group: mean age 16.3 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Fever grade 1-2, 25%
10 mg/kg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age 16.3 years
Health Status: unhealthy
Age Group: mean age 16.3 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Headache grade 1-2, 75%
10 mg/kg 1 times / day multiple, oral
Highest studied dose
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: multiple
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age 16.3 years
Health Status: unhealthy
Age Group: mean age 16.3 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Dizziness grade 1
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age14.4 years
Health Status: unhealthy
Age Group: mean age14.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Fatigue grade 1
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age14.4 years
Health Status: unhealthy
Age Group: mean age14.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Vomiting grade 1
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age14.4 years
Health Status: unhealthy
Age Group: mean age14.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Abdominal pain grade 1-2
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age14.4 years
Health Status: unhealthy
Age Group: mean age14.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Diarrhea grade 1-2
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age14.4 years
Health Status: unhealthy
Age Group: mean age14.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Fever grade 1-2
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age14.4 years
Health Status: unhealthy
Age Group: mean age14.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Headache grade 1-2
10 mg/kg 1 times / day single, oral
Dose: 10 mg/kg, 1 times / day
Route: oral
Route: single
Dose: 10 mg/kg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
unhealthy, mean age14.4 years
Health Status: unhealthy
Age Group: mean age14.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/21909440/
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inhibitor
1318

substrate
865
inhibitor
1421

substrate
1038

OverviewOther

Other InhibitorOther SubstrateOther Inducer
CYP1A2
1268

CYP2B6
679

CYP2C8
761

CYP2C19
1215

CYP3A
175

CYP2E1
761

BCRP
574
CYP1A2
892

CYP2C19
830

CYP3A
154

FMO
29

CYP1A1
302

CYP1B1
82

CYP2C18
143

UGT1A4
295

UGT1A8
242

UGT1A9
327

P-gp
1223
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
CYP2E1
841
 no
CYP2E1
841
 no
TCBZ-SO
1
CYP2E1
841
 no
TCBZ-SO2
1
CYP2D6
1455
 yes [Ki 0.009 uM]
CYP2B6
845
 yes [Ki 0.016 uM]
CYP2C8
810
 yes [Ki 0.018 uM]
CYP2D6
1455
 yes [Ki 0.05 uM]
TCBZ-SO
1
CYP2C9
1362
 yes [Ki 0.053 uM]
CYP2C19
1277
 yes [Ki 0.061 uM]
CYP1A2
1406
 yes [Ki 0.149 uM]
TCBZ-SO
1
CYP3A
244
 yes [Ki 0.166 uM]
CYP2C9
1362
 yes [Ki 0.22 uM]
TCBZ-SO2
1
CYP2C8
810
 yes [Ki 0.37 uM]
TCBZ-SO2
1
CYP2C19
1277
 yes [Ki 0.57 uM]
TCBZ-SO
1
CYP2B6
845
 yes [Ki 0.75 uM]
TCBZ-SO
1
CYP2C8
810
 yes [Ki 1.03 uM]
TCBZ-SO
1
CYP2B6
845
 yes [Ki 1.27 uM]
TCBZ-SO2
1
CYP2C9
1362
 yes [Ki 1.81 uM]
TCBZ-SO
1
CYP1A2
1406
 yes [Ki 12.5 uM]
TCBZ-SO2
1
CYP2D6
1455
 yes [Ki 13 uM]
TCBZ-SO2
1
CYP3A
244
 yes [Ki 2.31 uM]
TCBZ-SO2
1
CYP2C19
1277
 yes [Ki 2.77 uM]
TCBZ-SO2
1
CYP3A
244
 yes [Ki 4.32 uM]
TCBZ-SO
1
BCRP
639
 yes
BCRP
639
 yes
TCBZ-SO
1
BCRP
639
 yes
TCBZ-SO2
1
CYP1A2
1406
 yes
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
CYP1A1
302
 yes
CYP1A1
302
 yes
TCBZ-SO
1
CYP1A2
892
 yes
CYP1A2
892
 yes
TCBZ-SO
1
CYP1B1
82
 yes
CYP1B1
82
 yes
TCBZ-SO
1
CYP2C18
143
 yes
CYP2C19
830
 yes
CYP2C19
830
 yes
TCBZ-SO
1
CYP2C9
865
 yes
CYP2D6
1038
 yes
CYP3A
154
 yes
FMO
29
 yes
FMO
29
 yes
TCBZ-SO
1
P-gp
1223
 yes
UGT1A4
295
 yes
UGT1A8
242
 yes
UGT1A9
327
 yes
Sourcing

Sourcing

Vendor/AggregatorIDURL
001 Chemical
NO19265
1PlusChem LLC
1P006HM9
A2B Chem
AD01969
AA Blocks
AA006H2T
AK Scientific
I018
AK Scientific
J10510
AK Scientific
J92245
APExBIO
B1860
AbovChem LLC
HY-B0621
Achemo BB
AC-14758
Alfa Chemistry
ACM68786663
Alinda
IBS-0006535
Ambeed
A206752
Angene
AGN-PC-0WAFFY
AstaTech
O11577
BLDpharm
BD34628
BOC Sciences
68786-66-3
Bide Pharmatech
BD34628
BioBlocks
A3375/0143230
BlocksMatrix Scientific
76003
Cayman Chemical
18883
Chem Scene
CS-2859
ChemBridge
6962480
ChemDiv
8015-3230
Combi-Blocks
QA-9111
Combi-Blocks
QB-6689
Compound Cloud
50248
Fluorochem
79305
Fragmenta
BEN631
Hangzhou APIChem Technology
AC-7627
IBScreen
Bio-0402
KeyOrganics
KS-5329
Lab Network
LN00176318
Lab Seeker
SC-17720
MedChem Express
HY-B0621
MolPort
MolPort-000-705-689
MolPort
MolPort-002-230-021
Molcore
CS19265
Molnova
M15626
Norris Pharm
NSZB-A280532
Oakwood
79305
PI Chemicals
PI-12425
Pharmeks
PHAR011857
Princeton BioMolecular Research
OSSL_052792
Ryan Scientific
Pregnenolone
Selleck Chemicals
S4114
Sigma Aldrich
32802
Sigma Aldrich
32802|SIAL
Sigma Aldrich
Y0001723
Sigma Aldrich
Y0001723|SIAL
Sigma Aldrich
Y0001737
Sigma Aldrich
Y0001737|SIAL
StruChem
SC-17720
Tetrahedron
TS16826
TimTec
ST4095348
Toronto Research Chemicals
T774175
Vitas-M Laboratory
STK332284
W&J PharmaChem
50C990048
Wonderchem
WD06KR4
ZINC
ZINC000001444556
http://zinc15.docking.org/substances/ZINC000001444556
Zelinsky Institute
UZI/2630612
eMolecules
2425535
eMolecules
902621
eNovation Chemicals
D480544
mcule
MCULE-8131756770
PubMed

PubMed

TitleDatePubMed
[A clinical trial of triclabendazole in the treatment of human paragonimiasis skrjabini].
2001
The biochemical basis of anthelmintic action and resistance.
2001 Apr
Effect of fasciolicides on the antigenaemia in sheep naturally infected with Fasciola hepatica.
2001 Aug
Efficacy of combined chemotherapy against gastrointestinal nematodes and Fasciola hepatica in cattle.
2001 Aug 20
An experimental study on triclabendazole resistance of Fasciola hepatica in sheep.
2001 Feb
Imported Fasciola hepatica infection in the United States and treatment with triclabendazole.
2001 Jul 1
[Stomach ache and fever after consumption of watercress in Turkey: fascioliasis].
2001 Sep 29
A comparative study on the effect of praziquantel and triclabendazole on Vampirolepis nana in vitro.
2002 Apr
Fasciola gigantica: tegumental surface alterations following treatment in vitro with the sulphoxide metabolite of triclabendazole.
2002 Apr
Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises. Case 12-2002. A 50-year-old man with eosinophilia and fluctuating hepatic lesions.
2002 Apr 18
[Chilhood hepatic fascioliasis treated with triclabendazol].
2002 Aug
Pathological and immunohistochemical study of the liver and hepatic lymph nodes of sheep chronically reinfected with Fasciola hepatica, with or without triclabendazole treatment.
2002 Jul
A praziquantel-ineffective fascioliasis case successfully treated with triclabendazole.
2002 Jun
Triclabendazole-resistant Fasciola hepatica: beta-tubulin and response to in vitro treatment with triclabendazole.
2002 Mar
Synthesis and fasciolicidal activity of 5-chloro-2-methylthio-6-(1-naphthyloxy)-1H-benzimidazole.
2002 May
Development and validation of a liquid chromatographic-electrospray tandem mass spectrometric multiresidue method for anthelmintics in milk.
2002 Nov 8
Effects of three anthelmintic treatment regimes against Fasciola and nematodes on the performance of ewes and lambs on pasture in the highlands of Kenya.
2002 Oct
Fasciola hepatica infestation with joint symptoms.
2003 Feb
Pre-exposure of cattle to drug-abbreviated Fasciola hepatica infections: the effect upon subsequent challenge infection and the early immune response.
2003 Jan 20
Pediatric fascioliasis: report of three cases.
2003 Jan-Mar
Triclabendazole in the treatment of Paragonimiasis skrjabini.
2003 Nov
Clastogenic effects of the fasciolicide drug fasinex on river buffalo lymphocyte cultures in vitro.
2003 Nov 10
The effect of metronidazole in treating human fascioliasis.
2003 Oct
Human infection by Fasciola hepatica in Venezuela: report of a geriatric case.
2003 Sep
The effect of the microtubule inhibitor tubulozole-C on the tegument of triclabendazole-susceptible and triclabendazole-resistant Fasciola hepatica.
2003 Sep
Field trial on the efficacy of an experimental fasciolicide compared with some commercial compounds in naturally infected cattle.
2003 Sep
Chemotherapy for major food-borne trematodes: a review.
2004 Aug
Liver, spleen, pancreas and kidney involvement by human fascioliasis: imaging findings.
2004 Aug 4
Response of two isolates of Fasciola hepatica to treatment with triclabendazole in vivo and in vitro.
2004 Dec
Comparative assessment of the access of albendazole, fenbendazole and triclabendazole to Fasciola hepatica: effect of bile in the incubation medium.
2004 Jan
Human fascioliasis.
2004 May
Randomized trial of a single, double and triple dose of 10 mg/kg of a human formulation of triclabendazole in patients with fascioliasis.
2004 Nov
Fascioliasis imported to Norway.
2005
Triclabendazole for the treatment of fascioliasis and paragonimiasis.
2005 Dec
Separation and characterization of synthetic impurities of triclabendazole by reversed-phase high-performance liquid chromatography/electrospray ionization mass spectrometry.
2005 Feb 7
Eurytrema pancreaticum: the in vitro effect of praziquantel and triclabendazole on the adult fluke.
2005 Nov
Emerging foodborne trematodiasis.
2005 Oct
Altered drug influx/efflux and enhanced metabolic activity in triclabendazole-resistant liver flukes.
2005 Oct
Treatment of fascioliasis in human infections.
2006 Feb
Eight cases of fascioliasis: clinical and microbiological features.
2006 Jan
[Hepatobiliary fasciolasis without eosinophilia].
2006 Oct
[New drugs against parasitic diseases].
2007 Jan 31
Food-borne trematodiasis: current chemotherapy and advances with artemisinins and synthetic trioxolanes.
2007 Nov
[Fascioliasis: a 23-year retrospective study].
2007 Nov
Patents

Patents

BE865870
1
DE2815621
1
NL7803886
1

Sample Use Guides

In Vivo Use Guide
10 mg per kg of body weight as a single dose
Route of Administration: Oral
In Vitro Use Guide
Triclabendazole was tested in vitro against recently excysted metacercariae. Triclabendazole was evaluated at concentrations of 10 and 50 mg/L., Triclabendazole demonstrated a fasciolicidal efficacy of 100% at a concentration of 10 and 50 mg/L at 24, 48 h and 72 hours post-treatment
Substance Class Chemical
Created
by admin
on Fri Jun 25 22:13:15 UTC 2021
Edited
by admin
on Fri Jun 25 22:13:15 UTC 2021
Record UNII
4784C8E03O
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
TRICLABENDAZOLE
INN   MART.   MI  
USAN   INN  
Official Name English
1H-BENZIMIDAZOLE, 6-CHLORO-5-(2,3-DICHLOROPHENOXY)-2-(METHYLTHIO)-
Systematic Name English
NVP-EGA230
Code English
TRICLABENDAZOLE [MART.]
Common Name English
TRICLABENDAZOLE [ORANGE BOOK]
Common Name English
EGATEN
Brand Name English
TRICLABENDAZOLE [INN]
Common Name English
EGA230B
Code English
TRICLABENDAZOLE [MI]
Common Name English
5-CHLORO-6-(2,3-DICHLOROPHENOXY)-2-(METHYLTHIO)-1H-BENZIMIDAZOLE
Systematic Name English
TRICLABENDAZOLE [WHO-DD]
Common Name English
FASINEX
Brand Name English
TRICLABENDAZOLE [USAN]
Common Name English
NSC-759250
Code English
Classification Tree Code System Code
WHO-VATC QP52AC01
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
WHO-ATC P02BX04
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
FDA ORPHAN DRUG 564216
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
WHO-ESSENTIAL MEDICINES LIST 6.1.3
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
NCI_THESAURUS C250
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
FDA ORPHAN DRUG 525416
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
Code System Code Type Description
CAS
68786-66-3
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
EVMPD
SUB11267MIG
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
NCI_THESAURUS
C75236
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
MERCK INDEX
M11087
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY Merck Index
MESH
C039276
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
DRUG CENTRAL
2734
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
EPA CompTox
68786-66-3
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
RXCUI
2118525
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
LACTMED
Triclabendazole
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
FDA UNII
4784C8E03O
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
DRUG BANK
DB12245
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
ChEMBL
CHEMBL1086440
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
PUBCHEM
50248
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
INN
5003
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
WIKIPEDIA
TRICLABENDAZOLE
Created by admin on Fri Jun 25 22:13:16 UTC 2021 , Edited by admin on Fri Jun 25 22:13:16 UTC 2021
PRIMARY
Related Record Type Details
CYTOCHROME P450 1A2
METABOLIC ENZYME -> SUBSTRATE
MAJOR
CYTOCHROME P450 2C19
METABOLIC ENZYME -> SUBSTRATE
FETAL HEPATIC FLAVIN-CONTAINING MONOOXYGENASE 1 (HUMAN)
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 2B6
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 2D6
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 1A2
METABOLIC ENZYME -> INHIBITOR
CYTOCHROME P450 3A4
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 2C8
METABOLIC ENZYME -> SUBSTRATE
PLASMA PROTEIN FRACTION (HUMAN)
BINDER->LIGAND
BINDING
CYTOCHROME P450 2C9
METABOLIC ENZYME -> SUBSTRATE
FASCIOLA HEPATICA
TARGET ORGANISM->INHIBITOR
CYTOCHROME P450 2C19
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 2C9
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 2A6
METABOLIC ENZYME -> INHIBITOR
CYTOCHROME P450 2D6
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 3A4
METABOLIC ENZYME -> SUBSTRATE
FASCIOLA GIGANTICA
TARGET ORGANISM->INHIBITOR
CYTOCHROME P450 1A1
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 1B1
METABOLIC ENZYME -> SUBSTRATE
FETAL HEPATIC FLAVIN-CONTAINING MONOOXYGENASE 3 (HUMAN)
METABOLIC ENZYME -> SUBSTRATE
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Structure of TRICLABENDAZOLE SULFOXIDE
METABOLITE ACTIVE -> PARENT
MAJOR
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Structure of 5-CHLORO-6-(2,3-DICHLOROPHENOXY)-1H-BENZIMIDAZOLE-2-THIOL
METABOLITE -> PARENT
Related Record Type Details
Structure of TRICLABENDAZOLE SULFOXIDE
IMPURITY -> PARENT
FOR VETERINARY USE
CHROMATOGRAPHIC PURITY (HPLC/UV)
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Structure of 4-CHLORO-5-(2,3-DICHLOROPHENOXY)-2-NITROANILINE
IMPURITY -> PARENT
FOR VETERINARY USE
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Structure of 5-CHLORO-6-(2,3-DICHLOROPHENOXY)-1H-BENZIMIDAZOLE-2-THIOL
IMPURITY -> PARENT
FOR VETERINARY USE
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
Related Record Type Details
Structure of TRICLABENDAZOLE
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Volume of Distribution PHARMACOKINETIC
Tmax PHARMACOKINETIC ORAL ADMINISTRATION

Biological Half-life PHARMACOKINETIC
NIH
NCATS
PRIVACY ACT
ACCESSIBILITY
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