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

Details

Stereochemistry ABSOLUTE
Molecular Formula C10H10ClN5O2
Molecular Weight 267.672
Optical Activity UNSPECIFIED
Defined Stereocenters 1 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of CENOBAMATE

SMILES

NC(=O)O[C@@H](CN1N=CN=N1)C2=CC=CC=C2Cl

InChI

InChIKey=GFHAXPJGXSQLPT-VIFPVBQESA-N
InChI=1S/C10H10ClN5O2/c11-8-4-2-1-3-7(8)9(18-10(12)17)5-16-14-6-13-15-16/h1-4,6,9H,5H2,(H2,12,17)/t9-/m0/s1

HIDE SMILES / InChI
Molecular Formula C10H10ClN5O2
Molecular Weight 267.672
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 1 / 1
E/Z Centers 0
Optical Activity UNSPECIFIED

Description

Cenobamate (also known as YKP3089) is a small molecule sodium channel blocker in development for the treatment of partial-onset seizures in adult patients. In mice and rats, Cenobamate displayed an anticonvulsant activity in the maximal electroshock test and prevented seizures induced by chemical convulsants such as pentylenetetrazol and picrotoxin. In addition, Cenobamate was reported to be effective in two models of focal seizure, the hippocampal kindled rat and the mouse 6 Hz psychomotor seizure models. Two completed adequate and well-controlled clinical studies demonstrated a significant reduction in focal seizures with Cenobamate in patients with epilepsy, and a long-term open-label phase 3 safety clinical trial is currently ongoing. Cenobamate is considered a new generation antiepileptic therapy and clinical trials have shown that it may be more effective and safer than existing drugs. If licensed, Cenobamate will offer a new adjunctive treatment option for patients with partial focal epilepsy.

Originator

Approval Year

2019
334
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
0.1 μg/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
5 mg single, oral
dose: 5 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
4.42 μg/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
200 mg single, oral
dose: 200 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
17.2 μg/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
750 mg single, oral
dose: 750 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
24.1 μg/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
200 mg 1 times / day steady-state, oral
dose: 200 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
46.1 μg/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
400 mg 1 times / day steady-state, oral
dose: 400 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
4.53 μg × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
5 mg single, oral
dose: 5 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
322 μg × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
200 mg single, oral
dose: 200 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
1960 μg × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
750 mg single, oral
dose: 750 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
484 μg × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
200 mg 1 times / day steady-state, oral
dose: 200 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
873 μg × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
400 mg 1 times / day steady-state, oral
dose: 400 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
482 μg × h/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212839Orig1s000ClinPharmR.pdf
200 mg 1 times / day steady-state, oral
dose: 200 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
861 μg × h/mL
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212839Orig1s000ClinPharmR.pdf
400 mg 1 times / day steady-state, oral
dose: 400 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
35.9 h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
5 mg single, oral
dose: 5 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
54.7 h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
200 mg single, oral
dose: 200 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
75.6 h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/32087001/
750 mg single, oral
dose: 750 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
40%
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212839Orig1s000ClinPharmR.pdf
200 mg 1 times / day steady-state, oral
dose: 200 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
40%
OTHER GOV
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212839Orig1s000ClinPharmR.pdf
400 mg 1 times / day steady-state, oral
dose: 400 mg
route of administration: Oral
experiment type: STEADY-STATE
co-administered:
CENOBAMATE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Disc. AE: Tachycardia, Gastroesophageal reflux disease...
Other AEs: Somnolence, Dizziness...
AEs leading to
discontinuation/dose reduction:
Tachycardia
Gastroesophageal reflux disease
Drug hypersensitivity
Nystagmus
Aggression
Depression
Dyspnea
Other AEs:
Somnolence (grade 1-2, 22.1%)
Dizziness (grade 1-2, 22.1%)
Headache (grade 1-2, 12.4%)
Nausea (grade 1-2, 11.5%)
Fatigue (grade 1-2, 10.6%)
Nystagmus (grade 1-2, 9.7%)
Balance disorder (grade 1-2, 8%)
Urinary tract infection (grade 1-2, 8%)
Upper respiratory tract infection (grade 1-2, 7.1%)
Tremor (grade 1-2, 6.2%)
Nasopharyngitis (grade 1-2, 6.2%)
Constipation (grade 1-2, 5.3%)
Diarrhea (grade 1-2, 5.3%)
Vomiting (grade 1-2, 5.3%)
Anxiety (grade 1-2, 0.9%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Other AEs: Vertigo, Diplopia...
Other AEs:
Vertigo (1%)
Diplopia (6%)
Vision blurred (2%)
Nausea (6%)
Constipation (2%)
Diarrhea (1%)
Vomiting (2%)
Dry mouth (1%)
Abdominal pain (2%)
Dyspepsia (2%)
Nasopharyngitis (2%)
Pharyngitis (1%)
Urinary tract infection (2%)
Head injury (1%)
Alanine aminotransferase increased (1%)
Aspartate aminotransferase increased (1%)
Weight decreased (2%)
Decreased appetite (3%)
Back pain (4%)
Musculoskeletal chest pain (2%)
Somnolence (19%)
Dizziness (18%)
Fatigue (12%)
Headache (10%)
Balance disorder (3%)
Gait disturbance (1%)
Dysarthria (2%)
Nystagmus (3%)
Ataxia (2%)
Aphasia (2%)
Dysgeusia (2%)
Memory impairment (2%)
Sedation (1%)
Confusional state (2%)
Irritability (1%)
Suicidal ideation (2%)
Dysmenorrhea (1%)
Pruritus (2%)
Rash papular (2%)
ALT increased (0.9%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Other AEs: ALT increased...
Other AEs:
ALT increased (1.8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Other AEs: Vertigo, Diplopia...
Other AEs:
Vertigo (1%)
Diplopia (7%)
Vision blurred (2%)
Nausea (6%)
Constipation (4%)
Diarrhea (3%)
Vomiting (4%)
Dry mouth (1%)
Abdominal pain (2%)
Dyspepsia (2%)
Nasopharyngitis (4%)
Pharyngitis (2%)
Urinary tract infection (5%)
Alanine aminotransferase increased (1%)
Aspartate aminotransferase increased (1%)
Decreased appetite (1%)
Back pain (2%)
Musculoskeletal chest pain (1%)
Somnolence (22%)
Dizziness (22%)
Fatigue (14%)
Headache (12%)
Balance disorder (5%)
Gait disturbance (3%)
Dysarthria (1%)
Nystagmus (7%)
Ataxia (3%)
Aphasia (1%)
Memory impairment (1%)
Sedation (1%)
Confusional state (2%)
Suicidal ideation (1%)
Dysmenorrhea (2%)
Pruritus (1%)
Asthenia (1%)
Tremor (3%)
Pollakiuria (1%)
Hiccups (1%)
Dyspnea (3%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
350 mg 1 times / day steady, oral
Recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: steady
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Disc. AE: Ataxia, Dizziness...
AEs leading to
discontinuation/dose reduction:
Ataxia (>1)
Dizziness (>1)
Somnolence (>1)
Diplopia (>1)
Nystagmus (>1)
Vertigo (>1)
Cognitive deterioration (0.4%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Other AEs: Vertigo, Diplopia...
Other AEs:
Vertigo (6%)
Diplopia (15%)
Palpitations (2%)
Vision blurred (4%)
Nausea (9%)
Constipation (8%)
Diarrhea (5%)
Vomiting (5%)
Dry mouth (3%)
Abdominal pain (1%)
Nasopharyngitis (5%)
Head injury (2%)
Alanine aminotransferase increased (4%)
Aspartate aminotransferase increased (3%)
Weight decreased (1%)
Decreased appetite (5%)
Back pain (5%)
Somnolence (37%)
Dizziness (33%)
Fatigue (24%)
Headache (10%)
Balance disorder (9%)
Gait disturbance (8%)
Dysarthria (7%)
Nystagmus (6%)
Ataxia (6%)
Aphasia (4%)
Asthenia (3%)
Dysgeusia (2%)
Memory impairment (2%)
Migraine (2%)
Sedation (2%)
Tremor (1%)
Confusional state (3%)
Euphoric mood (2%)
Irritability (2%)
Dysmenorrhea (1%)
Hiccups (1%)
ALT increased (2.7%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
750 mg 1 times / day single, oral
Highest studied dose
Dose: 750 mg, 1 times / day
Route: oral
Route: single
Dose: 750 mg, 1 times / day
Sources:
http://az9194.vo.msecnd.net/pdfs/110404/11.08.pdf
https://pubmed.ncbi.nlm.nih.gov/32087001/
healthy
Health Status: healthy
Sex: M
Sources:
http://az9194.vo.msecnd.net/pdfs/110404/11.08.pdf
https://pubmed.ncbi.nlm.nih.gov/32087001/
Other AEs: Nervous system disorders...
Other AEs:
Nervous system disorders (71.4%)
Sources:
http://az9194.vo.msecnd.net/pdfs/110404/11.08.pdf
https://pubmed.ncbi.nlm.nih.gov/32087001/
AEs

AEs

AESignificanceDosePopulation
Aggression Disc. AE
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Depression Disc. AE
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Drug hypersensitivity Disc. AE
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Dyspnea Disc. AE
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Gastroesophageal reflux disease Disc. AE
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Nystagmus Disc. AE
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Tachycardia Disc. AE
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Anxiety grade 1-2, 0.9%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Fatigue grade 1-2, 10.6%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Nausea grade 1-2, 11.5%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Headache grade 1-2, 12.4%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Dizziness grade 1-2, 22.1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Somnolence grade 1-2, 22.1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Constipation grade 1-2, 5.3%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Diarrhea grade 1-2, 5.3%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Vomiting grade 1-2, 5.3%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Nasopharyngitis grade 1-2, 6.2%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Tremor grade 1-2, 6.2%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Upper respiratory tract infection grade 1-2, 7.1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Balance disorder grade 1-2, 8%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Urinary tract infection grade 1-2, 8%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
Nystagmus grade 1-2, 9.7%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
unhealthy, 18 to 65 years
Health Status: unhealthy
Age Group: 18 to 65 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/32409485/
ALT increased 0.9%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Alanine aminotransferase increased 1%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Aspartate aminotransferase increased 1%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Diarrhea 1%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dry mouth 1%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dysmenorrhea 1%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Gait disturbance 1%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Head injury 1%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Irritability 1%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Pharyngitis 1%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Sedation 1%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Vertigo 1%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Headache 10%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Fatigue 12%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dizziness 18%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Somnolence 19%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Abdominal pain 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Aphasia 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Ataxia 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Confusional state 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Constipation 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dysarthria 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dysgeusia 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dyspepsia 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Memory impairment 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Musculoskeletal chest pain 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Nasopharyngitis 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Pruritus 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Rash papular 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Suicidal ideation 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Urinary tract infection 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Vision blurred 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Vomiting 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Weight decreased 2%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Balance disorder 3%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Decreased appetite 3%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Nystagmus 3%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Back pain 4%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Diplopia 6%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Nausea 6%
100 mg 1 times / day steady, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: steady
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
ALT increased 1.8%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Alanine aminotransferase increased 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Aphasia 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Aspartate aminotransferase increased 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Asthenia 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Decreased appetite 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dry mouth 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dysarthria 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Hiccups 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Memory impairment 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Musculoskeletal chest pain 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Pollakiuria 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Pruritus 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Sedation 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Suicidal ideation 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Vertigo 1%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Headache 12%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Fatigue 14%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Abdominal pain 2%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Back pain 2%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Confusional state 2%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dysmenorrhea 2%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dyspepsia 2%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Pharyngitis 2%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Vision blurred 2%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dizziness 22%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Somnolence 22%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Ataxia 3%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Diarrhea 3%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dyspnea 3%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Gait disturbance 3%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Tremor 3%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Constipation 4%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Nasopharyngitis 4%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Vomiting 4%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Balance disorder 5%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Urinary tract infection 5%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Nausea 6%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Diplopia 7%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Nystagmus 7%
200 mg 1 times / day steady, oral
Recommended
Dose: 200 mg, 1 times / day
Route: oral
Route: steady
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Cognitive deterioration 0.4%
Disc. AE
350 mg 1 times / day steady, oral
Recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: steady
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Ataxia >1
Disc. AE
350 mg 1 times / day steady, oral
Recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: steady
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Diplopia >1
Disc. AE
350 mg 1 times / day steady, oral
Recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: steady
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dizziness >1
Disc. AE
350 mg 1 times / day steady, oral
Recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: steady
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Nystagmus >1
Disc. AE
350 mg 1 times / day steady, oral
Recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: steady
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Somnolence >1
Disc. AE
350 mg 1 times / day steady, oral
Recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: steady
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Vertigo >1
Disc. AE
350 mg 1 times / day steady, oral
Recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: steady
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Abdominal pain 1%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dysmenorrhea 1%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Hiccups 1%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Tremor 1%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Weight decreased 1%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Headache 10%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Diplopia 15%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dysgeusia 2%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Euphoric mood 2%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Head injury 2%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Irritability 2%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Memory impairment 2%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Migraine 2%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Palpitations 2%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Sedation 2%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
ALT increased 2.7%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Fatigue 24%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Aspartate aminotransferase increased 3%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Asthenia 3%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Confusional state 3%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dry mouth 3%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dizziness 33%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Somnolence 37%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Alanine aminotransferase increased 4%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Aphasia 4%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Vision blurred 4%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Back pain 5%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Decreased appetite 5%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Diarrhea 5%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Nasopharyngitis 5%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Vomiting 5%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Ataxia 6%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Nystagmus 6%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Vertigo 6%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Dysarthria 7%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Constipation 8%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Gait disturbance 8%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Balance disorder 9%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Nausea 9%
400 mg 1 times / day steady, oral
Recommended
Dose: 400 mg, 1 times / day
Route: oral
Route: steady
Dose: 400 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
unhealthy, mean age 39 years
Health Status: unhealthy
Age Group: mean age 39 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf
Nervous system disorders 71.4%
750 mg 1 times / day single, oral
Highest studied dose
Dose: 750 mg, 1 times / day
Route: oral
Route: single
Dose: 750 mg, 1 times / day
Sources:
http://az9194.vo.msecnd.net/pdfs/110404/11.08.pdf
https://pubmed.ncbi.nlm.nih.gov/32087001/
healthy
Health Status: healthy
Sex: M
Sources:
http://az9194.vo.msecnd.net/pdfs/110404/11.08.pdf
https://pubmed.ncbi.nlm.nih.gov/32087001/
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inducer
1087
inhibitor
2438

inducer
440
inhibitor
2507
inhibitor
2217

OverviewOther

Other InhibitorOther SubstrateOther Inducer
CYP2B6
926

CYP2C19
2057

CYP3A4/5
296

CYP1A2
2153

CYP2C8
1057

P-gp
1741

OAT1
725

OCT1
620

OCT2
779

OATP1B3
961

BSEP
550

OAT3
747

OATP1B1
1079
UGT2B7
456

UGT2B4
278

CYP2E1
729

CYP2A6
626

CYP2B6
776

CYP2C19
1119

CYP3A4/5
91

P-gp
2052

BCRP
697

OAT1
395

OAT3
391

OCT2
434

MATE1
182

MATE2
98
CYP2B6
669

CYP2C8
198

CYP1A2
832

CYP2C19
329
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
BSEP
554
 no
CYP1A2
2333
 no
CYP1A2
2333
 no
CYP2C19
2141
 no
CYP2C8
1117
 no
CYP2C9
2497
 no
CYP2C9
2497
 no
CYP2D6
2546
 no
OAT1
730
 no
OATP1B3
970
 no
OCT1
656
 no
OCT2
782
 no
P-gp
1932
 no
OAT3
749
 weak
OATP1B1
1095
 weak
CYP2C19
2141
 yes [IC50 170 uM]
yes (co-administration study)
Comment: Cenobamate increases exposure of phenytoin, omeprazole (CYP2C19 probe substrate) by approximately 2-fold when administered concomitantly
Page: 11.0
CYP2B6
1160
 yes [IC50 280 uM]
CYP3A4/5
357
 yes [IC50 720 uM]
CYP2B6
1160
 yes
CYP2C8
1117
 yes
CYP3A4
2633
 yes
yes (co-administration study)
Comment: Cendobamate decreases midazolam concentration upto 4-fold (CYP3A induction) when administered concomitantly.
Page: 11.0
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
UGT2B7
456
 major
BCRP
697
 no
MATE1
182
 no
MATE2
98
 no
OAT1
395
 no
OAT3
391
 no
OCT2
434
 no
P-gp
2052
 no
CYP2A6
626
 yes
CYP2B6
776
 yes
CYP2C19
1119
 yes
CYP2E1
729
 yes
CYP3A4/5
91
 yes
UGT2B4
278
 yes
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
2263
Sourcing

Sourcing

Vendor/AggregatorIDURL
Chem Scene
CS-0014686
http://www.chemscene.com/913088-80-9.html
DC Chemicals
Cenobamate
http://www.dcchemicals.com/product_show-DC11114.html
eNovation Chemicals
D673497
https://www.enovationchem.com/ProductDetails.asp?ProductID=D673497
Excenen
EX-A3604
https://www.excenen.com/searchresultlist.php?id=EX-A3604
Hairui
CECQ033
http://www.hairuichem.com/en/product/913088-80-9.html
MedChem Express
HY-17607
https://www.medchemexpress.com/Cenobamate.html
Molnova
M16559
MolPort
MolPort-047-786-375
https://www.molport.com/shop/molecule-link/MolPort-047-786-375
THE BioTek
bt-506132
https://www.thebiotek.com/product/others/bt-506132
ZINC
ZINC000116846024
http://zinc15.docking.org/substances/ZINC000116846024
PubMed

PubMed

TitleDatePubMed
Antiepileptic Drugs in Clinical Development: Differentiate or Die?
2017
Patents

Patents

20060258718
1
20110111467
1
7598279
1
WO2011046380A2
1

Sample Use Guides

In Vivo Use Guide
target dose of 200 mg/day
Route of Administration: Oral
Substance Class Chemical
Created
by admin
on Mon Mar 31 19:55:15 GMT 2025
Edited
by admin
on Mon Mar 31 19:55:15 GMT 2025
Record UNII
P85X70RZWS
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
cenobamate [INN]
Preferred Name English
CENOBAMATE
INN   USAN   WHO-DD  
INN   USAN  
Official Name English
2H-TETRAZOLE-2-ETHANOL, .ALPHA.-(2-CHLOROPHENYL)-, CARBAMATE (ESTER), (.ALPHA.R)-
Systematic Name English
YKP-3089
Code English
CARBAMIC ACID (R)-(+)-1-(2-CHLOROPHENYL)-2-(2H-TETRAZOL-2-YL)ETHYL ESTER
Systematic Name English
XCOPRI
Brand Name English
2H-TETRAZOLE-2-ETHANOL, .ALPHA.-(2-CHLOROPHENYL)-, 2-CARBAMATE, (.ALPHA.R)-
Systematic Name English
2H-TETRAZOLE-2-ETHANOL, ALPHA-(2-CHLOROPHENYL)-, YL)ETHYL)CARBAMATE CARBAMATE (ESTER), (.ALPHA.R)-
Systematic Name English
CENOBAMATE [ORANGE BOOK]
Common Name English
CENOBAMATE [USAN]
Common Name English
(1R)-1-(2-CHLOROPHENYL)-2-(TETRAZOL-YL)ETHYL)CARBAMATE
Common Name English
YKP3089
Code English
(1R)-1-(2-Chlorophenyl)-2-(2H-tetrazol-2-yl)ethyl carbamate
Systematic Name English
Cenobamate [WHO-DD]
Common Name English
CENOBAMATE [MI]
Common Name English
Classification Tree Code System Code
DEA NO. 2720
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
Code System Code Type Description
CAS
913088-80-9
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
NCI_THESAURUS
C174837
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
SMS_ID
100000174917
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
USAN
DE-83
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
DAILYMED
P85X70RZWS
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
FDA UNII
P85X70RZWS
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
DRUG CENTRAL
5355
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
DRUG BANK
DB06119
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
PUBCHEM
11962412
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
INN
10116
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
LACTMED
Cenobamate
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
MERCK INDEX
m12177
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
EPA CompTox
DTXSID001027948
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
WIKIPEDIA
Cenobamate
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
RXCUI
2265690
Created by admin on Mon Mar 31 19:55:15 GMT 2025 , Edited by admin on Mon Mar 31 19:55:15 GMT 2025
PRIMARY
Related Record Type Details
CYTOCHROME P450 2B6
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 3A4
METABOLIC ENZYME -> INHIBITOR
IC50
CYTOCHROME P450 2B6
METABOLIC ENZYME -> INHIBITOR
IC50
CYTOCHROME P450 2B6
METABOLIC ENZYME -> INDUCER
URIDINE DIPHOSPHATE GLUCURONOSYLTRANSFERASE 2B7
METABOLIC ENZYME -> SUBSTRATE
MAJOR
OAT-3
TRANSPORTER -> INHIBITOR
WEAK
CYTOCHROME P450 3A4
METABOLIC ENZYME -> INDUCER
Structure of CENOBAMATE
EXCRETED UNCHANGED
AMOUNT EXCRETED
URINE
CYTOCHROME P450 2C19
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 2C19
METABOLIC ENZYME -> INHIBITOR
IC50
CYTOCHROME P450 2E1
METABOLIC ENZYME -> SUBSTRATE
OATP1B1
TRANSPORTER -> INHIBITOR
WEAK
URIDINE DIPHOSPHATE GLUCURONOSYLTRANSFERASE 2B4
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 2A6
METABOLIC ENZYME -> SUBSTRATE
CYTOCHROME P450 3A4
METABOLIC ENZYME -> SUBSTRATE
GABAA RECEPTOR
TARGET->POSITIVE ALLOSTERIC MODULATOR (PAM)
CYTOCHROME P450 2C8
METABOLIC ENZYME -> INDUCER
PLASMA PROTEIN FRACTION (HUMAN)
BINDER->LIGAND
Cenobamate mainly binds with human albumin protein and not with ?1-acid glycoprotein.
BINDING
Related Record Type Details
Structure of (2S,3S,4S,5R,6R)-6-(((1R)-1-(2-CHLOROPHENYL)-2-(TETRAZOL-2-YL)ETHOXY)CARBONYLAMINO)-3,4,5-TRIHYDROXY-TETRAHYDROPYRAN-2-CARBOXYLIC ACID
METABOLITE -> PARENT
PLASMA
Structure of (2S,3S,4S,5R,6R)-6-((1R)-1-(2-CHLOROPHENYL)-2-(TETRAZOL-2-YL)ETHOXY)-3,4,5-TRIHYDROXY-TETRAHYDROPYRAN-2-CARBOXYLIC ACID
METABOLITE -> PARENT
URINE
Related Record Type Details
Structure of CENOBAMATE
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Biological Half-life PHARMACOKINETIC
Tmax PHARMACOKINETIC SINGLE- OR MULTIPLE-DOSE ADMINISTRATION

FASTED STATE

blood to plasma ratio PHARMACOKINETIC
Volume of Distribution PHARMACOKINETIC
NIH
NCATS
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