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Details

Stereochemistry ACHIRAL
Molecular Formula C23H27Cl2N3O2
Molecular Weight 448.385
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of ARIPIPRAZOLE

SMILES

ClC1=C(Cl)C(=CC=C1)N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2

InChI

InChIKey=CEUORZQYGODEFX-UHFFFAOYSA-N
InChI=1S/C23H27Cl2N3O2/c24-19-4-3-5-21(23(19)25)28-13-11-27(12-14-28)10-1-2-15-30-18-8-6-17-7-9-22(29)26-20(17)16-18/h3-6,8,16H,1-2,7,9-15H2,(H,26,29)

HIDE SMILES / InChI

Molecular Formula C23H27Cl2N3O2
Molecular Weight 448.385
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Description
Curator's Comment: Description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/12784105/, https://www.ncbi.nlm.nih.gov/pubmed/12587943, https://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0000157/

Aripiprazole is the first next-generation atypical antipsychotic. The unique actions of aripiprazole in humans are likely a combination of "functionally selective" activation of D(2) (and possibly D(3))-dopamine receptors and serotonin 5-HT(1A) receptors, coupled with inhibition of 5-HT(2A) receptors. Aripiprazole was approved by FDA (Abilify trade name) for the treatment of schizophrenia; manic and mixed episodes associated with bipolar I disorder; major depressive disorder; irritability associated with autistic disorder; Tourette’s disorder and agitation associated with schizophrenia or bipolar mania.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
ABILIFY

Approved Use

ABILIFY is an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia, Acute Treatment of Manic and Mixed Episodes associated with Bipolar I, Adjunctive Treatment of Major Depressive Disorder, Irritability Associated with Autistic Disorder, Treatment of Tourette’s disorder, The injection is indicated for: Agitation associated with schizophrenia or bipolar mania

Launch Date

2002
Primary
ABILIFY

Approved Use

ABILIFY is an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia, Acute Treatment of Manic and Mixed Episodes associated with Bipolar I, Adjunctive Treatment of Major Depressive Disorder, Irritability Associated with Autistic Disorder, Treatment of Tourette’s disorder, The injection is indicated for: Agitation associated with schizophrenia or bipolar mania

Launch Date

2002
Primary
ABILIFY

Approved Use

ABILIFY is an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia, Acute Treatment of Manic and Mixed Episodes associated with Bipolar I, Adjunctive Treatment of Major Depressive Disorder, Irritability Associated with Autistic Disorder, Treatment of Tourette’s disorder, The injection is indicated for: Agitation associated with schizophrenia or bipolar mania

Launch Date

2002
Primary
ABILIFY

Approved Use

ABILIFY is an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia, Acute Treatment of Manic and Mixed Episodes associated with Bipolar I, Adjunctive Treatment of Major Depressive Disorder, Irritability Associated with Autistic Disorder, Treatment of Tourette’s disorder, The injection is indicated for: Agitation associated with schizophrenia or bipolar mania

Launch Date

2002
Primary
ABILIFY

Approved Use

ABILIFY is an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia, Acute Treatment of Manic and Mixed Episodes associated with Bipolar I, Adjunctive Treatment of Major Depressive Disorder, Irritability Associated with Autistic Disorder, Treatment of Tourette’s disorder, The injection is indicated for: Agitation associated with schizophrenia or bipolar mania

Launch Date

2002
Primary
ABILIFY

Approved Use

ABILIFY is an atypical antipsychotic indicated as oral formulations for the: Treatment of schizophrenia (1.1) Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1) Acute treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy and as an adjunct to lithium or valproate (1.2) Adults: Efficacy was established in four 3-week monotherapy trials and one 6-week adjunctive trial in patients with manic or mixed episodes (14.2) Pediatric Patients (ages 10-17): Efficacy was established in one 4-week monotherapy trial in patients with manic or mixed episodes (14.2) Maintenance treatment of bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate (1.2) Adults: Efficacy was established in one maintenance monotherapy trial and in one maintenance adjunctive trial (14.2) Adjunctive treatment of major depressive disorder (MDD) (1.3) Adults: Efficacy was established in two 6-week trials in patients with MDD who had an inadequate response to antidepressant therapy during the current episode (14.3) Treatment of irritability associated with autistic disorder (1.4) Pediatric Patients (ages 6-17 years): Efficacy was established in two 8-week trials in patients with autistic disorder (14.4) as an injection for the: Acute treatment of agitation associated with schizophrenia or bipolar I disorder (1.5) Adults: Efficacy was established in three 24-hour trials in agitated patients with schizophrenia or manic/mixed episodes of bipolar I disorder (14.5) 1.1 Schizophrenia ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY was established in four 4-6 week trials in adults and one 6-week trial in adolescents (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents [see CLINICAL STUDIES (14.1)

Launch Date

2002
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
163 ng/mL
10 mg 1 times / day multiple, oral
dose: 10 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
ARIPIPRAZOLE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
2947 ng × h/mL
10 mg 1 times / day multiple, oral
dose: 10 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
ARIPIPRAZOLE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
52.9 h
10 mg 1 times / day multiple, oral
dose: 10 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
ARIPIPRAZOLE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
1%
10 mg 1 times / day multiple, oral
dose: 10 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
ARIPIPRAZOLE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
30 mg 1 times / day multiple, oral
Highest studied dose
Dose: 30 mg, 1 times / day
Route: oral
Route: multiple
Dose: 30 mg, 1 times / day
Sources:
unhealthy, 10-17 years
Health Status: unhealthy
Age Group: 10-17 years
Sex: M+F
Sources:
Other AEs: Abdominal pain upper, Vomiting...
Other AEs:
Abdominal pain upper (17%)
Vomiting (17%)
Dizziness (17%)
Headache (50%)
Sedation (33%)
Somnolence (17%)
Sources:
2 mg single, intravenous
Dose: 2 mg
Route: intravenous
Route: single
Dose: 2 mg
Sources:
healthy, 35 years (range: 18-45 years)
Health Status: healthy
Age Group: 35 years (range: 18-45 years)
Sex: M+F
Sources:
45 mg single, intramuscular
Highest studied dose
Dose: 45 mg
Route: intramuscular
Route: single
Dose: 45 mg
Sources:
unhealthy, 39 years (range: 18-65 years)
Health Status: unhealthy
Age Group: 39 years (range: 18-65 years)
Sex: M+F
Sources:
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Other AEs: Vomiting, Somnolence...
Other AEs:
Vomiting
Somnolence
Tremor
Acidosis
Aggression
Aspartate aminotransferase increased
Atrial fibrillation
Coma
Confusional state
Convulsion
Blood creatine phosphokinase increased
Depressed level of consciousness
Hypertension
Hypokalemia
Hypotension
Lethargy
Loss of consciousness
QT prolonged
Aspiration pneumonia
Respiratory arrest
Status epilepticus
Tachycardia
Sources:
10 mg 1 times / day steady, oral
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Other AEs: Extrapyramidal disorder, Neuroleptic malignant syndrome...
Other AEs:
Extrapyramidal disorder (serious, 1 patient)
Neuroleptic malignant syndrome (serious, 1 patient)
Aggression (serious, 1 patient)
Schizophrenia (serious, 1 patient)
Nausea (below serious, 9 patients)
Nasopharyngitis (below serious, 5 patients)
Dizziness (below serious, 7 patients)
Extrapyramidal disorder (below serious, 13 patients)
Headache (below serious, 16 patients)
Somnolence (below serious, 11 patient)
Sources:
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Other AEs: Varicella, Depression...
Other AEs:
Varicella (serious, 1 patient)
Depression (serious, 1 patient)
Schizophrenia (serious, 1 patient)
Suicidal ideation (serious, 1 patient)
Thrombophlebitis (serious, 1 patient)
Nausea (below serious, 10 patients)
Nasopharyngitis (below serious, 5 patients)
Dizziness (below serious, 4 patients)
Extrapyramidal disorder (below serious, 22 patients)
Headache (below serious, 11 patient)
Somnolence (below serious, 22 patients)
Tremor (below serious, 12 patients)
Sources:
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Other AEs: Vomiting, Somnolence...
Other AEs:
Vomiting
Somnolence
Tremor
Acidosis
Aggression
Aspartate aminotransferase increased
Atrial fibrillation
Coma
Confusional state
Convulsion
Blood creatine phosphokinase increased
Depressed level of consciousness
Hypertension
Hypokalemia
Hypotension
Lethargy
Loss of consciousness
QT prolonged
Aspiration pneumonia
Respiratory arrest
Status epilepticus
Tachycardia
Sources:
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Other AEs: Adverse event...
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Other AEs: Constipation, Diarrhea...
Other AEs:
Constipation (below serious, 8 patients)
Diarrhea (below serious, 7 patients)
Nausea (below serious, 2 patients)
Abdominal discomfort (below serious, 7 patients)
Vomiting (below serious, 15 patients)
Decreased appetite (below serious, 12 patients)
Increased appetite (below serious, 16 patients)
Drowsiness (below serious, 5 patients)
Tiredness (below serious, 21 patient)
Fever (below serious, 3 patients)
Weight gain (below serious, 8 patients)
Muscle rigidity (below serious, 3 patients)
Tremor (below serious, 3 patients)
Nervousness (below serious, 3 patients)
Repetitive speech (below serious, 3 patients)
Restlessness (below serious, 3 patients)
Feeling sad (below serious, 3 patients)
Self injurious behavior (below serious, 3 patients)
Enuresis (below serious, 3 patients)
Dizziness (below serious, 4 patients)
Nose bleed (below serious, 3 patients)
Sources:
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Other AEs: Abdominal pain, Bruising...
Other AEs:
Abdominal pain (below serious, 7 patients)
Bruising (below serious, 2 patients)
Constipation (below serious, 6 patients)
Diarrhea (below serious, 9 patients)
Dizziness (below serious, 5 patients)
Dry mouth (below serious, 6 patients)
Enuresis (below serious, 5 patients)
Headache (below serious, 6 patients)
Insomnia (below serious, 8 patients)
Malaise (below serious, 7 patients)
Mucosal ulceration (below serious, 4 patients)
Nausea (below serious, 10 patients)
Restlessness (below serious, 5 patients)
Sedation (below serious, 7 patients)
Tinnitus (below serious, 7 patients)
Tremor (below serious, 8 patients)
Vomiting (below serious, 10 patients)
Weight loss (below serious, 4 patients)
Sources:
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Other AEs: Restlessness, Decreased activity...
Other AEs:
Restlessness (below serious, 2 patients)
Decreased activity (below serious, 1 patient)
Drowsiness (below serious, 2 patients)
Vertigo (below serious, 1 patient)
Cold extremities (below serious, 1 patient)
Blurred vision (below serious, 2 patients)
Sexual disorder NOS (below serious, 2 patients)
Joint stiffness (below serious, 1 patient)
Sources:
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Other AEs: Rhabdomyolysis, Pneumonia...
Other AEs:
Rhabdomyolysis (serious, 1 patient)
Pneumonia (serious, 1 patient)
Cellulitis (serious, 1 patient)
Abrasions (below serious, 3 patients)
Akathisia (below serious, 12 patients)
Drowsiness (below serious, 6 patients)
Fatigue (below serious, 8 patients)
Depressed mood (below serious, 3 patients)
Hypernatremia (below serious, 4 patients)
Hypocalcemia (below serious, 3 patients)
ALT increased (below serious, 8 patients)
Aspartate aminotransferase increased (below serious, 6 patients)
Restlessness (below serious, 4 patients)
Sleep disturbance (below serious, 3 patients)
Infection upper respiratory (below serious, 6 patients)
Sources:
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Other AEs: Suicidal ideation, Gun shot wound...
Other AEs:
Suicidal ideation (serious, 2 patients)
Gun shot wound (serious, 1 patient)
Injury (serious, 1 patient)
Multiple injuries (serious, 1 patient)
Diabetes mellitus (serious, 1 patient)
Hyperglycaemia (serious, 1 patient)
Pancreatic carcinoma (serious, 1 patient)
Hallucination, auditory (serious, 1 patient)
Suicide attempt (serious, 1 patient)
Headache (below serious, 16 patients)
Insomnia (below serious, 27 patients)
Tremor (below serious, 16 patients)
Sources:
AEs

AEs

AESignificanceDosePopulation
Abdominal pain upper 17%
30 mg 1 times / day multiple, oral
Highest studied dose
Dose: 30 mg, 1 times / day
Route: oral
Route: multiple
Dose: 30 mg, 1 times / day
Sources:
unhealthy, 10-17 years
Health Status: unhealthy
Age Group: 10-17 years
Sex: M+F
Sources:
Dizziness 17%
30 mg 1 times / day multiple, oral
Highest studied dose
Dose: 30 mg, 1 times / day
Route: oral
Route: multiple
Dose: 30 mg, 1 times / day
Sources:
unhealthy, 10-17 years
Health Status: unhealthy
Age Group: 10-17 years
Sex: M+F
Sources:
Somnolence 17%
30 mg 1 times / day multiple, oral
Highest studied dose
Dose: 30 mg, 1 times / day
Route: oral
Route: multiple
Dose: 30 mg, 1 times / day
Sources:
unhealthy, 10-17 years
Health Status: unhealthy
Age Group: 10-17 years
Sex: M+F
Sources:
Vomiting 17%
30 mg 1 times / day multiple, oral
Highest studied dose
Dose: 30 mg, 1 times / day
Route: oral
Route: multiple
Dose: 30 mg, 1 times / day
Sources:
unhealthy, 10-17 years
Health Status: unhealthy
Age Group: 10-17 years
Sex: M+F
Sources:
Sedation 33%
30 mg 1 times / day multiple, oral
Highest studied dose
Dose: 30 mg, 1 times / day
Route: oral
Route: multiple
Dose: 30 mg, 1 times / day
Sources:
unhealthy, 10-17 years
Health Status: unhealthy
Age Group: 10-17 years
Sex: M+F
Sources:
Headache 50%
30 mg 1 times / day multiple, oral
Highest studied dose
Dose: 30 mg, 1 times / day
Route: oral
Route: multiple
Dose: 30 mg, 1 times / day
Sources:
unhealthy, 10-17 years
Health Status: unhealthy
Age Group: 10-17 years
Sex: M+F
Sources:
Acidosis
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Aggression
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Aspartate aminotransferase increased
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Aspiration pneumonia
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Atrial fibrillation
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Blood creatine phosphokinase increased
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Coma
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Confusional state
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Convulsion
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Depressed level of consciousness
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Hypertension
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Hypokalemia
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Hypotension
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Lethargy
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Loss of consciousness
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
QT prolonged
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Respiratory arrest
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Somnolence
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Status epilepticus
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Tachycardia
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Tremor
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Vomiting
195 mg single, oral
Overdose
Dose: 195 mg
Route: oral
Route: single
Dose: 195 mg
Sources:
unhealthy, < 12 years
Health Status: unhealthy
Age Group: < 12 years
Sources:
Somnolence below serious, 11 patient
10 mg 1 times / day steady, oral
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Extrapyramidal disorder below serious, 13 patients
10 mg 1 times / day steady, oral
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Headache below serious, 16 patients
10 mg 1 times / day steady, oral
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Nasopharyngitis below serious, 5 patients
10 mg 1 times / day steady, oral
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Dizziness below serious, 7 patients
10 mg 1 times / day steady, oral
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Nausea below serious, 9 patients
10 mg 1 times / day steady, oral
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Aggression serious, 1 patient
10 mg 1 times / day steady, oral
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Extrapyramidal disorder serious, 1 patient
10 mg 1 times / day steady, oral
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Neuroleptic malignant syndrome serious, 1 patient
10 mg 1 times / day steady, oral
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Schizophrenia serious, 1 patient
10 mg 1 times / day steady, oral
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Nausea below serious, 10 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Headache below serious, 11 patient
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Tremor below serious, 12 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Extrapyramidal disorder below serious, 22 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Somnolence below serious, 22 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Dizziness below serious, 4 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Nasopharyngitis below serious, 5 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Depression serious, 1 patient
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Schizophrenia serious, 1 patient
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Suicidal ideation serious, 1 patient
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Thrombophlebitis serious, 1 patient
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Varicella serious, 1 patient
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
unhealthy, adolescent
Health Status: unhealthy
Age Group: adolescent
Sources:
Acidosis
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Aggression
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Aspartate aminotransferase increased
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Aspiration pneumonia
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Atrial fibrillation
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Blood creatine phosphokinase increased
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Coma
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Confusional state
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Convulsion
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Depressed level of consciousness
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Hypertension
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Hypokalemia
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Hypotension
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Lethargy
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Loss of consciousness
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
QT prolonged
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Respiratory arrest
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Somnolence
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Status epilepticus
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Tachycardia
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Tremor
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Vomiting
1080 mg single, oral
Overdose
Dose: 1080 mg
Route: oral
Route: single
Dose: 1080 mg
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Adverse event grade 5
10 mg 1 times / day steady, oral
Recommended
Dose: 10 mg, 1 times / day
Route: oral
Route: steady
Dose: 10 mg, 1 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Decreased appetite below serious, 12 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Vomiting below serious, 15 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Increased appetite below serious, 16 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Nausea below serious, 2 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Tiredness below serious, 21 patient
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Enuresis below serious, 3 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Feeling sad below serious, 3 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Fever below serious, 3 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Muscle rigidity below serious, 3 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Nervousness below serious, 3 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Nose bleed below serious, 3 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Repetitive speech below serious, 3 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Restlessness below serious, 3 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Self injurious behavior below serious, 3 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Tremor below serious, 3 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Dizziness below serious, 4 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Drowsiness below serious, 5 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Abdominal discomfort below serious, 7 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Diarrhea below serious, 7 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Constipation below serious, 8 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Weight gain below serious, 8 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy, children
Health Status: unhealthy
Age Group: children
Sources:
Nausea below serious, 10 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Vomiting below serious, 10 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Bruising below serious, 2 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Mucosal ulceration below serious, 4 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Weight loss below serious, 4 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Dizziness below serious, 5 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Enuresis below serious, 5 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Restlessness below serious, 5 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Constipation below serious, 6 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Dry mouth below serious, 6 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Headache below serious, 6 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Abdominal pain below serious, 7 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Malaise below serious, 7 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Sedation below serious, 7 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Tinnitus below serious, 7 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Insomnia below serious, 8 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Tremor below serious, 8 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Diarrhea below serious, 9 patients
15 mg 1 times / day steady, oral
Dose: 15 mg, 1 times / day
Route: oral
Route: steady
Dose: 15 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sex: F
Sources:
Cold extremities below serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Decreased activity below serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Joint stiffness below serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Vertigo below serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Blurred vision below serious, 2 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Drowsiness below serious, 2 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Restlessness below serious, 2 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Sexual disorder NOS below serious, 2 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Akathisia below serious, 12 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Abrasions below serious, 3 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Depressed mood below serious, 3 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Hypocalcemia below serious, 3 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Sleep disturbance below serious, 3 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Hypernatremia below serious, 4 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Restlessness below serious, 4 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Aspartate aminotransferase increased below serious, 6 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Drowsiness below serious, 6 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Infection upper respiratory below serious, 6 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
ALT increased below serious, 8 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Fatigue below serious, 8 patients
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Cellulitis serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Pneumonia serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Rhabdomyolysis serious, 1 patient
20 mg 1 times / day steady, oral
Dose: 20 mg, 1 times / day
Route: oral
Route: steady
Dose: 20 mg, 1 times / day
Sources:
unhealthy
Health Status: unhealthy
Sources:
Headache below serious, 16 patients
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Tremor below serious, 16 patients
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Insomnia below serious, 27 patients
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Diabetes mellitus serious, 1 patient
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Gun shot wound serious, 1 patient
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Hallucination, auditory serious, 1 patient
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Hyperglycaemia serious, 1 patient
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Injury serious, 1 patient
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Multiple injuries serious, 1 patient
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Pancreatic carcinoma serious, 1 patient
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Suicide attempt serious, 1 patient
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
Suicidal ideation serious, 2 patients
400 mg 1 times / 4 weeks steady, oral
Dose: 400 mg, 1 times / 4 weeks
Route: oral
Route: steady
Dose: 400 mg, 1 times / 4 weeks
Sources:
unhealthy
Health Status: unhealthy
Sources:
OverviewDrug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
not significant
unlikely (co-administration study)
Comment: aripiprazole had no effect ont the PK of omeprazole
Page: 43.0
not significant
unlikely (co-administration study)
Comment: aripiprazole had no effect on the PK of warfarin
Page: 43.0
not significant
unlikely (co-administration study)
Comment: aripiprazole had no effect on the PK of of dextromethorphan
Page: 43.0
not significant
unlikely (co-administration study)
Comment: aripiprazole had no effect on the PK of of dextromethorphan
Page: 43.0
not significant
yes [IC50 1.2 uM]
yes [IC50 3.5 uM]
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
no
no
no
no
no
no
no
no
no
yes
yes
yes (co-administration study)
Comment: Coadministration of aripiprazole with quinidine, a potent inhibitor of CYP2D6, increased the AUC of aripiprazole by 112% but decreased the AUC of its active metabolite, dehydroaripiprazole, by 35%; PHARMACOGENOMIC STUDY: 82% increase in aripiprazole systemic exposure in CYP2D6 PM compared to EM, net increase of aripiprazole exposure is greater than 60%, total body clearance of aripiprazole in PM decreased by 40%, not adequately studied in PM patients;
Page: 29.0
yes
yes (co-administration study)
Comment: Coadministration of ketoconazole increased the AUC of aripiprazole and its active metabolite by 63% and 77%, respectively; Coadministration of carbamazepine, a potent CYP3A4 inducer, resulted in an approximate 70% decrease in Cmax and AUC values of both aripiprazole and its active metabolite, dehydro-aripiprazole;
Page: 29.0
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
PubMed

PubMed

TitleDatePubMed
Interactions of the novel antipsychotic aripiprazole (OPC-14597) with dopamine and serotonin receptor subtypes.
1999 Jun
Nonconserved residues in the second transmembrane-spanning domain of the D(4) dopamine receptor are molecular determinants of D(4)-selective pharmacology.
2000 Jan
In vivo canine model comparison of cardiohemodynamic and electrophysiological effects of a new antipsychotic drug aripiprazole (OPC-14597) to haloperidol.
2001 Jun 1
Dopamine system stabilizers, aripiprazole, and the next generation of antipsychotics, part 1, "Goldilocks" actions at dopamine receptors.
2001 Nov
Advances in atypical antipsychotics for the treatment of schizophrenia: new formulations and new agents.
2002
Aripiprazole. Abilitat, OPC 14597.
2002
The antipsychotic aripiprazole is a potent, partial agonist at the human 5-HT1A receptor.
2002 Apr 26
Gateways to clinical trials.
2002 Dec
Aripiprazole (Otsuka Pharmaceutical Co).
2002 Jan
Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors.
2002 Jul
Partial dopamine agonists in the treatment of psychosis.
2002 Mar
Psychotropic drugs and the ECG: focus on the QTc interval.
2002 May
Similarities and differences among antipsychotics.
2003
Choice of maintenance medication for schizophrenia.
2003
New developments in the pharmacotherapy of schizophrenia.
2003
Treatment for mood and anxiety disorders: quetiapine and aripiprazole.
2003 Aug
Medication developments in the treatment of mental illness.
2003 Dec
Relationship of atypical antipsychotics with development of diabetes mellitus.
2003 Dec
Efficacy and safety of aripiprazole vs. haloperidol for long-term maintenance treatment following acute relapse of schizophrenia.
2003 Dec
Aripiprazole.
2003 Dec 1
Gateways to clinical trials.
2003 Jan-Feb
Characterization of the 5-HT6 receptor coupled to Ca2+ signaling using an enabling chimeric G-protein.
2003 Jul 4
Gateways to clinical trials.
2003 Jun
Aripiprazole.
2003 Jun
Chlorpromazine equivalent doses for the newer atypical antipsychotics.
2003 Jun
Serotonin receptors: their key role in drugs to treat schizophrenia.
2003 Oct
Aripiprazole for the prevention of relapse in stabilized patients with chronic schizophrenia: a placebo-controlled 26-week study.
2003 Sep
Dopamine partial agonists: a new class of antipsychotic.
2004
Gateways to clinical trials.
2004 Apr
Aripiprazole (OPC-14597) fully substitutes for the 5-HT1A receptor agonist LY293284 in the drug discrimination assay in rats.
2004 Apr
The novel antipsychotic aripiprazole is a partial agonist at short and long isoforms of D2 receptors linked to the regulation of adenylyl cyclase activity and prolactin release.
2004 Apr 2
Pharmacogenomic-guided rational therapeutic drug monitoring: conceptual framework and application platforms for atypical antipsychotics.
2004 Feb
Gateways to clinical trials.
2004 Jan-Feb
The case for atypical antipsychotics in bipolar disorder.
2004 Jan-Mar
Gateways to clinical trials.
2004 Mar
International Congress of Biological Psychiatry. 8-13 February 2004, Sydney, Australia.
2004 Mar
Patents

Sample Use Guides

In adults with schizophrenia the recommended starting and target dose for aripiprazole (ABILIFY) is 10 or 15 mg/day. In adolescents the target dose is 10 mg/day. In adults with Bipolar I Disorder, the recommended starting dose is 15 mg given once daily as monotherapy and 10 mg to 15 mg given once daily as adjunctive therapy with lithium or valproate. In pediatric patients (10 to 17 years) with Bipolar I Disorder, the starting dose as monotherapy is 2 mg/day, with titration to 5 mg/day after 2 days, and a target dose of 10 mg/day after 2 additional days. In adults with Major Depressive Disorder, the recommended starting dose as adjunctive treatment for patients already taking an antidepressant is 2 to 5 mg/day. The recommended dosage range is 2 to 15 mg/day. In pediatric patients with Irritability Associated with Autistic Disorder, dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 or 15 mg/day if needed. In pediatric patient with Tourette’s Disorder, the recommended dosage is 5 to 20 mg/day. In adults with Agitation Associated with Schizophrenia or Bipolar Mania, the recommended dose is 9.75 mg. The recommended dosage range is 5.25 to 15 mg.
Route of Administration: Other
PC12 cells were treated with 0.001-1.0 uM aripiprazole in the presence of NGF (2.5ng/ml). Aripiprazole significantly potentiated nerve growth factor (NGF)-induced neurite outgrowth in PC12 cells, in a concentration-dependent manner.
Substance Class Chemical
Created
by admin
on Mon Mar 31 21:26:16 GMT 2025
Edited
by admin
on Mon Mar 31 21:26:16 GMT 2025
Record UNII
82VFR53I78
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
ARIPIPRAZOLE
EMA EPAR   HSDB   INN   JAN   MART.   MI   ORANGE BOOK   USAN   USP-RS   VANDF   WHO-DD  
INN   USAN  
Official Name English
ABILIFY
Preferred Name English
ARIPIPRAZOLE [USAN]
Common Name English
ARIPIPRAZOLE [USP MONOGRAPH]
Common Name English
ABILIFY MYCITE
Brand Name English
ABILIFY MAINTENA
Brand Name English
OPC-14597
Code English
ARIPIPRAZOLE [MART.]
Common Name English
ARIPIPRAZOLE [HSDB]
Common Name English
OPC-31
Code English
aripiprazole [INN]
Common Name English
2(1H)-QUINOLINONE, 7-(4-(4-(2,3-DICHLOROPHENYL)-1-PIPERAZINYL)BUTOXY)-3,4-DIHYDRO-
Systematic Name English
ARIPIPREX
Brand Name English
7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril
Common Name English
NSC-759266
Code English
Aripiprazole [WHO-DD]
Common Name English
ARIPIPRAZOLE [MI]
Common Name English
ARIPIPRAZOLE [VANDF]
Common Name English
ARIPIPRAZOLE [JAN]
Common Name English
ARIPIPRAZOLE [EMA EPAR]
Common Name English
ARIPIPRAZOLE [USP-RS]
Common Name English
ARIPIPRAZOLE [EP MONOGRAPH]
Common Name English
ARIPIPRAZOLE [ORANGE BOOK]
Common Name English
ABILIFY MYCITE KIT
Brand Name English
Classification Tree Code System Code
NCI_THESAURUS C29710
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
FDA ORPHAN DRUG 207905
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
EMA ASSESSMENT REPORTS ABILIFY (AUTHORIZED: BIPOLAR DISORDER)
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
LIVERTOX NBK547858
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
EMA ASSESSMENT REPORTS ABILIFY MAINTENA (AUTHORIZED: SCHIZOPHRENIA)
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
WHO-ATC N05AX12
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
FDA ORPHAN DRUG 694219
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
EMA ASSESSMENT REPORTS ABILIFY (AUTHORIZED: SCHIZOPHRENIA)
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
WHO-VATC QN05AX12
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
NDF-RT N0000175430
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
Code System Code Type Description
HSDB
7320
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
WIKIPEDIA
ARIPIPRAZOLE
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
LACTMED
Aripiprazole
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
DAILYMED
82VFR53I78
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
MERCK INDEX
m2046
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY Merck Index
CHEBI
31236
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
INN
7477
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
PUBCHEM
60795
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
EPA CompTox
DTXSID3046083
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
NCI_THESAURUS
C47403
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
DRUG BANK
DB01238
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
NSC
759266
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
IUPHAR
34
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
ChEMBL
CHEMBL1112
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
EVMPD
SUB05564MIG
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
DRUG CENTRAL
242
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
RS_ITEM_NUM
1042634
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
MESH
C094645
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
FDA UNII
82VFR53I78
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
USAN
II-87
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
RXCUI
89013
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY RxNorm
CAS
129722-12-9
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
SMS_ID
100000089957
Created by admin on Mon Mar 31 21:26:16 GMT 2025 , Edited by admin on Mon Mar 31 21:26:16 GMT 2025
PRIMARY
Related Record Type Details
TARGET->PARTIAL AGONIST
Ki
TARGET->PARTIAL AGONIST
Ki
BINDER->LIGAND
BINDING
EXCRETED UNCHANGED
FECAL
TARGET->PARTIAL AGONIST
Ki
TARGET->PARTIAL AGONIST
Emax = 68.1% of effect of 1 micromolar of 5-HT.
EC50
METABOLIC ENZYME -> SUBSTRATE
TARGET -> INHIBITOR
Ki
EXCRETED UNCHANGED
URINE
TARGET -> INHIBITOR
TARGET->LIGAND
Ki
TARGET->INVERSE AGONIST
Ki
TARGET->PARTIAL AGONIST
Primary target for antipsychotic activity. The partial agonist actions of aripiprazole vary widely depending upon the cellular milieu. Thus, nearly fullagonism, weak partial agonism and frank antagonism, have all been reported, depending upon the assay system and cellular background.
Ki
TARGET -> INHIBITOR
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METABOLIC ENZYME -> SUBSTRATE
TARGET -> INHIBITOR
SOLVATE->ANHYDROUS
SALT/SOLVATE -> PARENT
TARGET -> INHIBITOR
Ki
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METABOLITE -> PARENT
URINE
METABOLITE -> PARENT
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METABOLITE ACTIVE -> PARENT
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N-Dealkylation metabolite thru CYP3A4 exposure.
METABOLITE -> PARENT
METABOLITE -> PARENT
METABOLITE -> PARENT
METABOLITE -> PARENT
FECAL
METABOLITE -> PARENT
PLASMA
METABOLITE -> PARENT
URINE
METABOLITE -> PARENT
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METABOLITE -> PARENT
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METABOLITE -> PARENT
PLASMA
METABOLITE ACTIVE -> PARENT
MAJOR
FECAL
METABOLITE -> PARENT
URINE
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IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
IMPURITY -> PARENT
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
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CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
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ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Biological Half-life PHARMACOKINETIC
ORAL BIOAVAILABILITY PHARMACOKINETIC
Volume of Distribution PHARMACOKINETIC
Tmax PHARMACOKINETIC