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
SMILES
ClC1=CC=CC(N2CCN(CCCCOC3=CC=C4CCC(=O)NC4=C3)CC2)=C1Cl
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)
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 |
DescriptionSources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdfCurator'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/
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf
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.
CNS Activity
Originator
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL217 |
0.34 nM [Ki] | ||
Target ID: CHEMBL224 |
8.7 nM [Ki] | ||
Target ID: CHEMBL214 |
5.6 nM [Ki] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | ABILIFY Approved UseABILIFY 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 Date2002 |
|||
Primary | ABILIFY Approved UseABILIFY 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 Date2002 |
|||
Primary | ABILIFY Approved UseABILIFY 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 Date2002 |
|||
Primary | ABILIFY Approved UseABILIFY 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 Date2002 |
|||
Primary | ABILIFY Approved UseABILIFY 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 Date2002 |
|||
Primary | ABILIFY Approved UseABILIFY 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 Date2002 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
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
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
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
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
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
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
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
Dose | Population | Adverse 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 n = 6 Health Status: unhealthy Condition: Psychiatric Disorders Age Group: 10-17 years Sex: M+F Population Size: 6 Sources: |
Other AEs: Abdominal pain upper, Vomiting... Other AEs: Abdominal pain upper (17%) Sources: Vomiting (17%) Dizziness (17%) Headache (50%) Sedation (33%) Somnolence (17%) |
2 mg single, intravenous Dose: 2 mg Route: intravenous Route: single Dose: 2 mg Sources: |
healthy, 35 years (range: 18-45 years) n = 16 Health Status: healthy Age Group: 35 years (range: 18-45 years) Sex: M+F Population Size: 16 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) n = 4 Health Status: unhealthy Condition: schizophrenia Age Group: 39 years (range: 18-65 years) Sex: M+F Population Size: 4 Sources: |
|
195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
Other AEs: Vomiting, Somnolence... Other AEs: Vomiting Sources: 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 |
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 n = 100 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 100 Sources: |
Other AEs: Extrapyramidal disorder, Neuroleptic malignant syndrome... Other AEs: Extrapyramidal disorder (serious, 1 patient) Sources: 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) |
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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 Sources: |
Other AEs: Varicella, Depression... Other AEs: Varicella (serious, 1 patient) Sources: 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) |
1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
Other AEs: Vomiting, Somnolence... Other AEs: Vomiting Sources: 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 |
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 Condition: Dementia-Related Psychosis Age Group: adult Sources: |
Other AEs: Adverse event... Other AEs: Adverse event (grade 5) Sources: |
15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Other AEs: Constipation, Diarrhea... Other AEs: Constipation (below serious, 8 patients) Sources: 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) |
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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 Sources: |
Other AEs: Abdominal pain, Bruising... Other AEs: Abdominal pain (below serious, 7 patients) Sources: 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) |
20 mg 1 times / day steady, oral (max) Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 7 Health Status: unhealthy Condition: posttraumatic stress disorder Population Size: 7 Sources: |
Other AEs: Restlessness, Decreased activity... Other AEs: Restlessness (below serious, 2 patients) Sources: 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) |
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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 Sources: |
Other AEs: Rhabdomyolysis, Pneumonia... Other AEs: Rhabdomyolysis (serious, 1 patient) Sources: 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) |
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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 Sources: |
Other AEs: Suicidal ideation, Gun shot wound... Other AEs: Suicidal ideation (serious, 2 patients) Sources: 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) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
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 n = 6 Health Status: unhealthy Condition: Psychiatric Disorders Age Group: 10-17 years Sex: M+F Population Size: 6 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 n = 6 Health Status: unhealthy Condition: Psychiatric Disorders Age Group: 10-17 years Sex: M+F Population Size: 6 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 n = 6 Health Status: unhealthy Condition: Psychiatric Disorders Age Group: 10-17 years Sex: M+F Population Size: 6 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 n = 6 Health Status: unhealthy Condition: Psychiatric Disorders Age Group: 10-17 years Sex: M+F Population Size: 6 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 n = 6 Health Status: unhealthy Condition: Psychiatric Disorders Age Group: 10-17 years Sex: M+F Population Size: 6 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 n = 6 Health Status: unhealthy Condition: Psychiatric Disorders Age Group: 10-17 years Sex: M+F Population Size: 6 Sources: |
Acidosis | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Aggression | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Aspartate aminotransferase increased | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Aspiration pneumonia | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Atrial fibrillation | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Blood creatine phosphokinase increased | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Coma | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Confusional state | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Convulsion | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Depressed level of consciousness | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Hypertension | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Hypokalemia | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Hypotension | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Lethargy | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Loss of consciousness | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
QT prolonged | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Respiratory arrest | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Somnolence | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Status epilepticus | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Tachycardia | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Tremor | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 Sources: |
|
Vomiting | 195 mg single, oral Overdose Dose: 195 mg Route: oral Route: single Dose: 195 mg Sources: |
unhealthy, < 12 years n = 10 Health Status: unhealthy Age Group: < 12 years Population Size: 10 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 n = 100 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 100 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 n = 100 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 100 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 n = 100 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 100 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 n = 100 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 100 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 n = 100 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 100 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 n = 100 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 100 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 n = 100 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 100 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 n = 100 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 100 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 n = 100 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 100 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 n = 100 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 100 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 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 n = 102 Health Status: unhealthy Condition: schizophrenia Age Group: adolescent Population Size: 102 Sources: |
Acidosis | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Aggression | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Aspartate aminotransferase increased | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Aspiration pneumonia | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Atrial fibrillation | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Blood creatine phosphokinase increased | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Coma | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Confusional state | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Convulsion | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Depressed level of consciousness | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Hypertension | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Hypokalemia | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Hypotension | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Lethargy | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Loss of consciousness | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
QT prolonged | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Respiratory arrest | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Somnolence | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Status epilepticus | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Tachycardia | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Tremor | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 Sources: |
|
Vomiting | 1080 mg single, oral Overdose Dose: 1080 mg Route: oral Route: single Dose: 1080 mg Sources: |
unhealthy, adult n = 1 Health Status: unhealthy Age Group: adult Population Size: 1 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 Condition: Dementia-Related Psychosis Age Group: adult Sources: |
Decreased appetite | below serious, 12 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Vomiting | below serious, 15 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Increased appetite | below serious, 16 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Nausea | below serious, 2 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Tiredness | below serious, 21 patient | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Enuresis | below serious, 3 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Feeling sad | below serious, 3 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Fever | below serious, 3 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Muscle rigidity | below serious, 3 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Nervousness | below serious, 3 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Nose bleed | below serious, 3 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Repetitive speech | below serious, 3 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Restlessness | below serious, 3 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Self injurious behavior | below serious, 3 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Tremor | below serious, 3 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Dizziness | below serious, 4 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Drowsiness | below serious, 5 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Abdominal discomfort | below serious, 7 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Diarrhea | below serious, 7 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Constipation | below serious, 8 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 Sources: |
Weight gain | below serious, 8 patients | 15 mg 1 times / day steady, oral (max) Dose: 15 mg, 1 times / day Route: oral Route: steady Dose: 15 mg, 1 times / day Sources: |
unhealthy, children n = 40 Health Status: unhealthy Condition: autism Age Group: children Population Size: 40 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 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 n = 20 Health Status: unhealthy Condition: schizophrenia Sex: F Population Size: 20 Sources: |
Cold extremities | below serious, 1 patient | 20 mg 1 times / day steady, oral (max) Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 7 Health Status: unhealthy Condition: posttraumatic stress disorder Population Size: 7 Sources: |
Decreased activity | below serious, 1 patient | 20 mg 1 times / day steady, oral (max) Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 7 Health Status: unhealthy Condition: posttraumatic stress disorder Population Size: 7 Sources: |
Joint stiffness | below serious, 1 patient | 20 mg 1 times / day steady, oral (max) Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 7 Health Status: unhealthy Condition: posttraumatic stress disorder Population Size: 7 Sources: |
Vertigo | below serious, 1 patient | 20 mg 1 times / day steady, oral (max) Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 7 Health Status: unhealthy Condition: posttraumatic stress disorder Population Size: 7 Sources: |
Blurred vision | below serious, 2 patients | 20 mg 1 times / day steady, oral (max) Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 7 Health Status: unhealthy Condition: posttraumatic stress disorder Population Size: 7 Sources: |
Drowsiness | below serious, 2 patients | 20 mg 1 times / day steady, oral (max) Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 7 Health Status: unhealthy Condition: posttraumatic stress disorder Population Size: 7 Sources: |
Restlessness | below serious, 2 patients | 20 mg 1 times / day steady, oral (max) Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 7 Health Status: unhealthy Condition: posttraumatic stress disorder Population Size: 7 Sources: |
Sexual disorder NOS | below serious, 2 patients | 20 mg 1 times / day steady, oral (max) Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy n = 7 Health Status: unhealthy Condition: posttraumatic stress disorder Population Size: 7 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 45 Health Status: unhealthy Condition: Methamphetamine Dependence Population Size: 45 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 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 n = 269 Health Status: unhealthy Condition: schizophrenia Population Size: 269 Sources: |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
---|---|---|
Drug as perpetrator
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
Page: 1.0 |
yes | |||
Page: 29.0 |
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 |
||
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
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
PubMed
Title | Date | PubMed |
---|---|---|
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 |
|
Dopamine system stabilizers, aripiprazole, and the next generation of antipsychotics, part 2: illustrating their mechanism of action. | 2001 Dec |
|
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 |
|
Partial dopamine agonists and dopaminergic stabilizers, in the treatment of psychosis. | 2002 Apr |
|
The antipsychotic aripiprazole is a potent, partial agonist at the human 5-HT1A receptor. | 2002 Apr 26 |
|
Dopamine D2 and D3 receptor occupancy in normal humans treated with the antipsychotic drug aripiprazole (OPC 14597): a study using positron emission tomography and [11C]raclopride. | 2002 Aug |
|
Gateways to clinical trials. | 2002 Dec |
|
Aripiprazole: profile on efficacy and safety. | 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 |
|
Gateways to clinical trials. | 2002 Nov |
|
Biological perspectives. Aripiprazole: a third generation of antipsychotics begins? | 2002 Oct-Dec |
|
Choice of maintenance medication for schizophrenia. | 2003 |
|
[The next generation of "atypical" antipsychotics: the role of positron emission tomography]. | 2003 Aug |
|
Medication developments in the treatment of mental illness. | 2003 Dec |
|
Aripiprazole. | 2003 Dec 1 |
|
Aripiprazole. The newest antipsychotic agent for treatment of schizophrenia. | 2003 Feb |
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Aripiprazole (Abilify) for schizophrenia. | 2003 Feb 17 |
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Gateways to clinical trials. | 2003 Jan-Feb |
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New product intros. | 2003 Jan-Feb |
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Aripiprazole in the treatment of schizophrenia: safety and tolerability in short-term, placebo-controlled trials. | 2003 Jun 1 |
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Aripiprazole: a new atypical antipsychotic drug. | 2003 May |
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Serotonin receptors: their key role in drugs to treat schizophrenia. | 2003 Oct |
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Mechanism of new antipsychotic medications: occupancy is not just antagonism. | 2003 Oct |
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Gateways to clinical trials. | 2004 Apr |
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The Texas Medication Algorithm Project antipsychotic algorithm for schizophrenia: 2003 update. | 2004 Apr |
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Drug induced weight gain, an impediment to successful pharmacotherapy: focus on antipsychotics. | 2004 Apr |
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Aripiprazole, a novel atypical antipsychotic drug. | 2004 Feb |
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Atypical antipsychotics: pharmacokinetics, therapeutic drug monitoring and pharmacological interactions. | 2004 Feb |
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Schizophrenia: from dopamine to glutamate and back. | 2004 Feb |
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Aripiprazole possibly worsens psychosis. | 2004 Jan |
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Worsened agitation with aripiprazole: adverse effect of dopamine partial agonism? | 2004 Jan |
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
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/23047241
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
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on
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Record UNII |
82VFR53I78
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Validated (UNII)
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Classification Tree | Code System | Code | ||
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NCI_THESAURUS |
C29710
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FDA ORPHAN DRUG |
207905
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EMA ASSESSMENT REPORTS |
ABILIFY (AUTHORIZED: BIPOLAR DISORDER)
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LIVERTOX |
NBK547858
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EMA ASSESSMENT REPORTS |
ABILIFY MAINTENA (AUTHORIZED: SCHIZOPHRENIA)
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WHO-ATC |
N05AX12
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FDA ORPHAN DRUG |
694219
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EMA ASSESSMENT REPORTS |
ABILIFY (AUTHORIZED: SCHIZOPHRENIA)
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WHO-VATC |
QN05AX12
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NDF-RT |
N0000175430
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ARIPIPRAZOLE
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Aripiprazole
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m2046
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Related Record | Type | Details | ||
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TARGET->PARTIAL AGONIST |
Ki
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TARGET->PARTIAL AGONIST |
Ki
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BINDER->LIGAND |
BINDING
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EXCRETED UNCHANGED |
FECAL
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TARGET->PARTIAL AGONIST |
Ki
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TARGET->PARTIAL AGONIST |
Emax = 68.1% of effect of 1 micromolar of 5-HT.
EC50
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METABOLIC ENZYME -> SUBSTRATE |
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TARGET -> INHIBITOR |
Ki
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EXCRETED UNCHANGED |
URINE
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TARGET -> INHIBITOR |
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TARGET->LIGAND |
Ki
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TARGET->INVERSE AGONIST |
Ki
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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
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TARGET -> INHIBITOR |
Ki
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METABOLIC ENZYME -> SUBSTRATE |
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TARGET -> INHIBITOR |
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SOLVATE->ANHYDROUS |
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TARGET -> INHIBITOR |
Ki
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METABOLITE -> PARENT |
URINE
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METABOLITE -> PARENT |
URINE
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METABOLITE ACTIVE -> PARENT |
MAJOR
PLASMA
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METABOLITE -> PARENT |
URINE
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METABOLITE -> PARENT |
N-Dealkylation metabolite thru CYP3A4 exposure.
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METABOLITE -> PARENT |
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METABOLITE -> PARENT |
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METABOLITE -> PARENT |
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METABOLITE -> PARENT |
FECAL
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METABOLITE -> PARENT |
PLASMA
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METABOLITE -> PARENT |
URINE
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METABOLITE -> PARENT |
PLASMA
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METABOLITE -> PARENT |
N-Dealkylation metabolite thru CYP3A4 exposure
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METABOLITE -> PARENT |
PLASMA
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METABOLITE ACTIVE -> PARENT |
MAJOR
FECAL
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METABOLITE -> PARENT |
URINE
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Related Record | Type | Details | ||
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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IMPURITY -> PARENT |
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IMPURITY -> PARENT |
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
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IMPURITY -> PARENT |
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
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IMPURITY -> PARENT |
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
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IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
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IMPURITY -> PARENT |
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Related Record | Type | Details | ||
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ACTIVE MOIETY |
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Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
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Biological Half-life | PHARMACOKINETIC |
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ORAL BIOAVAILABILITY | PHARMACOKINETIC |
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Volume of Distribution | PHARMACOKINETIC |
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Tmax | PHARMACOKINETIC |
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