Atypical antipsychotic – dopamine partial agonist
Updated · Methodology
First line
First-line for acute mania and maintenance therapy of bipolar I disorder per CANMAT 2018. Dose 15–30 mg once daily. Effective in preventing manic episodes; inferior to lamotrigine for preventing depressive episodes.
Sources
ICD-10: F31 · ICD-11: 6A60
First line
First-line for schizophrenia and schizoaffective disorder per 2020 and NG178 (2020). Starting dose 10–15 mg once daily, titrated to 15–30 mg. Long-acting injectable (Abilify Maintena 400 mg every 4 weeks) for patients with adherence issues. The Huhn 2019 network meta-analysis showed efficacy comparable to other atypical antipsychotics with better metabolic profile.
Sources
ICD-10: F20 · ICD-11: 6A20
Adjunct
Used as antidepressant augmentation in inadequate response to SSRIs or SNRIs (treatment-resistant depression). Dose 2–5 mg daily. Efficacy shown in several RCTs (CN138-139, CN138-141). Not used as monotherapy for major depressive disorder.
Sources
ICD-10: F32.9 · ICD-11: 6A70.Z
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Aripiprazole is an antipsychotic. It is prescribed for schizophrenia, bipolar disorder, as an add-on to antidepressants for treatment-resistant depression, and for autism spectrum disorder in children ( 2020 and NG178 guidelines). For acute stress or anxiety, aripiprazole has no proven efficacy: no clinical studies of such use exist. The drug has serious side effects: akathisia (a distressing sensation of inner restlessness), metabolic syndrome, pathological gambling and other compulsive behaviors ( warning, 2016). If aripiprazole was prescribed for these indications, consider seeking a second opinion.
ICD-10: F41.9 · ICD-11: 6B0Z
A partial agonist at dopamine D2 and serotonin 5-HT1A receptors and 5-HT2A antagonist. Unlike classical D2 antagonists (haloperidol, risperidone), it acts as a dopamine stabilizer: reducing transmission with hyperactivity (psychosis) and increasing it with hypoactivity (motivational deficit). Compared with other atypical antipsychotics, less weight gain, metabolic disturbance, and prolactinemia. CYP3A4- and CYP2D6-metabolized, half-life 75 hours.
Boxed warning
FDA boxed warning: increased mortality in elderly patients with dementia treated with atypical antipsychotics. Aripiprazole is not approved for dementia-related psychosis.
Limited pregnancy data. T3 use carries neonatal extrapyramidal and withdrawal risk. In pregnant psychotic patients, decisions are made with the psychiatrist.
Milk concentrations are low. Use during lactation is possible when needed, with monitoring of infant sedation and weight gain.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
1 pair found. Sorted from critical to minor.
Mechanism
Ritonavir inhibits CYP3A4 (and weakly CYP2D6). Aripiprazole rises 2-3 fold. Enhanced extrapyramidal effects and sedation.
Symptoms
Sedation, akathisia, dyskinesia.
Management
Halve aripiprazole dose.
Verbatim lines from the interaction sections, in the language of the label
«Drugs Having Clinically Important Interactions with Aripiprazole: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine)…»FDA, section 7 · Open on DailyMed
«Drugs Having Clinically Important Interactions with Aripiprazole: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine)…»FDA, section 7 · Open on DailyMed
«Drugs Having Clinically Important Interactions with Aripiprazole: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine)…»FDA, section 7 · Open on DailyMed
«Drugs Having Clinically Important Interactions with Aripiprazole: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine)…»FDA, section 7 · Open on DailyMed
«Drugs Having Clinically Important Interactions with Aripiprazole: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine)…»FDA, section 7 · Open on DailyMed
«Drugs Having Clinically Important Interactions with Aripiprazole: Benzodiazepines (e.g., lorazepam) The intensity of sedation was greater with the combination of oral aripiprazole and lorazepam as…»FDA, section 7 · Open on DailyMed
«Drugs Having Clinically Important Interactions with Aripiprazole: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine)…»FDA, section 7 · Open on DailyMed
«Drugs Having Clinically Important Interactions with Aripiprazole: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine)…»FDA, section 7 · Open on DailyMed
«Drugs Having Clinically Important Interactions with Aripiprazole: Benzodiazepines (e.g., lorazepam) The intensity of sedation was greater with the combination of oral aripiprazole and lorazepam as…»FDA, section 7 · Open on DailyMed
«Interacción de otros medicamentos con aripiprazol: Carbamazepina y otros inductores de CYP3A4»AEMPS, section 4.5 · Open on CIMA
«Drugs Having Clinically Important Interactions with Aripiprazole: Strong CYP3A4 Inducers (e.g., carbamazepine, rifampin) Concomitant use of aripiprazole and carbamazepine decreased the exposure of…»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: Strong CYP3A4 inducers Double usual dose over 1 to 2 weeks»FDA, section 7 · Open on DailyMed
«Interacción de aripiprazol con otros medicamentos: En ensayos clínicos, dosis de aripiprazol de 10-30 mg/AEMPS, section 4.5 · Open on CIMA
«Drugs Having No Clinically Important Interactions with Aripiprazole: In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or…»FDA, section 7 · Open on DailyMed
«Interacción de otros medicamentos con aripiprazol: Se pueden esperar pequeños aumentos de las concentraciones plasmáticas de aripiprazol cuando se utiliza de forma concomitante con inhibidores…»AEMPS, section 4.5 · Open on CIMA
«Interacción de otros medicamentos con aripiprazol: La dosis de aripiprazol debe ser duplicada cuando se administra conjuntamente con carbamazepina. Cabe esperar que la administración concomitante de…»AEMPS, section 4.5 · Open on CIMA
«Interacción de otros medicamentos con aripiprazol: Se pueden esperar pequeños aumentos de las concentraciones plasmáticas de aripiprazol cuando se utiliza de forma concomitante con inhibidores…»AEMPS, section 4.5 · Open on CIMA
«Drugs Having No Clinically Important Interactions with Aripiprazole: In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or…»FDA, section 7 · Open on DailyMed
«Interacción de otros medicamentos con aripiprazol: Famotidina, antagonista H2, bloqueante de los ácidos gástricos, reduce la tasa de absorción de aripiprazol, pero se considera que este efecto no es…»AEMPS, section 4.5 · Open on CIMA
«Drugs Having No Clinically Important Interactions with Aripiprazole: Based on pharmacokinetic studies, no dosage adjustment of aripiprazole is required when administered concomitantly with…»FDA, section 7 · Open on DailyMed
«Interacción de otros medicamentos con aripiprazol: En un ensayo clínico en sujetos sanos, un inhibidor potente del CYP2D6 (quinidina) aumentó el AUC de aripiprazol en 107 %, mientras que la C max no…»AEMPS, section 4.5 · Open on CIMA
«Interacción de otros medicamentos con aripiprazol: Carbamazepina y otros inductores de CYP3A4»AEMPS, section 4.5 · Open on CIMA
«Interacción de otros medicamentos con aripiprazol: Quinidina y otros inhibidores de CYP2D6»AEMPS, section 4.5 · Open on CIMA
«Interacción de otros medicamentos con aripiprazol: Ketoconazol y otros inhibidores de CYP3A4»AEMPS, section 4.5 · Open on CIMA
«Interacción de otros medicamentos con aripiprazol: Se han notificado casos de síndrome serotoninérgico en pacientes en tratamiento con aripiprazol, especialmente en casos de tratamiento concomitante…»AEMPS, section 4.5 · Open on CIMA
«Interacción de otros medicamentos con aripiprazol: En un ensayo clínico en sujetos sanos, un inhibidor potente de CYP3A4 (ketoconazol) aumentó el AUC y la C max de aripiprazol en 63 % y 37 %…»AEMPS, section 4.5 · Open on CIMA
«Interacción de otros medicamentos con aripiprazol: Ketoconazol y otros inhibidores de CYP3A4»AEMPS, section 4.5 · Open on CIMA
«Interacción de aripiprazol con otros medicamentos: Cuando se administra aripiprazol conjuntamente con valproato, litio o lamotrigina, no se han encontrado cambios clínicamente significativos en las…»AEMPS, section 4.5 · Open on CIMA
«Drugs Having No Clinically Important Interactions with Aripiprazole: In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or…»FDA, section 7 · Open on DailyMed
«Drugs Having No Clinically Important Interactions with Aripiprazole: Based on pharmacokinetic studies, no dosage adjustment of aripiprazole is required when administered concomitantly with…»FDA, section 7 · Open on DailyMed
«Interacción de otros medicamentos con aripiprazol: Síndrome serotoninérgico»AEMPS, section 4.5 · Open on CIMA
«Interacción de aripiprazol con otros medicamentos: En ensayos clínicos, dosis de aripiprazol de 10-30 mg/AEMPS, section 4.5 · Open on CIMA
«Drugs Having No Clinically Important Interactions with Aripiprazole: In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or…»FDA, section 7 · Open on DailyMed
«Interacción de otros medicamentos con aripiprazol: En un ensayo clínico en sujetos sanos, un inhibidor potente del CYP2D6 (quinidina) aumentó el AUC de aripiprazol en 107 %, mientras que la C max no…»AEMPS, section 4.5 · Open on CIMA
«Interacción de otros medicamentos con aripiprazol: La dosis de aripiprazol debe ser duplicada cuando se administra conjuntamente con carbamazepina. Cabe esperar que la administración concomitante de…»AEMPS, section 4.5 · Open on CIMA
«Interacción de otros medicamentos con aripiprazol: La dosis de aripiprazol debe ser duplicada cuando se administra conjuntamente con carbamazepina. Cabe esperar que la administración concomitante de…»AEMPS, section 4.5 · Open on CIMA
«Sustratos de CYP2D6: antipsicóticos (aripiprazol, haloperidol, risperidona, tioridazina),»AEMPS, section 4.5 · Open on CIMA
«Fármacos que pueden disminuir los niveles plasmáticos de carbamazepina: Antipsicóticos: clozapina, haloperidol y bromperidol, olanzapina, quetiapina, risperidona, ziprasidona, aripiprazol…»AEMPS, section 4.5 · Open on CIMA
«Medicamentos reguladores de lípidos: Aripiprazol 3 mg»AEMPS, section 4.5 · Open on CIMA
«Fármacos que tienen poco o ningún efecto en la concentración de lamotrigina: Aripiprazol»AEMPS, section 4.5 · Open on CIMA
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Aripiprazole is evaluated for the following indications with varying evidence strength: Bipolar disorder maintenance (evidence tier A), Schizophrenia (evidence tier A), Major depressive disorder (evidence tier B). See the full indication matrix with dosing and citations above on this page.
Common side effects of Aripiprazole (≥ 1 in 100): Insomnia, Anxiety and akathisia, Headache, Nausea, Constipation, Drowsiness. See the Safety section for uncommon and serious reactions.
Limited pregnancy data. T3 use carries neonatal extrapyramidal and withdrawal risk. In pregnant psychotic patients, decisions are made with the psychiatrist.
Milk concentrations are low. Use during lactation is possible when needed, with monitoring of infant sedation and weight gain.
Aripiprazole is contraindicated in: Aripiprazole hypersensitivity; Pregnancy (except life-saving indications); Lactation; Age under 13 (schizophrenia), under 10 (bipolar) – per EMA. Full list in the Safety section.
FDA boxed warning: increased mortality in elderly patients with dementia treated with atypical antipsychotics. Aripiprazole is not approved for dementia-related psychosis.
Direct links to regulator labels. Open in a new tab.
Bromazepam, Chamomile (Matricaria chamomilla / recutita, flowers), Chlorpromazine, Clobazam, Diazepam, Lithium, Phenazepam, Selank (Thr-Lys-Pro-Arg-Pro-Gly-Pro)