Aripiprazole

Pronunciation: ar-i-PIP-ra-zole.

Generic name
aripiprazole
Drug class
Atypical antipsychotic (dopamine D2 and serotonin 5-HT1A receptor partial agonist; serotonin 5-HT2A receptor antagonist)
Form
Tablet (2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg); oral solution; solution for injection; long-acting injectable suspension
Route
Oral; intramuscular injection (acute agitation); long-acting intramuscular injection (maintenance)
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Abilify (4), Abilify Maintena / Abilify Asimtufii (4) · Full directory

What aripiprazole is and how it works

Aripiprazole is a prescription-only atypical antipsychotic medicine used to treat schizophrenia and bipolar I disorder. In the United States and Canada it is also used as an add-on treatment for depression that has not responded adequately to an antidepressant alone, and (US only) for irritability associated with autistic disorder and for Tourette's disorder in children. (1)

Aripiprazole carries two real boxed warnings -- the FDA's strongest safety warnings. The first concerns an increased risk of death in elderly people with dementia-related psychosis; aripiprazole is not approved for that use. The second concerns an increased risk of suicidal thoughts and behaviour in children, adolescents, and young adults taking antidepressants, which is directly relevant if aripiprazole is being added to your antidepressant treatment. Your prescriber will discuss both risks with you and monitor you closely, especially early in treatment.

Mechanism of action: how aripiprazole works

Aripiprazole's mechanism of action is thought to be mediated through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors, and antagonist activity at serotonin 5-HT2A receptors, distinguishing it from most other antipsychotics that act primarily as dopamine antagonists. (1) (3)

What aripiprazole is used for

Schizophrenia

Approved for the treatment of schizophrenia in adults and adolescents (age ranges vary slightly by country: 13-17 in the US, 15-17 in the UK/EU). (1) (2) (3)

Bipolar I disorder (manic or mixed episodes)

Approved for acute treatment of manic or mixed episodes in bipolar I disorder, as monotherapy or added to lithium/divalproex, in adults and (in some markets) adolescents. Also approved in the UK/EU for prevention of manic episode recurrence. (1) (2) (3)

Add-on treatment for major depressive disorder (United States and Canada only)

Approved in the US and Canada as an add-on to an antidepressant in adults whose depression has not responded adequately to the antidepressant alone. This is NOT an approved use in the UK or EU. Health Canada specifically notes this should be used for the shortest clinically indicated period, by clinicians experienced in managing antipsychotic-class safety concerns, since its safety and efficacy in this use have not been systematically evaluated beyond 6 weeks. (1) (3)

Irritability associated with autistic disorder (United States only)

Approved in the US for irritability associated with autistic disorder in children and adolescents aged 6-17. Not an approved UK/EU indication. (1)

Tourette's disorder (United States only)

Approved in the US for Tourette's disorder in children and adolescents aged 6-18. Not an approved UK/EU indication. (1)

Before taking aripiprazole

Do not take / not appropriate for

  • Do not take aripiprazole if you have had an allergic reaction to it or any of its ingredients (reactions have ranged from hives to anaphylaxis). (all confirmed markets) (1) (3)
  • Aripiprazole is not approved for treating psychosis related to dementia, and is not indicated in elderly patients with dementia. (United States, Canada) (1) (3)

Tell your clinician about

  • If aripiprazole is being added to an antidepressant for depression, whether you (or the person being treated) are a child, adolescent, or young adult -- this combination carries a real risk of increased suicidal thinking and behaviour that needs close monitoring.
  • Any personal or family history of an irregular heartbeat, or other heart or blood vessel disease, especially if aripiprazole is being considered for an elderly person with dementia-related symptoms.
  • Any history of diabetes, high blood sugar, or high cholesterol -- aripiprazole can affect blood sugar and lipid levels.
  • Any personal or family history of movement disorders.
  • Any history of seizures.
  • Any history of gambling problems, compulsive shopping, binge eating, or hypersexual behaviour, or if any of these develop during treatment.
  • All other medicines you take, especially strong CYP2D6 or CYP3A4 inhibitors or inducers.
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1) (2) (3)

How to take aripiprazole

  • Take aripiprazole exactly as your prescriber directs, once daily, with or without food.
  • Do not change your dose or stop taking aripiprazole without talking to your prescriber first.
  • If you also take a strong inhibitor or inducer of certain liver enzymes (CYP2D6 or CYP3A4), your prescriber will adjust your dose accordingly.
  • Attend all follow-up appointments so your prescriber can monitor for movement changes, blood sugar/cholesterol changes, and mood or behaviour changes.
(1) (3)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, take it as soon as you remember unless it is almost time for your next dose -- in that case, skip the missed dose and continue your regular schedule. Do not take a double dose. Contact your prescriber if you are unsure.

Overdose

Seek urgent medical attention if too much aripiprazole may have been taken, or if you develop severe drowsiness, an irregular heartbeat, fainting, or seizures. (3)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Nausea, vomiting, constipation -- common in adults.

What to notice: Nausea, vomiting, constipation -- common in adults.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache, dizziness -- common in adults.

What to notice: Headache, dizziness -- common in adults.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Akathisia (an inner restlessness or urge to move), anxiety, insomnia, restlessness -- common in adults.

What to notice: Akathisia (an inner restlessness or urge to move), anxiety, insomnia, restlessness -- common in adults.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Somnolence (sleepiness), increased appetite, extrapyramidal disorder (movement-related side effects), fatigue -- more common in children and adolescents (somnolence in about 24% of pediatric patients vs 11% of adults).

What to notice: Somnolence (sleepiness), increased appetite, extrapyramidal disorder (movement-related side effects), fatigue -- more common in children and adolescents (somnolence in about 24% of pediatric patients vs 11% of adults).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Increased risk of death in elderly patients with dementia-related psychosis — boxed_warning

Symptoms: This is a population-level risk identified in clinical trials of antipsychotic medicines as a class, not a specific symptom to watch for.

Action: Aripiprazole is not approved for treating dementia-related psychosis. In a Health Canada analysis of 13 placebo-controlled trials of atypical antipsychotics in elderly dementia patients (modal duration 10 weeks), there was a mean 1.6-fold increase in the death rate compared with placebo, with most deaths cardiovascular (e.g. heart failure, sudden death) or infectious (e.g. pneumonia) in nature. Discuss the risks and benefits carefully with the prescriber if this medicine is being considered for an older adult. (1) (3)

Increased risk of suicidal thoughts and behaviour in children, adolescents, and young adults taking antidepressants — boxed_warning

Symptoms: New or worsening depression, anxiety, agitation, irritability, hostility, aggressiveness, impulsivity, or thoughts of self-harm or suicide.

Action: If aripiprazole is being added to an antidepressant, monitor closely for these signs, particularly early in treatment or after any dose change, and contact a prescriber or emergency services immediately if they occur. (1)

Signs of tardive dyskinesia — high caution

Symptoms: Uncontrollable, repetitive body movements (such as grimacing, tongue movements, or lip smacking).

Action: Tell your prescriber promptly -- this may be irreversible in some cases. Your prescriber aims to use the lowest effective dose for the shortest duration to reduce this risk. (1)

Signs of neuroleptic malignant syndrome — emergency

Symptoms: High fever, severe muscle stiffness, confusion, rapid or irregular heartbeat, sweating.

Action: Seek emergency medical attention immediately. All antipsychotic medicines, and any other non-essential medicines, need to be stopped right away, and intensive monitoring and treatment are required. (1)

New or worsening impulse-control problems — moderate caution

Symptoms: Intense urges to gamble, shop compulsively, binge eat, or engage in compulsive sexual behaviour.

Action: Tell your prescriber if you notice any of these urges developing or worsening -- dose reduction or stopping aripiprazole may be considered. (1) (2)

Signs of high blood sugar or metabolic changes — moderate caution

Symptoms: Increased thirst, frequent urination, unexplained weight gain, fatigue.

Action: Your prescriber will monitor blood sugar, cholesterol, and weight during treatment, particularly in adolescents. (1) (2)

Cerebrovascular events (stroke, TIA) in elderly patients with dementia-related psychosis — high caution

Symptoms: Sudden weakness, difficulty speaking, confusion, or vision changes.

Action: Seek emergency medical attention immediately. This risk showed a statistically significant dose-response relationship in clinical trials, reinforcing why aripiprazole is not approved for dementia-related psychosis. (1)

Interactions

  • Strong CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) or strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, certain HIV protease inhibitors): reduce aripiprazole dose to about half; if both types are combined, reduce to about a quarter. (1) (2)
  • Strong CYP3A4 inducers (e.g. carbamazepine, rifampicin, phenytoin, St John's Wort): aripiprazole dose approximately doubled over 1-2 weeks. (1) (2)
  • Other antidepressants, when aripiprazole is used adjunctively for depression: increases the class-wide antidepressant risk of suicidal thinking in children, adolescents, and young adults -- requires close monitoring. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Third-trimester exposure to antipsychotics including aripiprazole may cause extrapyramidal symptoms and/or withdrawal symptoms in newborns. Should not be used in pregnancy unless the expected benefit clearly outweighs the potential risk to the fetus. (1) (2) (3) (4) (5) (6)

Breastfeeding

A decision must be made whether to discontinue breastfeeding or discontinue aripiprazole, taking into account the benefit of breastfeeding and the importance of the therapy to the mother. (1) (2) (3) (4) (5) (6)

Children

Approved uses in children/adolescents vary by market and indication (schizophrenia, bipolar mania, autism-related irritability, Tourette's disorder in the US; schizophrenia and bipolar mania from age 13-15+ in the UK/EU). Adjunctive MDD treatment is not established and not recommended in patients under 18. Children and adolescents may be more sensitive to certain side effects (weight gain, hyperlipidemia, hyperglycemia, extrapyramidal effects) than adults. (1) (2) (3) (4) (5) (6)

Elderly

Aripiprazole is not indicated in elderly patients with dementia because of the boxed-warning mortality risk. Safety and efficacy in patients 65 and older for other indications has not been established; a lower starting dose may be considered given greater sensitivity in this population where clinical factors warrant. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

No dosage adjustment is required for patients with hepatic impairment. (1) (2) (3) (4) (5) (6)

Renal_impairment

No dosage adjustment is required for patients with renal impairment. (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-ABILIFY-2026,UK-EMC-ABILIFY-15MG-2026,CA-HEALTHCANADA-ARIPIPRAZOLE-2026 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Baseline weight, blood sugar, and cholesterol
  • Review of personal/family history of movement disorders, seizures, or cardiovascular disease
  • Review of all other medicines for CYP2D6/CYP3A4 interactions
  • For adjunctive depression use: assessment of suicide risk, especially in children/adolescents/young adults

During treatment

  • Monitoring for movement changes (possible tardive dyskinesia).
  • Monitoring blood sugar, cholesterol, and weight, particularly in adolescents.
  • Monitoring for new or worsening depression or suicidal thoughts, especially in children, adolescents, and young adults on adjunctive treatment.
  • Monitoring for impulse-control changes (gambling, compulsive behaviours).
  • Monitoring for signs of neuroleptic malignant syndrome.
(1) (2)

Storage

Store at room temperature, away from moisture and light, out of reach of children.

Study the drug class: Atypical antipsychotics · Mood stabilisers

Professional information

Clinician-facing context only, sourced from the current US, UK, and Canadian labels; verify against the current full label before prescribing, and note the market-specific indication differences described above.

United States / Canada

Indication: Schizophrenia; bipolar I mania; adjunctive MDD treatment; (US only) autism-related irritability; (US only) Tourette's disorder

Dose summary: Schizophrenia/bipolar mania: 10-15 mg/day initial, up to 30 mg/day. Adjunctive MDD: 2-5 mg/day initial, range 2-15 mg/day, shortest clinically indicated duration. CYP2D6/CYP3A4 interaction-based dose adjustments apply.

Renal context: No dosage adjustment required for renal or hepatic impairment. (1) (3)

United Kingdom / European Union

Indication: Schizophrenia (age 15+); bipolar I mania and relapse prevention (age 13+) -- narrower than US/Canada, no adjunctive MDD, autism, or Tourette's indication

Dose summary: Similar dose ranges to US/Canada for approved indications; same CYP2D6/CYP3A4 interaction-based adjustments.

Renal context: Not separately detailed in the UK SmPC excerpt reviewed. (2)

Mechanism of action

Hepatic guidance

No dosage adjustment required for hepatic impairment.

Overdose note

Manage supportively; monitor cardiac rhythm and level of consciousness, with attention to seizure risk. (1) (3)

Frequently asked questions

Does aripiprazole carry a boxed warning?

Yes -- two, in fact. The current US label carries a boxed warning for increased mortality in elderly patients with dementia-related psychosis (aripiprazole is not approved for this use), and a separate boxed warning for increased risk of suicidal thinking and behaviour in children, adolescents, and young adults taking antidepressants -- directly relevant when aripiprazole is used as an add-on to antidepressant treatment for depression. Health Canada's monograph carries an equivalent warning with a specific figure: a mean 1.6-fold increase in death rate across 13 placebo-controlled trials of atypical antipsychotics in elderly dementia patients. (1) (3)

Is aripiprazole approved for depression everywhere?

No. Aripiprazole is approved as an add-on treatment for major depressive disorder in the United States and Canada, for adults who have not responded adequately to an antidepressant alone. It is NOT an approved use in the United Kingdom or European Union, where aripiprazole is approved only for schizophrenia and bipolar I disorder. (1) (3) (2)

Is aripiprazole approved for autism or Tourette's disorder everywhere?

No. Irritability associated with autistic disorder, and Tourette's disorder, are approved uses in the United States only, in children and adolescents. These are not approved indications in the UK or EU, where the label states there is insufficient safety/efficacy data for these uses. (1) (2)

Why do I need close monitoring if aripiprazole is added to my antidepressant?

Antidepressant medicines carry a known risk of increasing suicidal thinking and behaviour in children, adolescents, and young adults, particularly early in treatment or after a dose change. Because aripiprazole is used as an add-on to antidepressant treatment for depression, this risk applies to that combination and is specifically called out in aripiprazole's own boxed warning. (1)

What is the mechanism of action of aripiprazole?

Aripiprazole's mechanism of action is thought to be mediated through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors, and antagonist activity at serotonin 5-HT2A receptors, distinguishing it from most other antipsychotics that act primarily as dopamine antagonists. (1) (3)

What is the generic name of Aripiprazole?

The generic name is aripiprazole. (1) (2)

What class of drug is aripiprazole?

Aripiprazole is classed as: Atypical antipsychotic (dopamine D2 and serotonin 5-HT1A receptor partial agonist; serotonin 5-HT2A receptor antagonist). (1) (2)

References

  1. ABILIFY (aripiprazole) tablets, for oral use -- full prescribing information (setid c040bd1d-45b7-49f2-93ea-aed7220b30ac)U.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · accessed 2026-07-30 · source 1
  2. Abilify 15 mg tablets -- Summary of Product Characteristics (product 7971)UK Medicines and Healthcare products Regulatory Agency / electronic medicines compendium (emc), Summary of Product Characteristics · United Kingdom · accessed 2026-07-30 · source 2
  3. ARIPIPRAZOLE (Aripiprazole Tablets, 2/5/10/15/20/30 mg) -- Product Monograph, revised 13 January 2026Health Canada -- Sanis Health Inc., product monograph · Canada · accessed 2026-07-30 · source 3
  4. ABILIFY (aripiprazole) oral tablets and ABILIFY MAINTENA/ASIMTUFII long-acting injections -- ARTG registrationsAustralian Therapeutic Goods Administration (TGA), Australian Register of Therapeutic Goods (ARTG) · Australia · accessed 2026-07-30 · source 4
  5. Abilify tablets -- New Zealand Data Sheet (V6.0, February 2022), plus generic Aripiprazole Lupin/Sandoz data sheetsNew Zealand Medicines and Medical Devices Safety Authority (Medsafe) · New Zealand · accessed 2026-07-30 · source 5
  6. Abilify (aripiprazole) -- European Public Assessment Report (EPAR), EU marketing authorisation granted 4 June 2004 (product number EMEA/H/C/000471)European Medicines Agency (EMA) · European Union · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient aripiprazole names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • ABILIFY2 mg, 5 mg, 30 mg, 15 mg, 10 mg, 20 mg · otsuka america pharmaceutical, inc.
  • OPIPZA5 mg, 2 mg, 10 mg · carwin pharmaceutical associates, llc
  • Abilify Asimtufii720 mg/2.4mL, 960 mg/3.2mL · otsuka america pharmaceutical, inc

United Kingdom

  • Abilify (and generic aripiprazole) (2)UK licensed · 5 mg, 10 mg, 15 mg tablets · Otsuka and generic manufacturers

Canada

  • ABILIFY
  • ABILIFY MAINTENA

Australia

  • Abilify (4)TGA ARTG registered · 2 mg, 5 mg, 15 mg, 20 mg · Otsuka Australia Pharmaceutical Pty Ltd
  • Abilify Maintena / Abilify Asimtufii (4)TGA ARTG registered · 300/400 mg; 720/960 mg · Lundbeck Australia Pty Ltd

New Zealand

  • Abilify; Aripiprazole Lupin; Aripiprazole Sandoz (5)Medsafe authorised · multiple oral strengths · multiple Medsafe-registered suppliers
View brands in additional countries.

European Union

Abilify; Abilify Maintena (6)

This page provides general reference information about aripiprazole and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions should be made with your prescriber, especially given the market-specific differences in approved uses described above.

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