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🏅 FDA Orphan Designation

Abilify

aripiprazole

Manufacturer: Otsuka Pharmaceutical Development

Indicated for:
NON RARE IN EUROPE: Tourette syndromeOrphanRare dystoniaOther dermis disorderChildhood-onset schizophreniaNijmegen breakage syndrome-like disorder
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Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (5)

Treatment of pediatric patients with Tourette's

Irritability Associated with Autistic Disorder

Population: pediatric

Treatment of Tourette's Disorder

Population: pediatric

Schizophrenia

Population: all ages

Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder

Population: all ages

Indications & Usage

1 INDICATIONS AND USAGE ABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's Disorder ( 14.5 )

💙 Support Programs

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ABILIFY MAINTENA
Otsuka
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Abilify Asimtufii
Otsuka
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Where shown, WAC (Wholesale Acquisition Cost) is an estimate only — your actual cost depends on your insurance plan. Always verify pricing with your pharmacy or insurer.

Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.