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U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide.

Antidepressants may increase suicidal thoughts or behaviors in some children, teenagers, and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Such symptoms should be reported to the patient's healthcare provider right away, especially if they are severe or occur suddenly. ABILIFY®(aripiprazole) is not approved for use in pediatric patients with depression. See More Safety Information

INDICATION: ABILIFY (aripiprazole) is indicated for the treatment of irritability associated with autistic disorder in pediatric patients 6 to 17 years of age, as part of a total treatment plan.


If your child has been prescribed ABILIFY (aripiprazole), or you wish to discuss it with his or her healthcare professional, it may be helpful to know more about how ABILIFY fits into your child's treatment plan.

Eight-week studies showed that ABILIFY could help improve irritability associated with autistic disorder in children 6 to 17 years of age. Symptoms were measured by improvements on the Irritability Subscale of the Aberrant Behavior Checklist (ABC). This scale includes symptoms such as:

  • Self-harm
  • Aggression
  • Temper tantrums
  • Inappropriate screaming or yelling
  • Depressed mood
  • Quickly changing mood
  • Demanding behavior
  • Crying in response to apparently minor annoyances

As with all medicines, everyone responds differently, and it's
important to give your child’s body time to adapt. If you have questions about the adjustment period, you should talk to your child's healthcare provider before making changes to his or her routine or stopping the medication.

Keep in mind, ABILIFY should be started only after a thorough diagnosis by a healthcare professional and as part of a total treatment program that may include psychological, educational, and social interventions.


Important Safety Information: High fever, stiff muscles, confusion, sweating, changes in pulse, heart rate and blood pressure may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare and serious condition that can lead to death.

See More Safety Information
  • Side Effects FAQs

    Learn the answers to some frequently asked questions about the possible side effects of ABILIFY.