IMPORTANT SAFETY INFORMATION and INDICATION for ABILIFY:
U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide.

Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with antipsychotic medicines including ABILIFY®(aripiprazole), are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis. See More Safety Information

INDICATION: ABILIFY (aripiprazole) is used for the treatment of manic and mixed episodes associated with bipolar I disorder in adults and in pediatric patients 10 to 17 years of age. It can be used either by itself or as an add-on treatment to lithium or valproate.

The individuals who appear on this page are for illustrative
purposes only. Any person depicted here is a model and not an
actual patient unless otherwise noted.

Side Effects Checklist

Use this checklist to note any side effects of your treatment, and take it to your next appointment with your doctor. Simply check off any side effects you have in each category, then review the full list and click "Print." You should speak with your healthcare provider about any questions you have regarding this checklist or other side effects that you experience.

1 of 6

In the past 2 weeks, have you experienced:

General
The individuals who appear on this page are for illustrative
purposes only. Any person depicted here is a model and not an
actual patient unless otherwise noted.

Side Effects Checklist

Use this checklist to note any side effects of your treatment, and take it to your next appointment with your doctor. Simply check off any side effects you have in each category, then review the full list and click "Print." You should speak with your healthcare provider about any questions you have regarding this checklist or other side effects that you experience.

2 of 6

In the past 2 weeks, have you experienced:

Gastrointestinal (GI)
The individuals who appear on this page are for illustrative
purposes only. Any person depicted here is a model and not an
actual patient unless otherwise noted.

Side Effects Checklist

Use this checklist to note any side effects of your treatment, and take it to your next appointment with your doctor. Simply check off any side effects you have in each category, then review the full list and click "Print." You should speak with your healthcare provider about any questions you have regarding this checklist or other side effects that you experience.

3 of 6

In the past 2 weeks, have you experienced:

Renal and urinary
The individuals who appear on this page are for illustrative
purposes only. Any person depicted here is a model and not an
actual patient unless otherwise noted.

Side Effects Checklist

Use this checklist to note any side effects of your treatment, and take it to your next appointment with your doctor. Simply check off any side effects you have in each category, then review the full list and click "Print." You should speak with your healthcare provider about any questions you have regarding this checklist or other side effects that you experience.

4 of 6

In the past 2 weeks, have you experienced:

Sleep/fatigue
The individuals who appear on this page are for illustrative
purposes only. Any person depicted here is a model and not an
actual patient unless otherwise noted.

Side Effects Checklist

Use this checklist to note any side effects of your treatment, and take it to your next appointment with your doctor. Simply check off any side effects you have in each category, then review the full list and click "Print." You should speak with your healthcare provider about any questions you have regarding this checklist or other side effects that you experience.

5 of 6

In the past 2 weeks, have you experienced:

Muscles and movement
The individuals who appear on this page are for illustrative
purposes only. Any person depicted here is a model and not an
actual patient unless otherwise noted.

Side Effects Checklist

Use this checklist to note any side effects of your treatment, and take it to your next appointment with your doctor. Simply check off any side effects you have in each category, then review the full list and click "Print." You should speak with your healthcare provider about any questions you have regarding this checklist or other side effects that you experience.

6 of 6

In the past 2 weeks, have you experienced:

Mental function
The individuals who appear on this page are for illustrative
purposes only. Any person depicted here is a model and not an
actual patient unless otherwise noted.

Side Effects Checklist

Use this checklist to note any side effects of your treatment, and take it to your next appointment with your doctor. Simply check off any side effects you have in each category, then review the full list and click "Print." You should speak with your healthcare provider about any questions you have regarding this checklist or other side effects that you experience.

Your Side Effects Checklist

Additional notes and questions

Important Safety Information: Decreases in white blood cells (WBC; infection fighting cells) have been reported in some patients taking ABILIFY (aripiprazole). Patients with a history of a significant decrease in WBC count or who have experienced a low WBC count due to drug therapy should have their blood tested and monitored during the first few months of therapy.

See More Safety Information
  • Side Effects FAQs

    Side Effects FAQs

    Learn about the most common side effects
    of ABILIFY (aripiprazole), and how it could
    impact your sleep, weight, and more.

    View questions

FOR BIPOLAR I DISORDER

YOUR SIDE EFFECTS CHECKLIST

This checklist can help you discuss the side effects of your treatment with your doctor or other treatment team members. You should speak with your doctor about this checklist or any other side effects that may not be on this list.

 

INDICATION:
ABILIFY (aripiprazole) is used for the treatment of manic and mixed episodes associated with bipolar I disorder in adults
and in pediatric patients 10 to 17 years of age. It can be used either by itself or as an add-on treatment to lithium or valproate.

Important Warning About Elderly Patients With Dementia-Related Psychosis:
Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with antipsychotic medicines including ABILIFY (aripiprazole), are at an increased
risk of death compared to placebo. ABILIFY is not approved for the treatment of people with
dementia-related psychosis.

Please see IMPORTANT SAFETY INFORMATION on pages 2-3 and U.S. FULL PRESCRIBING INFORMATION,
including Boxed WARNINGS, and Medication Guide at ABILIFY.com.

September 2013 03US13EC0026

IMPORTANT SAFETY INFORMATION for ABILIFY® (aripiprazole)

IMPORTANT SAFETY INFORMATION:

Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with antipsychotic medicines including ABILIFY, are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis (see Boxed WARNING).

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 is not approved for use in pediatric patients with depression (see Boxed WARNING).

Contraindication: Patients should not use ABILIFY if they are allergic to aripiprazole or any of the ingredients in
ABILIFY. Allergic reactions have ranged from rash, hives and itching to anaphylaxis, which may include difficulty
breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.

Serious side effects may include:

  • An increased risk of stroke and ministroke have been reported in clinical studies of elderly people with dementia-
    related psychosis
  • 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
  • Increases in blood sugar levels (hyperglycemia) can happen in some people who take ABILIFY. Extremely high
    blood sugar can lead to coma or death. If you have diabetes, or risk factors (for example, obesity, family history of
    diabetes), or have the following symptoms: increases in thirst, urination, or hunger, feel weak or tired, sick to your
    stomach, or confused (or breath smells fruity), your blood sugar should be monitored
  • Changes in cholesterol and triglyceride (fat, also called lipids) levels in the blood have been seen in patients
    taking medicines like ABILIFY
  • Weight gain has been reported in patients taking medicines like ABILIFY so your weight should be checked regularly. Weight gain in children (ages 6 to 17) should be compared against that expected with normal growth
  • ABILIFY and medicines like it have been associated with difficulty swallowing which may lead to aspiration or
    choking
  • Uncontrollable movements of face, tongue, or other parts of body, as these may be signs of a serious condition
    called tardive dyskinesia (TD). TD may not go away, even if you stop taking ABILIFY. TD may also start after you stop
    taking ABILIFY
  • Orthostatic hypotension (decreased blood pressure) or lightheadedness or fainting when rising too quickly from a
    sitting or lying position has been reported with ABILIFY
  • Decreases in white blood cells (WBC; infection fighting cells) have been reported in some patients taking ABILIFY.
    Patients with a history of a significant decrease in WBC count or who have experienced a low WBC count due to drug
    therapy should have their blood tested and monitored during the first few months of therapy
  • Seizures (convulsions) have been reported with ABILIFY. Tell your healthcare provider if you have a history of or are
    at risk for seizures
  • ABILIFY and medicines like it can affect your judgment, thinking, or motor skills. You should not drive or operate
    hazardous machinery until you know how ABILIFY affects you
  • Medicines like ABILIFY can impact your body’s ability to reduce body temperature; you should avoid overheating and dehydration
  • Tell your healthcare provider if you are pregnant or intend to become pregnant. Also tell your healthcare provider
    about any other medical conditions you have and about all prescription and non-prescription medicines you are
    taking or plan to take since there are some risks for drug interactions

While taking ABILIFY, avoid:

  • Drinking alcohol
  • Breast-feeding an infant

Most common side effects (≥10%) from all clinical trials involving adults or pediatric patients include:

  • ADULTS: Nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety, insomnia, and restlessness
  • PEDIATRIC PATIENTS (6 to 17 years): Sleepiness, headache, vomiting, extrapyramidal disorder (for example, uncontrolled movement disorders or muscle disturbances such as restlessness, tremors and muscle stiffness),
    fatigue, increased appetite, insomnia, nausea, stuffy nose, and weight gain

IMPORTANT SAFETY INFORMATION continued on next page.

September 2013 03US13EC0026


IMPORTANT SAFETY INFORMATION (continued) and INDICATION for ABILIFY® (aripiprazole)

It is important to contact your healthcare provider if you experience prolonged, abnormal muscle spasms or contractions, which may be signs of a condition called dystonia.

For patients with phenylketonuria or PKU, ABILIFY DISCMELT® (aripiprazole) contains phenylalanine.

If you have any questions about your health or medicines, talk to your healthcare provider.

INDICATION: ABILIFY is indicated for:

  • Treatment of manic or mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients 10 to 17
    years of age, and as an adjunct to lithium or valproate

Special Considerations for Pediatric Uses:

  • Discuss the risks and benefits of treatment with your child’s healthcare provider. Treatment should be started only
    after a thorough diagnostic evaluation and as part of a total treatment program

Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide at ABILIFY.com.

Tablets manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo 101-8535, Japan or Bristol-Myers Squibb Company,
Princeton, NJ 08543 USA. Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA.

Otuska Logo

© 2013 Otsuka America Pharmaceutical, Inc., Rockville, MD

September 2013 03US13EC0026