ABILIFY
IMPORTANT SAFETY INFORMATION: Children, adolescents, and young adults taking antidepressants for Major Depressive Disorder (MDD) and other psychiatric disorders are at an increased risk of suicidal thinking and behavior. More

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

IMPORTANT SAFETY INFORMATION for ABILIFY: U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNING, 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

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Talk to your doctor about all your medicines

Be sure to tell your doctor about any other medications you're on including prescription medicines, non-prescription medicines, herbal supplements, and vitamins. ABILIFY may interact with other medications, which could affect the way that each one works. Your doctor can tell you if it is safe to take ABILIFY with your other medicines. He or she can also tell you if you should start or stop any other medications while you're on ABILIFY.

Report any side effects to your doctor

Everyone responds differently to medication. Serious side effects have been reported with ABILIFY. Take note of any side effects you experience, and report them to your doctor. This will help your doctor understand how to manage your side effects.

Call your doctor if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • Thoughts about suicide or dying
  • Attempts to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling very agitated or restless
  • Panic attacks
  • Trouble sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking (mania)
  • Other unusual changes in behavior or mood
See More Safety Information

Know what to avoid while taking ABILIFY

  • ABILIFY may make you drowsy. So do not drive, operate heavy machinery, or perform other dangerous activities until you know how ABILIFY affects you
  • Do not drink alcohol while taking ABILIFY
  • Avoid breast-feeding. Talk to your healthcare provider about the best way to feed your baby if you take ABILIFY
  • Avoid getting over-heated or dehydrated
    • Do not over-exercise
    • In hot weather, try to stay inside or in the shade, and don't wear heavy clothing
    • Drink plenty of water

Stay on schedule

ABILIFY is usually taken once a day, with or without food. You may want to ask your doctor for advice on what time of day to take ABILIFY. But remember to always take ABILIFY as directed by your doctor.

Taking ABILIFY regularly may help you get the best results from your treatment. And to help yourself stay on your prescribed schedule, there are a few things you may find helpful:

  • Try making your medication part of your daily routine
  • Mark your dose on a calendar or to-do list
  • Use a childproof weekly pillbox to keep your ABILIFY pills in order
  • Ask a friend or family member to help remind you

Don't stop taking ABILIFY without talking to your doctor

Even if you start to feel better, it's important to keep taking ABILIFY as prescribed by your doctor. It may take time to feel the effect of ABILIFY, so don't change your routine or stop taking ABILIFY without talking to your doctor first.

Know what to do if you miss a dose

If you miss a dose, take your ABILIFY as soon as you remember. However, if it's almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose. If you miss several doses, talk to your doctor right away.

Keep your doctor informed

Consider using a journal to record how you're feeling each day so you can compare it to how you felt before taking ABILIFY. Be sure to share your results with your doctor, including any side effects. This way, your doctor will better understand what effect your treatment is having and be able to adjust it if necessary.

Make the most of your support system

Family and friends can provide a helping hand and be a much-needed source of encouragement. Don't be afraid to reach out, and accept support when you need it.

Did you know?

ABILIFY has been FDA
approved for over 10 years.

Pay as little as $5 a month for ABILIFY*

Tips for Family and Friends

Providing support and helping your loved one stay on schedule may help him or her get more out of treatment.

INDICATIONS: ABILIFY (aripiprazole) is indicated for:

  • Use as an add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy
  • Treatment of manic or mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients 10 to 17 years of age
  • Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age
  • Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age

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

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 (aripiprazole), are at an increased risk of death compared to placebo. ABILIFY (aripiprazole) 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 (aripiprazole) is not approved for use in pediatric patients with depression (see Boxed WARNING).

Contraindication: Patients should not use ABILIFY (aripiprazole) if they are allergic to aripiprazole or any of the ingredients in ABILIFY (aripiprazole). 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 (aripiprazole). 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 (aripiprazole)
  • Weight gain has been reported in patients taking medicines like ABILIFY (aripiprazole) 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 (aripiprazole) 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 (aripiprazole). TD may also start after you stop taking ABILIFY (aripiprazole)
  • Orthostatic hypotension (decreased blood pressure) or lightheadedness or fainting when rising too quickly from a sitting or lying position has been reported with ABILIFY (aripiprazole)
  • 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
  • Seizures (convulsions) have been reported with ABILIFY (aripiprazole). Tell your healthcare provider if you have a history of or are at risk for seizures
  • ABILIFY (aripiprazole) 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 (aripiprazole) affects you
  • Medicines like ABILIFY (aripiprazole) 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 (aripiprazole), 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

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 who must limit their sugar intake, ABILIFY (aripiprazole) Oral Solution contains sugar.

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.

You are encouraged to report side effects of ABILIFY (aripiprazole). Please contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNING, and Medication Guide for ABILIFY.

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