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ABILIFY- aripiprazole tabletABILIFY- aripiprazole solutionABILIFY- aripiprazole tablet, orally disintegratingABILIFY- aripiprazole injection, solution


  1. Patient Information
  2. Discuss The Following Issues With Patients Prescribed Abilify:
  3. Call A Healthcare Provider Right Away If You Or Your Family Member Has Any Of The Following Symptoms, Especially If They Are New, Worse, Or Worry You:
  4. What Else Do I Need To Know About Antidepressant Medicines?
  5. Abilify Oral Tablets, Orally-disintegrating Tablets, And Oral Solution Are Prescription Medicines Used To Treat:
  6. Abilify Injection Is A Prescription Medicine Used To Treat:
  7. It Is Not Known If Abilify Is Safe Or Effective In Children:
  8. What Should I Avoid While Taking Abilify?
  9. Abilify May Cause Serious Side Effects, Including:
  10. Active Ingredient:
  11. Tablets:
  12. Abilify Discmelt Orally Disintegrating Tablets:
  13. Abilify Oral Solution:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Discuss The Following Issues With Patients Prescribed Abilify: 

Clinical Worsening of Depression and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behaviorand indicate a need for very close monitoring and possibly changes in the medication[

(For other side effects, also

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call A Healthcare Provider Right Away 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

What Else Do I Need To Know About Antidepressant Medicines? 

  • Never stop an antidepressant medicine without first talking to a healthcare provider.Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses.It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects.Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines.Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children.Talk to your child's healthcare provider for more information.

Abilify Oral Tablets, Orally-disintegrating Tablets, And Oral Solution Are Prescription Medicines Used To Treat: 

  • Schizophrenia
  • manic or mixed episodes that happen with bipolar I disorder
  • major depressive disorder (MDD) when ABILIFY is used with antidepressant medicines
  • irritability associated with autistic disorder
  • Tourette's disorder

Abilify Injection Is A Prescription Medicine Used To Treat: 

  • agitation associated with schizophrenia or bipolar mania

It Is Not Known If Abilify Is Safe Or Effective In Children: 

  • under 13 years of age with schizophrenia
  • under 10 years of age with bipolar I disorder
  • under 6 years of age with irritability associated with autistic disorder
  • under 6 years of age with Tourette's disorder

Do not take ABILIFY if youare allergic to aripiprazole or any of the ingredients in ABILIFY.

  • Take ABILIFY exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking ABILIFY yourself.
  • ABILIFY can be taken with or without food.
  • ABILIFY tablets should be swallowed whole.
  • If you miss a dose of ABILIFY, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of ABILIFY at the same time.
  • If you have been prescribed ABILIFY DISCMELT, take it as follows:
    • Do not open the blister until ready to take the DISCMELT tablet.
    • To remove one DISCMELT tablet, open the package and peel back the foil on the blister to expose the tablet.
    • Do not push the tablet through the foil because this could damage the tablet.
    • Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ABILIFY DISCMELT Orally Disintegrating Tablet on the tongue.
    • Tablet disintegration occurs rapidly in saliva. It is recommended that ABILIFY DISCMELT be taken without liquid. However, if needed, it can be taken with liquid.
    • Do not attempt to split the DISCMELT tablet.
  • If you take too much ABILIFY, call your healthcare provider or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

What Should I Avoid While Taking Abilify? 

  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY affects you. ABILIFY may make you drowsy.
  • Avoid getting over-heated or dehydrated.
    • Do not over-exercise.
    • In hot weather, stay inside in a cool place if possible.
    • Stay out of the sun. Do not wear too much or heavy clothing.
    • Drink plenty of water.

Abilify May Cause Serious Side Effects, Including: 

    • Store ABILIFY at room temperature, between 68 F to 77 F (20 C to 25 C).
    • Opened bottles of ABILIFY Oral Solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.

    Keep ABILIFY and all medicines out of the reach of children.

    General information about the safe and effective use of ABILIFY

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABILIFY for a condition for which it was not prescribed. Do not give ABILIFY to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ABILIFY that was written for healthcare professionals.

Active Ingredient: 

aripiprazole

Tablets: 

cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake

Abilify Discmelt Orally Disintegrating Tablets: 

acesulfame potassium, aspartame (which contains phenylalanine), calcium silicate, croscarmellose sodium, crospovidone, cr me de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake

Abilify Oral Solution: 

disodium edetate, fructose (200 mg per mL), glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose (400 mg per mL), and purified water. The oral solution is flavored with natural orange cream and other natural flavors

For more information about ABILIFY go to www.abilify.com or call 1-800-438-6055.

Tablets manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan
Orally Disintegrating Tablets, Oral Solution, and Injection manufactured by Bristol-Myers Squibb Company, Princeton, NJ 08543 USA
Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA
ABILIFY is a trademark of Otsuka Pharmaceutical Company.

Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan



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