Abilify

Storage

Oral

25°C (may be exposed to 15–30°C).1

25°C (may be exposed to 15–30°C).1

25°C (may be exposed to 15–30°C).1 After opening, can use for up to 6 months (but not beyond expiration date).1

Parenteral

25°C (may be exposed to 15–30°C).1 Store in original carton until time of use; protect from light.1 Discard any unused portion.1

Prefilled dual-chamber syringe: <30°C.118 Do not freeze.118 Protect syringe from light; store in original package until time of use.118

Vial: 25°C (may be exposed to 15–30°C).118

20–25°C (may be exposed to 15–30°C).119

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

• Importance of providing copy of written patient information (medication guide) each time aripiprazole is dispensed.1 76 77 78 118 119 Importance of advising patients to read the patient information before taking aripiprazole and each time the prescription is refilled.1 76 118 119

• Importance of advising patients and caregivers that geriatric patients with dementia-related psychosis treated with antipsychotic agents are at an increased risk of death.1 28 73 98 113 118 119 Inform patients and caregivers that aripiprazole is not approved for treating geriatric patients with dementia-related psychosis.1 73 98 118 119

• Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, manic or hypomanic symptoms, irritability, agitation, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.1 76 77 78

• Risk of somnolence and impairment of judgment, thinking, or motor skills; avoid driving, operating machinery, or performing hazardous tasks until effects on the individual are known.1 118 119

• Importance of avoiding alcohol during extended-release IM aripiprazole (Abilify Maintena) therapy.118

• Importance of informing patients and caregivers about the risk of NMS; importance of immediately contacting clinician or seeking emergency medical attention if signs and symptoms of this rare but potentially life-threatening syndrome develop (e.g., high fever, muscle stiffness, sweating, fast or irregular heart beat, change in BP, confusion, kidney damage).1 118 119

• Importance of informing patients of risk of tardive dyskinesia if chronic use is contemplated.1 98 118 119 Importance of informing patients to report any muscle movements that cannot be stopped to a healthcare professional.98 118 119

• Risk of leukopenia/neutropenia.1 118 119 Importance of advising patients with a preexisting low WBC count or history of drug-induced leukopenia/neutropenia of need for CBC monitoring during aripiprazole therapy.1 118 119

• Importance of informing patients and caregivers about the risk of metabolic changes (e.g., hyperglycemia and diabetes mellitus, dyslipidemia, weight gain) and the need for specific monitoring for such changes.1 118 119 Importance of patients and caregivers being aware of the symptoms of hyperglycemia and diabetes mellitus (e.g., increased thirst, increased urination, increased appetite, weakness).1 118 119

• Importance of asking patients whether they have developed any new or increased urges or compulsive behaviors (e.g., gambling urges, sexual urges, uncontrolled spending or shopping, binge eating) while receiving aripiprazole.123 Advise patients or their caregivers to promptly report any such urges that seem out of the ordinary; also advise patients not to abruptly stop taking aripiprazole without first consulting their clinician.123

• Risk of orthostatic hypotension and syncope, especially when initiating or reinitiating treatment or increasing the dosage.1 118 119

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease, diabetes mellitus, seizures).1 98

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 108 Importance of clinicians informing patients about the benefits and risks of taking antipsychotics during pregnancy (see Pregnancy under Cautions).1 108 Importance of advising patients not to stop taking aripiprazole if they become pregnant without consulting their clinician; abruptly discontinuing antipsychotic agents may cause complications.108 Importance of advising patients not to breast-feed during aripiprazole therapy.1

• Importance of avoiding overheating or dehydration.1 118 119

• For patients taking aripiprazole orally disintegrating tablets, importance of not removing a tablet from the blister package until just before administering a dose; importance of peeling blister open with dry hands and placing tablet on tongue to dissolve and be swallowed with saliva.1

• Importance of informing patients with phenylketonuria that aripiprazole orally disintegrating 10- and 15-mg tablets (Abilify Discmelt) contain 1.12 and 1.68 mg of phenylalanine, respectively.1

• Importance of being aware that aripiprazole oral solution contains 400 mg of sucrose and 200 mg of fructose per mL.1

• Importance of informing patients of other important precautionary information.1 118 119 (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Controlled Substance

Abilify is not a controlled substance.

Abuse

Abilify has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of Abilify misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior).

Dependence

In physical dependence studies in monkeys, withdrawal symptoms were observed upon abrupt cessation of dosing. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed.

MedDRA terminology has been used to classify the adverse reactions.

Human Experience

In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral Abilify have been reported worldwide. These include overdoses with oral Abilify alone and in combination with other substances. No fatality was reported with Abilify alone. The largest known dose with a known outcome involved acute ingestion of 1260 mg of oral Abilify (42 times the maximum recommended daily dose) by a patient who fully recovered. Deliberate or accidental overdosage was also reported in children (age 12 and younger) involving oral Abilify ingestions up to 195 mg with no fatalities.

Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral Abilify overdosage (alone or in combination with other substances) include vomiting, somnolence, and tremor. Other clinically important signs and symptoms observed in one or more patients with Abilify overdoses (alone or with other substances) include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia.

Management of Overdosage

No specific information is available on the treatment of overdose with Abilify. An electrocardiogram should be obtained in case of overdosage and if QT interval prolongation is present, cardiac monitoring should be instituted. Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms. Close medical supervision and monitoring should continue until the patient recovers.

Charcoal: In the event of an overdose of Abilify, an early charcoal administration may be useful in partially preventing the absorption of aripiprazole. Administration of 50 g of activated charcoal, one hour after a single 15 mg oral dose of Abilify, decreased the mean AUC and Cmax of aripiprazole by 50%.

Hemodialysis: Although there is no information on the effect of hemodialysis in treating an overdose with Abilify, hemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.

See 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 behavior and indicate a need for very close monitoring and possibly changes in the medication[see WARNINGS AND PRECAUTIONS (5.3)].

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Abilify and should counsel them in its appropriate use. A patient Medication Guide including information about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for Abilify. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. It should be noted that Abilify is not approved as a single agent for treatment of depression and has not been evaluated in pediatric major depressive disorder.

Pathological Gambling and Other Compulsive Behaviors

Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking aripiprazole. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped [see WARNINGS AND PRECAUTIONS (5.7)].

Use of Orally Disintegrating Tablet

Do not open the blister until ready to administer. For single tablet removal, 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 tablet.

Interference with Cognitive and Motor Performance

Because Abilify may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Abilify therapy does not affect them adversely [see WARNINGS AND PRECAUTIONS (5.12)].

Nursing

Advise patients that breastfeeding is not recommended with Abilify treatment because of the potential for serious adverse reactions in a nursing infant [see USE IN SPECIFIC POPULATIONS (8.3)].

Concomitant Medication

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see DRUG INTERACTIONS (7)].

Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see WARNINGS AND PRECAUTIONS (5.13)].

Sugar Content

Patients should be advised that each mL of Abilify Oral Solution contains 400 mg of sucrose and 200 mg of fructose.

Phenylketonurics

Phenylalanine is a component of aspartame. Each Abilify DISCMELT Orally Disintegrating Tablet contains the following amounts: 10 mg, 1.12 mg phenylalanine and 15 mg, 1.68 mg phenylalanine.

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.

Rev 02/2017

© 2017, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan

• Carbamazepine (Tegretol) can markedly decrease the amount of Abilify in the body by increasing the rate at which the body's enzymes (particularly the liver enzyme, CYP3A4) degrade it. The manufacturer recommends that patients on this drug who are started on carbamazepine double their dose of Abilify, under their doctor's supervision. Other drugs that can promote the activity of CYP3A4 and decrease the body's levels of Abilify are phenytoin (Dilantin), rifampin (Rifadin, Rimactane, Rifadin, Rifater, Rifamate), and phenobarbital.
• Ketoconazole (Nizoral) can increase the amount of aripiprazole in the body by blocking CYP3A4. The manufacturer of aripiprazole recommends reducing the dose of aripiprazole by one-half during ketoconazole therapy. Many other drugs also are known to block CYP3A4 and potentially could increase the levels of aripiprazole, but their actual effects on aripiprazole levels have not been studied. Such drugs include:
  • itraconazole (Sporanox)
  • fluconazole (Diflucan)
  • voriconazole (Vfend)
  • cimetidine (Tagamet)
  • verapamil (Calan, Isoptin)
  • diltiazem (Cardizem, Dilacor)
  • erythromycin clarithromycin (Biaxin)
  • nefazodone (Serzone)
  • ritonavir (Norvir)
  • saquinavir (Invirase)
  • nelfinavir (Viracept)
  • indinavir (Crixivan)
  • Grapefruit juice
• Quinidine (Quinaglute, Quinidex) inhibits another liver enzyme known as CYP2D6 that also breaks down aripiprazole and can increase the amount of aripiprazole in the body. The manufacturer of aripiprazole recommends reducing the dose of aripiprazole by one-half during quinidine therapy. Other medicines that block CYP2D6 include fluoxetine (Prozac) and paroxetine (Paxil).
• Alpha-1 receptor blockers [doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin)], used for control of blood pressure and prostatic enlargement, may increase the chance of hypotension (unusually low blood pressure).

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

MedDRA terminology has been used to classify the adverse reactions.

Human Experience

In clinical trials and in postmarketing experience, adverse reactions of deliberate or accidental overdosage with oral ABILIFY have been reported worldwide.

These include overdoses with oral ABILIFY alone and in combination with other substances. No fatality was reported with ABILIFY alone. The largest known dose with a known outcome involved acute ingestion of 1260 mg of oral ABILIFY (42 times the maximum recommended daily dose) by a patient who fully recovered. Deliberate or accidental overdosage was also reported in children (age 12 and younger) involving oral ABILIFY ingestions up to 195 mg with no fatalities.

Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral ABILIFY overdosage (alone or in combination with other substances) include vomiting, somnolence, and tremor. Other clinically important signs and symptoms observed in one or more patients with ABILIFY overdoses (alone or with other substances) include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia.

Management Of Overdosage

No specific information is available on the treatment of overdose with ABILIFY. An electrocardiogram should be obtained in case of overdosage and if QT interval prolongation is present, cardiac monitoring should be instituted. Otherwise, management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms. Close medical supervision and monitoring should continue until the patient recovers.

Charcoal: In the event of an overdose of ABILIFY, an early charcoal administration may be useful in partially preventing the absorption of aripiprazole. Administration of 50 g of activated charcoal, one hour after a single 15 mg oral dose of ABILIFY, decreased the mean AUC and Cmax of aripiprazole by 50%.

Hemodialysis: Although there is no information on the effect of hemodialysis in treating an overdose with ABILIFY, hemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.

ABILIFY®
(aripiprazole) Tablets

ABILIFY DISCMELT®
(aripiprazole) Orally Disintegrating Tablets

ABILIFY®
(aripiprazole) Oral Solution

ABILIFY®
(aripiprazole) Injection For Intramuscular Use Only

What is the most important information I should know about ABILIFY?

(For other side effects, also see “What are the possible side effects of ABILIFY?”) Serious side effects may happen when you take ABILIFY, including:

• Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ABILIFY can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY is not approved for the treatment of patients with dementia-related psychosis.
• Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

1.Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2.Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• 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.

What is ABILIFY?

• 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 you are allergic to aripiprazole or any of the ingredients in ABILIFY. See the end of this Medication Guide for a complete list of ingredients in ABILIFY.

Before taking ABILIFY, tell your healthcare provider about all your medical conditions, including if you have or had:

• diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start ABILIFY and also during therapy.
• seizures (convulsions).
• low or high blood pressure.
• heart problems or stroke.
• pregnancy or plans to become pregnant. It is not known if ABILIFY will harm your unborn baby.
• breast-feeding or plans to breast-feed. ABILIFY can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ABILIFY.
• low white blood cell count.
• phenylketonuria. ABILIFY DISCMELT Orally Disintegrating Tablets contain phenylalanine.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

ABILIFY and other medicines may affect each other causing possible serious side effects. ABILIFY may affect the way other medicines work, and other medicines may affect how ABILIFY works.

Your healthcare provider can tell you if it is safe to take ABILIFY with your other medicines. Do not start or stop any medicines while taking ABILIFY without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take 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.

What are the possible side effects of ABILIFY?

ABILIFY may cause serious side effects, including:

• See “What is the most important information I should know about ABILIFY?”
• Stroke in elderly people (cerebrovascular problems) that can lead to death
• Neuroleptic malignant syndrome (NMS). Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.
• Uncontrolled body movements (tardive dyskinesia). ABILIFY may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ABILIFY. Tardive dyskinesia may also start after you stop receiving ABILIFY.
• Problems with your metabolism such as:
  • High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar 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 diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start ABILIFY and during your treatment.
    Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving ABILIFY:
    • feel very thirsty
    • need to urinate more than usual
    • feel very hungry
    • feel weak or tired
    • feel sick to your stomach
    • feel confused, or your breath smells fruity
  • Increased fat levels (cholesterol and triglycerides) in your blood.
  • Weight gain. You and your healthcare provider should check your weight regularly.
• Unusual urges. Some people taking ABILIFY have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
• Orthostatic hypotension (decreased blood pressure). Lightheadedness or fainting may happen when rising too quickly from a sitting or lying position.
• Low white blood cell count
• Seizures (convulsions)
• Problems with control of your body temperature especially when you exercise a lot or are in an area that is very hot. It is important for you to drink water to avoid dehydration. See “What should I avoid while receiving ABILIFY?”
• Difficulty swallowing that can cause food or liquid to get into your lungs.

The most common side effects of ABILIFY in adults include:

• nausea
• dizziness
• vomiting
• anxiety
• constipation
• insomnia
• headache
• restlessness
• blurred vision
• upper respiratory illness
• inner sense of restlessness/need to move (akathisia)

The most common side effects of ABILIFY in children include:

• feeling sleepy
• insomnia
• headache
• nausea
• vomiting
• stuffy nose
• fatigue
• weight gain
• increased or decreased appetite
• uncontrolled movement such as restlessness, tremor
• increased saliva or drooling
• muscle stiffness

These are not all the possible side effects of ABILIFY.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ABILIFY?

• 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.

What are the ingredients in ABILIFY?

Active ingredient: aripiprazole

Inactive ingredients:

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, crème 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.

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antidepressants (mood elevators)
• antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• antihistamines
• bupropion (Wellbutrin)
• carbamazepine (Tegretol)
• clarithromycin (Biaxin)
• fluoxetine (Prozac, Sarafem)
• HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• ipratropium (Atrovent)
• medications for anxiety, high blood pressure, irritable bowel syndrome, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
• nefazodone (Serzone)
• paroxetine (Paxil, Pexeva)
• quinidine (Cardioquine, Quinact, Duraquin)
• rifampin (Rifadin, Rimactane)
• sedatives
• sleeping pills
• telithromycin (Ketek)
• tranquilizers

This is not a complete list of Abilify drug interactions. Ask your doctor or pharmacist for more information.

Take Abilify exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The recommended dose varies depending upon which condition is being treated as well as other factors.

Abilify tablets and oral solution

The recommended dose range for Abilify is 5 mg -15 mg per day. The maximum dose per day is 30 mg.

The target dose for adolescents is 10 mg/day.

Your doctor will start you on a smaller dose and then increase the dose to a target dose.

Abilify immediate release injection

The recommended dose is 9.75 mg injected into the muscle (IM) once. If another dose is needed, the second dose can be administered 2 hours later. The maximum dose of Abilify per day is 30 mg.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Abilify (aripiprazole is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Abilify is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar I disorder (manic depression). It is not known if aripiprazole is safe or effective in children younger than 13 with schizophrenia, or children younger than 10 with bipolar disorder.

Abilify is also used together with other medicines to treat major depressive disorder in adults.

Abilify is also used in children 6 years or older who have Tourette's disorder, or symptoms of autistic disorder (irritability, aggression, mood swings, temper tantrums, and self-injury).

Get emergency medical help if you have signs of an allergic reaction to Abilify: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;

• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

• mask-like appearance of the face, trouble swallowing, problems with speech;

• seizure (convulsions);

• thoughts about suicide or hurting yourself;

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• low blood cell counts--sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, red or swollen gums, skin sores, cold or flu symptoms, cough, trouble breathing; or

• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, weight loss.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Abilify side effects may include:

• weight gain;

• blurred vision;

• nausea, vomiting, changes in appetite, constipation;

• drooling;

• headache, dizziness, drowsiness, feeling tired;

• anxiety, feeling restless;

• sleep problems (insomnia); or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

More frequent side effects include: dizziness, drowsiness, lethargy, sedation, urinary incontinence, and salivation. See below for a comprehensive list of adverse effects.

Applies to aripiprazole: intramuscular powder for injection extended release, intramuscular solution, intramuscular suspension extended release, oral solution, oral tablet, oral tablet disintegrating

General

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension: The most commonly reported side effects included akathisia, headache, injection site reactions, and insomnia.

Aripiprazole Extended/Prolonged-Release IM Suspension: The most commonly reported side effects included increased weight, headache, akathisia, and insomnia.

Immediate-Release IM Injection: The most commonly reported side effects included extrapyramidal symptoms, headache, nausea, and dizziness.

Oral Formulations: The most commonly reported side effects included extrapyramidal disorder, headache, and somnolence.[Ref]

Psychiatric

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Insomnia, restlessness
Frequency not reported: Anxiety, other compulsive behaviors, suicide
Postmarketing reports: Pathological gambling

Aripiprazole Extended/Prolonged-Release IM Suspension:
Very common (10% or more): Insomnia (up to 10.9%)
Common (1% to 10%): Agitation, anxiety, depression, psychotic disorder, restlessness, schizophrenia
Uncommon (0.1% to 1%): Affect lability, apathy, bruxism, decreased libido, delusion, dysphoria, hallucination, hypersexuality, irritability, mood altered, panic reaction, psychotic behavior, sleep disorder, suicidal ideation
Rare (0.01% to 0.1%): Aggression, panic attack
Frequency not reported: Abnormal dreams, bulimia nervosa, completed suicide, hallucination auditory, hyposomnia, middle insomnia, neonatal drug withdrawal syndrome, nervousness, nightmare, other compulsive behaviors, poor quality sleep, suicide attempt, tension
Postmarketing reports: Eating disorder, impulse-control disorders, obsessive-compulsive disorder, pathological gambling

Immediate-Release IM Injection:
Common (1% to 10%): Anxiety, insomnia, restlessness
Uncommon (0.1% to 1%): Depression, hypersexuality
Frequency not reported: Aggression, agitation, anorgasmia, catatonia, completed suicide, delirium, homicidal ideation, libido increased, loss of libido, neonatal drug withdrawal syndrome, nervousness, pathological gambling, sleep talking, sleep walking, suicide attempt, suicidal ideation, tic

Oral Formulations:
Very common (10% or more): Agitation (up to 19%), insomnia (up to 18%), anxiety (up to 17%), restlessness (up to 12%)
Common (1% to 10%): Irritability, suicidal ideation
Uncommon (0.1% to 1%): Abnormal dreams, aggression, anger, anorgasmia, apathy, bruxism, completed suicide, confusional state, delirium, depression, hallucination, hallucination auditory, homicidal ideation, hostility, hypersexuality, intentional self-injury, libido increased, loss of libido, mania, nervousness, nightmare, self-mutilation, suicide attempt, thinking abnormal, tic
Rare (0.01% to 0.1%): Asthenia, blunted affect, bradyphrenia, catatonia, cognitive deterioration, delirium, delusional perception, depressed mood, disorientation, eating disorder, emotional distress, euphoric mood, impulsive behavior, logorrhea, mental status changes, mood altered, mood swings, panic attack, psychomotor retardation, sleep disorder, sleep walking, somatoform disorder
Frequency not reported: Drug withdrawal syndrome neonatal, sleep talking
Postmarketing reports: Impulse-control disorders, obsessive-compulsive disorders, pathological gambling[Ref]

Nervous system

Elderly patients (mean = 84 years old) enrolled in placebo-controlled studies examining the use of aripiprazole (the active ingredient contained in Abilify) for the treatment of dementia-related psychosis showed an increased incidence of cerebrovascular side effects, e.g. stroke and transient ischemia attacks, including fatalities. The incidence of these effects may be dose related.

In a dose response analysis, somnolence including sedation was the only adverse reaction determined to have a dose response relationship in adult patients. Somnolence was reported in 12.6% of adult patients with schizophrenia receiving the 30 mg dose.

In pediatric patients 13 to 17 years of age, extrapyramidal disorder, somnolence, and tremor displayed possible dose response relationship in patients with schizophrenia, while extrapyramidal disorder, somnolence, and akathisia displayed possible dose response relationship in pediatric patients with bipolar mania.

Extrapyramidal symptoms were more prevalent with use of the extended-release IM injection compared with oral formulations (18.4% versus 11.7%). Akathisia was the most frequently observed adverse event with the extended-release IM injection; it typically starts around day 10 and lasts a median of 56 days.[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:
Very common (10% or more): Akathisia (up to 11%)
Common (1% to 10%): Dystonia, extrapyramidal symptoms (EPS), headache, other EPS-related events, parkinsonism
Frequency not reported: Cerebrovascular adverse reactions, cognitive/motor impairment, dizziness, increased mortality in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, seizures, stroke, tardive dyskinesia

Aripiprazole Extended/Prolonged-Release IM Suspension:
Very common (10% or more): EPS (up to 18.4%), headache (up to 14.4%), akathisia (up to 11.5%)
Common (1% to 10%): Dizziness, dyskinesia, extrapyramidal disorder, parkinsonism, sedation, somnolence, tremor
Uncommon (0.1% to 1%): Bradykinesia, cogwheel rigidity, drooling, dysgeusia, dystonia, gait disturbance, hypersomnia, hypertonia, lethargy, movement disorder, parosmia, psychomotor hyperactivity, restless legs syndrome, tardive dyskinesia
Rare (0.01% to 0.1%): Convulsion, memory impairment, oromandibular dystonia
Frequency not reported: Cerebrovascular adverse reaction, cognitive/motor impairment, diabetic hyperosmolar coma, disturbance in attention, grand mal convulsion, hypoesthesia, increased mortality in elderly patients with dementia-related psychosis, migraine, neuroleptic malignant syndrome, seizures, serotonin syndrome, sinus headache, speech disorder, stroke, syncope, tension headache, vertigo

Immediate-Release IM Injection:
Very common (10% or more): EPS (up to 25.8%), headache (up to 12%)
Common (1% to 10%): Akathisia, dizziness, extrapyramidal disorder, sedation, somnolence, tremor
Uncommon (0.1% to 1%): Dystonia, tardive dyskinesia
Frequency not reported: Akinesia, bradykinesia, choreoathetosis, cogwheel rigidity, coordination abnormal, diabetic hyperosmolar coma, grand mal convulsion, hypokinesia, memory impairment, myoclonus, neuroleptic malignant syndrome, parkinsonism, serotonin syndrome, speech disorder, syncope

Oral Formulations:
Very common (10% or more): Extrapyramidal disorder (up to 27.3), headache (up to 27%), somnolence (up to 26.3%), EPS (up to 25.8%), akathisia (up to 25%), sedation (up to 21%), tremor (up to 11.8%)
Common (1% to 10%): Coordination abnormal, disturbance in attention, dizziness, drooling, dystonia, lethargy
Uncommon (0.1% to 1%): Akinesia, bradykinesia, cerebrovascular accident, cogwheel rigidity, dysarthria, gait disturbance, hypertonia, hypoesthesia, hypokinesia, hypotonia, memory impairment, myoclonus, paresthesia, parkinsonism, postural hypotension, psychomotor hyperactivity, speech disorder, tardive dyskinesia
Rare (0.01% to 0.1%): Akinesthesia, ataxia, burning sensation, choreoathetosis, coma, convulsion, depressed level of consciousness, difficulty in walking, dysgeusia, dysphagia, facial palsy, grand mal convulsion, judgement impaired, loss of consciousness, migraine, neuroleptic malignant syndrome, phase sleep rhythm disturbance, positional vertigo, serotonin syndrome, unresponsive to verbal stimuli
Frequency not reported: Diabetic hyperosmolar coma, syncope[Ref]

Metabolic

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Increased weight
Frequency not reported: Metabolic changes
Postmarketing reports: Blood glucose fluctuation

Aripiprazole Extended/Prolonged-Release IM Suspension:
Very common (10% or more): Increased weight (up to 21.5%)
Common (1% to 10%): Decreased weight, decreased appetite, diabetes mellitus, waist circumference increased
Uncommon (0.1% to 1%): Appetite disorder, blood cholesterol decreased, blood glucose decreased/increased, blood triglycerides decreased, glycosylated hemoglobin increased, hypercholesterolemia, hyperglycemia, hyperinsulinemia, hyperlipidemia, hypertriglyceridemia, obesity, thirst, waist circumference increased
Frequency not reported: Anorexia, blood insulin increased, diabetic ketoacidosis, gout, hyperuricemia, hypoglycemia, hyponatremia, increased appetite, lactate dehydrogenase increased, metabolic changes, overweight, type 2 diabetes mellitus
Postmarketing reports: Blood glucose fluctuation

Immediate-Release IM Injection:
Common (1% to 10%): Diabetes mellitus
Uncommon (0.1% to 1%): Hyperglycemia
Frequency not reported: Anorexia, blood glucose fluctuated, blood glucose increased, blood insulin increased, blood lactate dehydrogenase increased, diabetic ketoacidosis, glycosylated hemoglobin increased, hypoglycemia, hypokalemia, hyponatremia, weight gain/loss

Oral Formulations:
Common (1% to 10%): Decreased appetite, increased appetite, weight decreased, weight increased
Uncommon (0.1% to 1%): Anorexia, blood glucose increased, carbohydrate tolerance decreased, blood insulin increased, blood lactate dehydrogenase increased, dehydration, diabetes mellitus, diabetes mellitus non-insulin-dependent, glucose tolerance impaired, glycosuria, glycosylated hemoglobin increased, hyperglycemia, hyperlipidemia, hypoglycemia, hypokalemia, hyponatremia, increased appetite, polydipsia
Rare (0.01% to 0.1%): Thirst
Frequency not reported: Diabetic ketoacidosis, hyponatremia
Postmarketing reports: Blood glucose fluctuation[Ref]

Reports of diabetes mellitus included increases in blood insulin, decreases in carbohydrate tolerance, non-insulin dependent diabetes mellitus, impaired glucose tolerance, and glycosuria.

Analysis of 13 placebo-controlled monotherapy trials in adult patients primarily with schizophrenia or bipolar disorder revealed a mean increase in fasting blood glucose of 4.4 mg/dL with a median exposure of 25 days. This was not significantly different from placebo (+2.5 mg/dL, median exposure 22 days). A pooled analysis in pediatric patients revealed a mean change in fasting glucose of 2.4 mg/dL compared with 0.1 mg/dL in placebo treated patients following 12 weeks of therapy. In long-term, open label schizophrenia studies with aripiprazole lauroxil, 14% of patients with HbA1c less than 5.7% at baseline developed levels of 5.7% or higher post-baseline.

Undesirable alterations in lipids have been observed in patients receiving atypical antipsychotics. Analyses of patients receiving this drug are limited due to the small number of patients who received this drug for extended periods in the clinical trials. In long-term, open label schizophrenia studies with aripiprazole lauroxil, shifts in fasting total cholesterol, LDL, and triglycerides from normal to high were reported in 1%, 1%, and 8% of patients.

Weight gain has been observed in patients receiving atypical antipsychotics. Analysis of 13 placebo-controlled monotherapy trials in adult patients primarily with schizophrenia or bipolar disorder revealed a mean change in weight of +0.3 kg (n=1673) with a median exposure of 21 to 25 days compared with a decrease of 0.1 kg in placebo treated patients (n=1100). A pooled analysis in pediatric patients (10 to 17 years) revealed a mean change in weight of +5.8 kg (n=62) compared with +1.4 kg (n=13) in placebo treated patients following 12 weeks of therapy. In a 12-week, fixed dose schizophrenia study in patients receiving with aripiprazole lauroxil, IM weight gain of 7% or greater from baseline was observed in 10% (n=207) and 9% (n=208) of patients receiving 441 mg and 882 mg IM, respectively.

During clinical trials, the percentage of pediatric and adolescent patients by indication with weight gain of 7% or more of body weight compared to placebo was (5.2% vs 1.6%), (26.3% vs 7.1%), and (20% vs 7.6%), respectively for schizophrenia/bipolar mania, irritability associated with autistic disorder, and Tourette's disorder, respectively. Treatment durations were 4 to 6 weeks, 8 weeks, and 8 to 10 weeks, respectively.[Ref]

Hypersensitivity

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:
Postmarketing reports: Allergic reaction, anaphylactic reaction, angioedema

Aripiprazole Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Hypersensitivity
Rare (0.01% to 0.1%): Drug hypersensitivity
Frequency not reported: Allergic reaction, anaphylactic reaction, angioedema

Immediate-Release IM Injection:
Frequency not reported: Allergic reaction, anaphylactic reaction, angioedema, hypersensitivity

Oral Formulations:
Uncommon (0.1% to 1%): Angioedema
Rare (0.01% to 0.1%): Hypersensitivity
Postmarketing reports: Allergic reaction, anaphylactic reaction[Ref]

Gastrointestinal

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:
Frequency not reported: Constipation, difficulty swallowing, dry mouth, dysphagia, tongue protrusion

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Abdominal discomfort, constipation, diarrhea, dry mouth, dyspepsia, nausea, toothache, vomiting
Uncommon (0.1% to 1%): Frequent bowel movement, gastroesophageal reflux disease, salivary hypersecretion, upper abdominal pain
Rare (0.01% to 0.1%): Swollen tongue
Frequency not reported: Abdominal pain, anal abscess, anorectal discomfort, aphthous stomatitis, appendicitis perforated, colitis, dental caries, difficulty swallowing, diverticulum, dysphagia, gastritis, gastroenteritis, gastroenteritis viral, gingival edema, gingival pain, gingivitis, hemorrhoids, inguinal hernia, loose tooth, oral candidiasis, pancreatitis, periodontitis, poor dental condition, tongue disorder, tongue edema, tongue protrusion, tooth abscess, tooth fracture, tooth impacted, tooth infection, tooth loss

Immediate-Release IM Injection:
Common (1% to 10%): Constipation, dyspepsia, nausea, salivary hypersecretion, vomiting
Uncommon (0.1% to 1%): Dry mouth
Frequency not reported: Abdominal discomfort, diarrhea, dysphagia, gastroesophageal reflux disease, pancreatitis, swollen tongue, stomach discomfort, tongue dry, tongue edema, tongue spasm

Oral Formulations:
Very common (10% or more): Nausea (up to 15%), vomiting (up to 14%), constipation (up to 11%)
Common (1% to 10%): Abdominal discomfort, abdominal pain upper, diarrhea, dry mouth, dyspepsia, salivary hypersecretion, stomach discomfort, toothache
Uncommon (0.1% to 1%): Dysphagia, esophagitis, gastritis, gastroesophageal reflux disease, hypoesthesia oral, swollen tongue
Rare (0.01% to 0.1%): Abdominal distention, abnormal feces, eructation, feces discolored, gastroenteritis, gastroenteritis viral, gastrointestinal disorder, gastrointestinal pain, glossitis, lip dry, mouth injury, oral candidiasis, pancreatitis, paresthesia circumoral, parotid gland enlargement, parotitis, pruritus ani, tongue discoloration
Frequency not reported: Tongue dry, tongue edema, tongue spasm[Ref]

Dermatologic

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:
Postmarketing reports: Pruritus, urticaria

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Erythema, induration/skin induration, pruritus, rash
Uncommon (0.1% to 1%): Acne, alopecia, eczema, folliculitis, fungal skin infection, rosacea
Frequency not reported: Acarodermatitis, blister, cellulitis, dry skin, excoriation, face edema, furuncle, herpes zoster, hyperhidrosis, hyperkeratosis, impetigo, lice infestation, photosensitivity reaction, pilonidal cyst, psoriasis, rash macula, skin laceration, skin lesion, skin striae, subcutaneous abscess, tinea pedis, urticaria, varicella

Immediate-Release IM Injection:
Frequency not reported: Alopecia, face edema, hirsutism, hyperhidrosis, photosensitivity reaction, pruritus, rash, urticaria

Oral Formulations:
Common (1% to 10%): Acneiform rash, allergic contact rash, drug eruption rash, erythematous rash, exfoliative rash, exfoliative seborrheic dermatitis, generalized rash, hyperhidrosis, macular rash, maculopapular rash, neurodermatitis, papular rah, rash
Uncommon (0.1% to 1%): Alopecia, face edema, photosensitivity reaction, pruritus, urticaria
Rare (0.01% to 0.1%): Body tinea, decubitus ulcer, dry skin, herpes simplex, pemphigus, psoriasis
Frequency not reported: Hirsutism[Ref]

Reports of rash included erythematous, exfoliative, generalized, macular, maculopapular, papular rash; acneiform, allergic, contact, exfoliative, seborrheic dermatitis, neurodermatitis, and drug eruption.[Ref]

Cardiovascular

Collective data from 17 placebo-controlled clinical studies involving the use of atypical antipsychotic agents in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug-treated patient than in the placebo-treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although aripiprazole (the active ingredient contained in Abilify) was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Aripiprazole is not indicated for use in the treatment of behavioral disorders in elderly patients with dementia.[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:
Frequency not reported: Angina pectoris, orthostatic hypotension, palpitations, tachycardia

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Hemorrhage, hypertension
Uncommon (0.1% to 1%): Abnormal electrocardiogram, bradycardia, chest discomfort, decreased blood pressure, electrocardiogram QT prolonged, electrocardiogram T-wave abnormal/amplitude decreased/inversion, increased blood pressure, orthostatic hypotension, peripheral edema, tachycardia, ventricular extrasystole
Rare (0.01% to 0.1%): Sinus tachycardia
Frequency not reported: Acute myocardial infarction, cardiac arrest, chest pain, congestive cardiac failure, contusion, decreased heart rate, deep vein thrombosis, first-degree atrioventricular block, orthostatic hypertension, Torsade de pointes, venous thromboembolism, ventricular arrhythmias

Immediate-Release IM Injection:
Common (1% to 10%): Tachycardia
Uncommon (0.1% to 1%): Increased diastolic blood pressure, orthostatic hypotension
Frequency not reported: Angina pectoris, atrial fibrillation, atrial flutter, atrioventricular block, bradycardia, cardiac arrest, cardiopulmonary failure, cardiorespiratory arrest, chest pain, deep vein thrombosis, electrocardiogram QT prolonged, hypertension, hypotension, myocardial infarction, myocardial ischemia, palpitations, peripheral edema, QT prolongation, Torsade de pointes, venous thromboembolism, ventricular arrhythmia

Oral Formulations:
Common (1% to 10%): Chest pain, hypertension, peripheral edema
Uncommon (0.1% to 1%): Angina pectoris, atrial fibrillation, atrioventricular block, bradycardia, cardiopulmonary failure, cardiorespiratory arrest, chest discomfort, edema, electrocardiogram QT prolonged, extrasystole, generalized edema, heart rate increased, hot flush, hypotension, myocardial infarction, myocardial ischemia, orthostatic hypotension, sinus tachycardia, tachycardia
Rare (0.01% to 0.1%): Atrial flutter, electrocardiogram abnormal, electrocardiogram PR prolongation, electrocardiogram T wave inversion, flushing, heart rate irregular, hyperemia, supraventricular tachycardia, ventricular tachycardia
Frequency not reported: Cardiac arrest, deep vein thrombosis, hypotension, palpitations, Torsade de pointes, venous thromboembolism, ventricular arrhythmias[Ref]

Hematologic

Neutropenia has been reported with the extended/prolonged-release IM injection; it typically starts around day 16 and lasts a median of 18 days.[Ref]

Aripiprazole lauroxil Extended-Release IM Suspension:
Frequency not reported: Agranulocytosis, leukopenia, neutropenia

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Neutropenia
Uncommon (0.1% to 1%): Anemia, neutrophil count decreased, thrombocytopenia, white blood cell count decreased
Frequency not reported: Agranulocytosis, bicytopenia, leukopenia, lymphadenopathy

Immediate-Release IM Injection:
Frequency not reported: Leukopenia, neutropenia, thrombocytopenia

Oral Formulations:
Uncommon (0.1% to 1%): Leukopenia, neutropenia, thrombocytopenia
Rare (0.01% to 0.1%): Eosinophil count increased, eosinophilia, lymphadenopathy, white blood cell count increased[Ref]

Endocrine

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Prolactin levels greater than 1 times the upper limit of normal
Uncommon (0.1% to 1%): Blood prolactin decreased, gynecomastia, hyperprolactinemia
Rare (0.01% to 0.1%): Hypoprolactinemia

Immediate-Release IM Injection:
Uncommon (0.1% to 1%): Hyperprolactinemia
Frequency not reported: Blood prolactin increased, gynecomastia

Oral Formulations:
Very common (10% or more): Serum prolactin levels less than 2 ng/mL (up to 53.3%), serum prolactin levels less than 3 ng/mL (up to 29.5%)
Uncommon (0.1% to 1%): Blood prolactin increased, hyperprolactinemia
Rare (0.01% to 0.1%): Early menarche, gynecomastia[Ref]

Musculoskeletal

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Increased blood creatine phosphokinase
Frequency not reported: Abnormal/prolonged muscle contractions, muscular weakness, neck muscle spasms

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Arthralgia, back pain, increased blood creatine phosphokinase, musculoskeletal pain, musculoskeletal stiffness, myalgia, pain in extremity
Uncommon (0.1% to 1%): Joint range of motion decreased, joint stiffness, muscle rigidity, muscle spasms, muscle tightness, muscle twitching, nuchal rigidity, trismus
Rare (0.01% to 0.1%): Rhabdomyolysis, thrombocytopenia
Frequency not reported: Abnormal/prolonged muscle contractions, ankle fracture, arthritis, foot fracture, joint dislocation, joint sprain, joint swelling, muscle injury, muscle strain, neck muscle spasms, radius fracture, rotator cuff syndrome, skeletal injury, stiffness

Immediate-Release IM Injection:
Frequency not reported: Increased creatine phosphokinase, mobility decreased, muscle tightness, muscular weakness, myalgia, rhabdomyolysis, stiffness

Oral Formulations:
Common (1% to 10%): Arthralgia, blood creatinine phosphokinase increased/creatine phosphokinase increase, muscle rigidity, muscle spasms, musculoskeletal stiffness, myalgia, pain in extremity
Uncommon (0.1% to 1%): mobility decreased, muscle tightness, musculoskeletal rigidity
Rare (0.01% to 0.1%): Bone pain, clavicle fracture, femoral neck fracture, flank pain, hip fracture, humerus fracture, jaw disorder, kyphosis, muscle strain, nuchal rigidity, osteoarthritis, rhabdomyolysis
Frequency not reported: Muscular weakness, stiffness[Ref]

Other

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:
Frequency not reported: Asthenia, body temperature regulation, falls

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Fatigue, inflammation, swelling
Frequency not reported: Accident, body temperature regulation, carbon monoxide poisoning, deafness, drug toxicity, ear infection, face injury, falls, fungal infection, gunshot wound, herpes virus infection, hypothermia, injury, multiple injuries, pain, procedural pain, sudden unexplained death, temperature regulation disorder, thermal burn, wound

Immediate-Release IM Injection:
Common (1% to 10%): Fatigue
Frequency not reported: Asthenia, fall, heat stroke, hypothermia, pyrexia, sudden unexplained death, temperature regulation disorder

Oral Formulations:
Very common (10% or more): Fatigue (up to 18.5%)
Common (1% to 10%): Asthenia, fall, feeling jittery, pain, pyrexia
Uncommon (0.1% to 1%): Adverse event, chills, discomfort, feeling abnormal
Rare (0.01% to 0.1%): Ear canal erythema, energy increased, facial pain, feeling cold, head lag abnormal, heat stroke, hypoacusis, hypothermia, injury, malaise, open wound, physical examination, sensation of heaviness, smoker, swelling, tenderness, tinnitus, xerosis
Frequency not reported: Sudden unexplained death, temperature regulation disorder[Ref]

In a dose response analysis, fatigue was determined to have a dose response relationship in pediatric patients with incidences of fatigue reported at 3.8%, 22%, and 18.5% in those receiving 5 mg, 10 mg, and 15 mg respectively.[Ref]

Respiratory

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:
Frequency not reported: Difficulty breathing, throat tightness
Postmarketing reports: Hiccups, laryngospasm, oropharyngeal spasm

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Bronchitis, cough, nasal congestion, nasopharyngitis, upper respiratory tract infection
Uncommon (0.1% to 1%): Hiccups, pharyngitis
Frequency not reported: Acute respiratory distress syndrome, allergic rhinitis, aspiration pneumonia, difficulty breathing, dysphonia, dyspnea, epistaxis, laryngospasm, nasal septum deviation, oropharyngeal spasm, paranasal sinus hypersecretion, pulmonary embolism, respiratory tract congestion, rhinalgia, sinus congestion, throat tightness, wheezing

Immediate-Release IM Injection:
Uncommon (0.1% to 1%): Hiccups
Frequency not reported: Aspiration pneumonia, dyspnea, laryngospasm, nasal congestion, oropharyngeal spasm, pulmonary embolism

Oral Formulations:
Common (1% to 10%): Cough, dyspnea, epistaxis, nasal congestion, nasopharyngitis, pharyngolaryngeal pain, pneumonia aspiration, upper respiratory tract infection
Uncommon (0.1% to 1%): Hiccups
Rare (0.01% to 0.1%): Dry throat, hoarseness, lower respiratory tract infection, nasal dryness, painful respiration, paranasal sinus hypersecretion, rhinorrhea, sinus congestion, sinusitis
Frequency not reported: Laryngospasm, oropharyngeal spasm pulmonary embolism[Ref]

Ocular

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Blurred vision, diplopia, eye pain, oculogyric crisis
Frequency not reported: Allergic conjunctivitis, eye irritation, eyelid ptosis, hordeolum

Immediate-Release IM Injection:
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Diplopia
Frequency not reported: Oculogyric crisis, photophobia

Oral Formulations:
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Diplopia, dry eye, eyelid edema, photophobia, photopsia
Rare (0.01% to 0.1%): Chromotopsia, conjunctivitis, eye disorder, eye movement disorder, eye redness, gaze palsy, lacrimation increased
Frequency not reported: Oculogyric crisis[Ref]

Genitourinary

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Erectile dysfunction
Uncommon (0.1% to 1%): Breast tenderness, ejaculation delayed, galactorrhea, vulvovaginal dryness
Rare (0.01% to 0.1%): Glycosuria, pollakiuria, urinary incontinence
Frequency not reported: Adnexa uteri pain, breast mass, Escherichia urinary tract infection (UTI), mastitis, micturition urgency, ovarian cyst, priapism, protein urine, suprapubic pain, urinary retention, UTIs, vaginal infections, vulvovaginal mycotic infection, white blood cells urine

Immediate-Release IM Injection:
Frequency not reported: Amenorrhea, breast pain, enuresis, erectile dysfunction, priapism, menstruation irregular, nocturia, urinary incontinence, urinary retention

Oral Formulations:
Uncommon (0.1% to 1%): Amenorrhea, breast pain, erectile dysfunction, glucose urine/glucose urine present, incontinence/urinary incontinence, menstruation irregular, nocturia, pollakiuria, polyuria, urinary retention
Rare (0.01% to 0.1%): Bladder discomfort, blood urine present, breast discharge, chromaturia, enuresis, genital pruritus female, micturition urgency, pelvic pain, priapism, proteinuria, sexual dysfunction, urethral discharge, urinary hesitation, urinary tract infection, urine ketone body present, urine output increased, vulvovaginal discomfort[Ref]

Hepatic

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Abnormal liver function test, ALT increased, AST increased, blood bilirubin increased, gamma-glutamyl transferase increased, increased hepatic enzymes
Rare (0.01% to 0.1%): Drug induced liver injury
Frequency not reported: Alkaline phosphatase increased, cholecystitis chronic, cholelithiasis, hepatic cirrhosis, hepatic failure, hepatic steatosis, hepatitis, hepatosplenomegaly, jaundice

Immediate-Release IM Injection:
Frequency not reported: Blood bilirubin increased, hepatic enzyme increased, hepatic failure, hepatitis, increased alkaline phosphatase, increased ALT, increased AST, increased gamma glutamyl transferase, jaundice

Oral Formulations:
Uncommon (0.1% to 1%): Blood bilirubin increased, hepatic enzyme increased
Rare (0.01% to 0.1%): Gamma glutamyl transferase increased, hepatitis, jaundice
Frequency not reported: Hepatic failure, increased alkaline phosphatase, increased ALT, increased AST[Ref]

Local

Aripiprazole (the active ingredient contained in Abilify) lauroxil Extended-Release IM Suspension:
Common (1% to 10%): Injection site pain
Frequency not reported: Induration, redness, swelling

Aripiprazole Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Injection site induration, injection site pain, injection site reactions
Uncommon (0.1% to 1%): Injection site discomfort, injection site erythema, injection site pruritus, injection site swelling
Frequency not reported: Infusion site hematoma, infusion site swelling, localized infection, vessel puncture site hematoma, vessel puncture site pain

Immediate-Release IM Injection:
Frequency not reported: Injection site reaction, venipuncture site bruise

Oral Formulations:
Rare (0.01% to 0.1%): Local swelling, localized infection[Ref]

Injection site reactions reported with the aripiprazole extended-release IM suspension included pain, erythema, induration, pruritus, swelling, rash, inflammation, and hemorrhage. The mean intensity of injection pain reported with the first injection was 7.1 (visual analog scale 0=no pain to 100=unbearably painful) and 4.8 with the second injection. Injection site reactions with aripiprazole lauroxil extended-release IM suspension were mostly associated with the first injection and decreased with each subsequent injection.[Ref]

Renal

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:
Uncommon (0.1% to 1%): Glycosuria, nephrolithiasis
Frequency not reported: Cystitis, glucose urine present

Immediate-Release IM Injection:
Frequency not reported: Blood creatinine increased, blood urea increased

Oral Formulations:
Uncommon (0.1% to 1%): Blood creatinine increased, blood urea increased
Rare (0.01% to 0.1%): Oliguria[Ref]

Oncologic

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:
Frequency not reported: Basal cell carcinoma, breast fibroma, pancreatic carcinoma

Oral Formulations:
Rare (0.01% to 0.1%): Cyst, oral neoplasm, skin papilloma[Ref]

Immunologic

Aripiprazole (the active ingredient contained in Abilify) Extended/Prolonged-Release IM Suspension:
Common (1% to 10%): Influenza
Frequency not reported: Influenza-like illness, viral infection

Oral Formulations:
Rare (0.01% to 0.1%): Decreased immune responsiveness[Ref]

Some side effects of Abilify may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Use is not recommended; a decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes The effects in the nursing infant are unknown.

Low levels of this drug have been detected in human milk; the maternal weight-adjusted dose calculated from 2 different women provide estimates of 0.7% and 8.3%. This drug is expected to have a minimal effect on serum prolactin levels, however 2 cases of galactorrhea have been reported.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not take aripiprazole for longer than 6 weeks unless your doctor has told you to.

Aripiprazole can be taken with or without food.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

To take the orally disintegrating tablet (Abilify Discmelt):

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.

• Use dry hands to remove the tablet and place it in your mouth.

• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

Use aripiprazole regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

You should not stop using aripiprazole suddenly. Stopping suddenly may make your condition worse.

Your doctor will need to check your progress while you are using aripiprazole.

Store at room temperature away from moisture and heat. Aripiprazole liquid may be used for up to 6 months after opening, but not after the expiration date on the medicine label.