Aripiprazole

Abilify is the brand name of the drug aripiprazole, which is used to treat psychotic conditions, such as schizophrenia and bipolar disorder.

It may also be used to treat major depression in adults and agitation in children with autism.

Abilify is in a class of medications known as atypical antipsychotics. It works by changing the activity of dopamine, one of the neurotransmitters in your brain.

The medication was approved by the Food and Drug Administration (FDA) in 2002.

Abilify Warnings

The FDA requires that Abilify carry a black-box warning about the risks associated with the drug’s use among people with dementia.

Studies show that older adults with dementia who take antipsychotic medicines such as Abilify may be at an increased risk for death.

They may also be at a greater risk for suffering a stroke, transient ischemic attack (TIA, or mini-stroke), or other severe side effects.

The FDA has not approved Abilify for use in adults with dementia.

Additionally, some people taking Abilify have exhibited unusually reckless or compulsive behaviors, such as compulsive gambling, sexual activity, binge eating, or compulsive shopping. 

Children, teenagers, and young adults (up to age 24) who took Abilify for depression were more likely to become suicidal.

Children under 18 years old shouldn’t take Abilify to treat depression, but in some cases, a doctor may decide this medication is the best option for a child.

Abilify may affect your mental health in unexpected ways, even if you are older than 24. You may become suicidal, especially at the start of treatment.

You or a caregiver should call your doctor right away if you experience any of the following symptoms:

• Thoughts of suicide or harming yourself
• New or worsening depression
• Panic attacks
• Extreme worry
• Agitation
• Aggressive behavior
• Difficulty falling asleep or staying asleep
• Acting without thinking
• Severe restlessness
• Mania (feeling frenzied or abnormally excited)

You may experience increases in your blood sugar while taking Abilify and may be at an increased risk for developing diabetes. Tell your doctor if you or anyone in your family has ever had diabetes.

Also, watch for any signs of high blood sugar, such as increased thirst or urination, excessive hunger, or weakness.

You should avoid becoming overheated or dehydrated while taking this medicine. Abilify may make it harder for your body to cool down when you are hot.

Drink plenty of fluids, too, especially during hot weather or when you are engaging in vigorous activity.

Before taking Abilify, you should tell your doctor if you have ever had:

• Heart disease, heart failure, a heart attack, or an irregular heartbeat
• Low or high blood pressure
• A stroke or TIA
• Seizures
• Breast cancer
• High cholesterol
• Low white blood cell counts
• Liver or kidney disease
• Any condition that makes it difficult to swallow

It may take two weeks or longer until you feel the benefits of Abilify. You should not stop taking it without first talking to your doctor.

You should tell your doctor you are taking Abilify before undergoing any type of surgery, including dental procedures.

Before taking Abilify, alert your physician if you have ever used street drugs or abused prescription medicines.

Pregnancy and Abilify

Abilify may cause harm to an unborn baby.

Tell your doctor if you are pregnant or plan to become pregnant before you take Abilify.

Taking this medicine during the last months of pregnancy can cause problems in newborns after delivery.

You should also talk to your doctor before breastfeeding while taking Abilify.

The drug has been detected in breast milk, but there’s little information on the risks Abilify might present to a breastfeeding infant.

You should always tell your doctor about any prescription, non-prescription, illegal, and recreational drugs; herbal remedies; and nutritional and dietary supplements you’re taking, especially:

• Antidepressants
• Medications for anxiety, high blood pressure, irritable bowel syndrome, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
• Antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Antihistamines, such as chlorpheniramine (Chlor-Trimeton) and diphenhydramine (Benadryl)
• 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)
• Nefazodone (Serzone)
• Paroxetine (Paxil, Pexeva)
• Quinidine
• Rifampin (Rifadin, Rimactane)
• Sedatives
• Sleeping pills
• Telithromycin (Ketek)
• Tranquilizers

Abilify and Alcohol

Abilify may make you drowsy, and consuming alcohol while taking it can make you even drowsier.

You should not drink alcohol while taking this medication.

Abilify and Grapefruit

You should talk to your doctor before consuming grapefruit or grapefruit juice while taking this medication.

It may cause an interaction that could cause high levels of Abilify to accumulate in your body..

Abilify and Other Interactions

Abilify may make you drowsy.

Don't drive, operate machinery, or perform any activity that requires alertness until you are certain you can do so safely.

Abilify, Abilify Maintena, and Aristrada are the brand names available for apriprazole in the US.

Oral and Immediate-Release Injectable:

Aripiprazole is a prescription medication used to treat:

• schizophrenia in people age 13 years and older
• bipolar I disorder in people age 10 years and older, including:
  • manic or mixed episodes that happen with bipolar I disorder
  • manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate
  • long-term treatment of bipolar I disorder
• major depression in adults, as an add-on treatment to an antidepressant medicine when you do not get better with an antidepressant alone
• irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old
• agitation associated with schizophrenia or bipolar disorder

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Extended-Release Injectable:

• Aripiprazole extended-release injectable is a prescription medication used to treat schizophrenia and is also used for acute schizophrenia relapse in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Aripiprazole has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from aripiprazole, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

If you take too much aripiprazole call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If aripiprazole is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

• Store aripiprazole at room temperature.
• Opened bottles of aripiprazole oral solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.
• Keep aripiprazole and all medicines out of the reach of children.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For aripiprazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to aripiprazole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole in children younger than 13 years of age with schizophrenia and in children younger than 10 years of age with bipolar disorder. Safety and efficacy have not been established.

Aripiprazole is not approved for use in children or teenagers with major depression.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of aripiprazole in children 6 to 17 years of age with autistic disorder.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aripiprazole in elderly patients who have schizophrenia, depression, or bipolar disorder. aripiprazole should not be used to treat behavioral problems in elderly patients who have dementia or Alzheimer disease.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking aripiprazole, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using aripiprazole with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Fluconazole
• Mesoridazine
• Metoclopramide
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using aripiprazole with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Alfuzosin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apomorphine
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Boceprevir
• Bromazepam
• Buprenorphine
• Bupropion
• Buserelin
• Butorphanol
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Ebastine
• Efavirenz
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fentanyl
• Fingolimod
• Flecainide
• Flibanserin
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Itraconazole
• Ivabradine
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Levorphanol
• Lopinavir
• Lumefantrine
• Mefloquine
• Meperidine
• Methadone
• Metronidazole
• Mifepristone
• Milnacipran
• Mitotane
• Mizolastine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nelfinavir
• Netupitant
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Oxycodone
• Oxymorphone
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Periciazine
• Perphenazine
• Phenytoin
• Pimavanserin
• Pipamperone
• Pitolisant
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Remifentanil
• Ribociclib
• Rifampin
• Rilpivirine
• Risperidone
• Ritonavir
• Sertindole
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sufentanil
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tizanidine
• Tolterodine
• Toremifene
• Tramadol
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using aripiprazole with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use aripiprazole, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of aripiprazole. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Depression or
• Diabetes, or family history of or
• Drug abuse or dependence, history of or
• Hyperglycemia (high blood sugar) or
• Neuroleptic malignant syndrome (NMS), history of or
• Neutropenia (low white blood cells) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Blood vessel disease or
• Dehydration or
• Heart attack or stroke, history of or
• Heart disease or
• Heart failure or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Hypovolemia (decrease in blood volume) or
• Ischemic heart disease, history of or
• Trouble with swallowing—Use with caution. May cause side effects to become worse.

• Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to make sure aripiprazole is working properly. Blood and urine tests may be needed to check for any unwanted effects.

For some patients, aripiprazole can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.

aripiprazole may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking aripiprazole.

Aripiprazole may cause drowsiness, trouble with thinking, or trouble with controlling movements, which may lead to falls, fractures or other injuries. Make sure you know how you react to aripiprazole before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think well.

Check with your doctor right away if you have any of the following symptoms while using aripiprazole: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

aripiprazole may cause tardive dyskinesia (a movement disorder) especially in elderly women. Check with your doctor right away if you have any of the following symptoms while taking aripiprazole: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Some people who have used aripiprazole had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using aripiprazole.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

aripiprazole may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

aripiprazole may increase the amount of sugar in your blood. Also, the oral liquid form contains sugar. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

aripiprazole can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

aripiprazole may increase your weight. Your doctor may need to check your weight on a regular basis while you are using aripiprazole.

Do not change the dose or stop taking aripiprazole without checking first with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

In patients ≥65 years of age who were administered a single oral dose, clearance was 20% lower than that observed in younger patients.

No dosage adjustment necessary.

No dosage adjustment necessary.

Some products may contain phenylalanine.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of aripiprazole.

Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking aripiprazole.