Important warning for older adults with dementia:
Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as aripiprazole have an increased chance of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or ministroke or other severe side effects during treatment.
Aripiprazole is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking aripiprazole. For more information visit the FDA website: http://www.fda.gov/Drugs.
Important warning for people who have depression:
A small number of children, teenagers, and young adults (up to 24 years of age) who took medications for depression during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take aripiprazole to treat depression, but in some cases, a doctor may decide that aripiprazole is the best medication to treat a child's condition.
You should know that your mental health may change in unexpected ways when you take aripiprazole or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and mania (frenzied, abnormally excited mood). Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
Your healthcare provider will want to see you often while you are taking aripiprazole, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.
The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with aripiprazole. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.
No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.
Aripiprazole is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used alone or with other medications to treat episodes of mania or mixed episodes (symptoms of mania and depression that happen together) in adults, teenagers, and children 10 years of age and older with bipolar disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Aripiprazole is also used with an antidepressant to treat depression when symptoms cannot be controlled by the antidepressant alone. Aripiprazole is also used to treat children 6 to 17 years of age who have autistic disorder (a developmental problem that causes difficulty communicating and interacting with others). Aripiprazole may help control irritable behavior such as aggression, temper tantrums, and frequent mood changes in these children. Aripiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Aripiprazole comes as a tablet, a solution (liquid), and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. It is usually taken once a day with or without food. Take aripiprazole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take aripiprazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Do not try to push the orally disintegrating tablet through the foil. Instead, use dry hands to peel back the foil packaging. Immediately take out the tablet and place the entire tablet on your tongue. Do not try to split the tablet. The tablet will quickly dissolve and can be swallowed without liquid. If necessary, liquid can be used to take the orally disintegrating tablet.
Your doctor may start you on a low dose of aripiprazole and gradually increase or decrease your dose depending on how well the medication works for you and the side effects you experience.
Aripiprazole may help control your symptoms, but will not cure your condition. It may take 2 weeks or longer before you feel the full benefit of aripiprazole. Continue to take aripiprazole even if you feel well. Do not stop taking aripiprazole without talking to your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Talk to your doctor about drinking grapefruit juice while taking this medicine.
Be sure to drink plenty of water every day while you are taking this medication.
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.
pain, especially in the arms, legs, or joints
slow, fast, or irregular heartbeat
changes in vision
unusual movements of your body or face that you cannot control
swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
tightening of the neck muscles
tightness in the throat
Aripiprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets, the solution, and the orally disintegrating tablets at room temperature and away from excess heat and moisture (not in the bathroom). Always store the orally disintegrating tablets in their sealed package, and use them immediately after opening the package. Throw away any medication that is outdated or no longer needed. Throw away any unused aripiprazole solution 6 months after you open the bottle or when the expiration date marked on the bottle has passed, whichever is sooner. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
widened pupils (black circles in the middle of the eyes)
changes in heartbeat
movements that you cannot control
loss of consciousness
Keep all appointments with your doctor and the laboratory. Your doctor may order laboratory tests before and during your treatment with aripiprazole.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 05/16/2011
AHFS® Consumer Medication Information. © Copyright, 2015. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.