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Overview: Aristada is used to treat schizophrenia. It is a long-acting injection given into a muscle. The most common side effect is restlessness. Aristada can affect your alertness or coordination. It can also affect your body’s ability to regulate temperature. Try to avoid getting overheated, stay hydrated, and wear light and breathable clothing while you are using Aristada.

Uses

What is Aristada used for?

Aristada (aripiprazole) is commonly used to treat schizophrenia, which is a mental health condition.

Aristada may also be used for other conditions as determined by your healthcare provider.

See also: Abilify Asimtufii, Abilify Maintena, Aripiprazole, and Opipza

How does Aristada work (mechanism of action)?

Aristada belongs to a group of medicines called second-generation (atypical) antipsychotics. It is thought to work by balancing brain chemicals called serotonin and dopamine. These chemicals are known to affect thoughts and mood.

How is Aristada supplied (dosage forms)?

Brands and other names

  • Aristada
  • Aristada Initio

Dosage forms and strengths

Aristada or Aristada Initio are available in an injectable form that is given by a healthcare provider.

How should I store Aristada?

Aristada is usually given by a healthcare provider in a hospital, clinic, or pharmacy. You will not store it at home.

Side Effects

What are the most common side effects of Aristada?

The most common side effect of Aristada is restlessness (akathisia). Tell your healthcare provider if you have restlessness that bothers you.

There may be other side effects of Aristada that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Aristada?

While less common, the most serious side effects of Aristada are described below, along with what to do if they happen.

Severe Allergic Reactions. Aristada may cause allergic reactions, which can be serious. Stop using Aristada and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Neuroleptic Malignant Syndrome (NMS). Antipsychotic medicines, like Aristada, may cause a rare but serious condition called neuroleptic malignant syndrome. NMS can lead to death. Stop using Aristada and contact your healthcare provider right away if you have any of the following symptoms.

  • High fever
  • Muscle stiffness or rigidity, where it is hard to move
  • Confusion 
  • Changes in your breathing or heart rate
  • Increased sweating

Uncontrolled Movements. Aristada can cause some people to have movements that they cannot control. This condition, called tardive dyskinesia (TD), can cause jerky movements of the face, tongue, or body. TD can be permanent. Call your healthcare provider right away if you have any of the following symptoms of TD.

  • Tongue sticking out
  • Lip smacking or puckering
  • Grimacing
  • Rapid eye blinking
  • Jerking or twisting motion of the arms, legs, or trunk

Metabolism Problems. Aristada can cause high blood sugar levels or diabetes, high cholesterol levels, and weight gain. Keep all appointments with your healthcare provider to check your blood work and weight. Call your healthcare provider if you gain weight or develop the following symptoms of high blood sugar.

  • Thirsty more than usual
  • Peeing more than usual
  • Increase in hunger
  • Tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Unusual or Compulsive Behaviors. Aristada can cause some people to have strong unusual and uncontrolled urges (compulsions), including gambling, sex, shopping, or eating. Talk to your healthcare provider right away if you or someone you know notices that you have new or worsening strong urges or behaviors.

Low Blood Pressure Upon Standing (Orthostatic Hypotension) and Falls. Aristada may cause a sudden drop in blood pressure when standing up from a seated or lying position. This may increase your risk of falling. To help prevent this, be careful not to get up too quickly. If you feel dizzy, sit or lie down right away until the dizziness stops, then take your time getting up again. Tell your healthcare provider right away if you have any of the following symptoms of orthostatic hypotension.

  • Dizziness, feeling lightheaded, or fainting upon standing
  • Blurred vision
  • Confusion
  • Feeling weak

Blood Disorders. Aristada can cause blood disorders, such as low white blood cell levels (leukopenia, neutropenia, or agranulocytosis). Keep all appointments with your healthcare provider to check your blood work. Stop using Aristada and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Decreased Alertness or Coordination. Aristada can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Aristada affects you.

Seizures. Some people who have used Aristada have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Stop using Aristada and call your healthcare provider if you have any of the following signs that a seizure is happening or could happen.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness

Body Temperature Regulation. Aristada can affect your ability to regulate your body temperature. This could make you become very hot, especially in hot weather or after exercising a lot. You should drink water and avoid overheating and dehydration. Call your healthcare provider right away if you are severely ill and have the following symptoms.

  • Excessive or no sweating
  • Dry mouth
  • Feeling very hot
  • Feeling thirsty
  • Not able to pee

Trouble Swallowing. Aristada can cause trouble swallowing (dysphagia), which can increase your risk of choking while eating or drinking. Eat small amounts of food, and chew your food well. Get emergency help if you are choking or have food stuck in your esophagus that is not passing.

Warnings & Precautions

Who should not use Aristada?

Allergies to Ingredients. People who are allergic to any of the following should not use Aristada.

  • Aristada
  • Aristada Initio
  • Aripiprazole
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Aristada.

What should I know about Aristada before using it?

Aristada is given to you by a healthcare provider in a hospital, clinic, or pharmacy. It is given as an injection in your arm or butt muscle. 

You should have taken aripiprazole (the medicine in Aristada) by mouth before starting Aristada to make sure you tolerate the medicine. Depending on your treatment plan, your healthcare provider may start you with a one-time dose of Aristada Initio or with Aristada. Follow your healthcare provider’s instructions for how to use Aristada.

Because Aristada can make it hard for you to regulate your body temperature, try to avoid becoming too hot or dehydrated. Drink plenty of water, limit your exposure to the heat and sun, do not overexercise, and wear light and breathable clothing.

People who are 65 or older can be at greater risk for some side effects from Aristada. Talk to your healthcare provider about your risks if you are in this age group.

What should I tell my healthcare provider before using Aristada?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Aristada is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have or have had any of the following.

Psychosis Related to Dementia. There is a higher risk of death, stroke, or ministroke in older adults who use Aristada or another antipsychotic and have memory loss or psychosis related to dementia. Aristada is not approved to treat dementia-related psychosis.

Injection Site. Tell your healthcare provider if you have any problems with your arm or butt muscle that may affect your ability to receive the Aristada injection.

Other Medicines and Supplements. Aristada may interact with other medicines and supplements. Before using Aristada, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Aristada used later in pregnancy may lead to an increased risk of certain problems in your newborn. Tell your healthcare provider if you are or plan to become pregnant while using Aristada. Your healthcare provider will advise you if you should use Aristada while you are pregnant or trying to get pregnant. If you become pregnant while using Aristada, you can register with the National Pregnancy Registry for Psychiatric Medications by calling 866-961-2388 or at womensmentalhealth.org/research/pregnancyregistry. This registry collects safety information about the use of psychiatric medicines during pregnancy.

Breastfeeding. Aristada passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Aristada while breastfeeding.

How can I get more information about Aristada?

For more information about Aristada, you can visit the manufacturer’s website at www.aristada.com or call them at 866-274-7823.

Interactions

Does Aristada interact with foods or drinks?

There are no known interactions between Aristada and foods or drinks.

It is unknown if drinking alcohol will affect Aristada. Drinking alcohol while using Aristada could increase your risk of sleepiness, dizziness, feeling lightheaded, or fainting upon standing. 

Does Aristada interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Aristada.

  • Ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), or voriconazole (Vfend), which is a medicine used for fungal infections
  • Paroxetine or fluoxetine, which is a medicine commonly used for anxiety and depression
  • Carbamazepine (Tegretol, Carbatrol, and others) or phenytoin (Dilantin, Phenytek, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Clarithromycin, which is a medicine used for bacterial infections
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • A benzodiazepine, such as lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures
  • A medicine for high blood pressure
  • Quinidine, which is a medicine used to treat heart rhythm problems
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, and medicines for anxiety

Many other medicines may alter the blood levels of Aristada. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Aristada. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Aristada?

If you or someone else has used too much Aristada, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Aristada?

If you miss an appointment to get your Aristada dose, call to make another appointment as soon as possible. 

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