What is ARIPIPRAZOLE LAUROXIL used for?

ARIPIPRAZOLE LAUROXIL is used to treat schizophrenia in adults.

Can ARISTADA be used for dementia-related psychosis?

No, ARISTADA is not approved for the treatment of patients with dementia-related psychosis.

How is ARIPIPRAZOLE LAUROXIL administered?

It is given as an injection into a muscle by a healthcare professional.

What are the most common side effects of ARISTADA?

The most common side effect is akathisia, which is a feeling of inner restlessness.

Can I take ARISTADA if I am pregnant?

There is a pregnancy exposure registry to monitor outcomes, as babies exposed in the third trimester may have symptoms after birth.

Does ARIPIPRAZOLE LAUROXIL cause weight gain?

Yes, the medication can cause metabolic changes including weight gain and high blood sugar.

Is ARISTADA safe for elderly patients?

Safety in patients over 65 has not been evaluated, and it carries a risk of death for elderly patients with dementia-related psychosis.

What should I do if I have a reaction to ARISTADA?

You can report suspected adverse reactions to the manufacturer at 1-866-274-7823 or to the FDA.

aripiprazole lauroxil | CAS 1259305-29-7 | DDINXHAORAAYAD

Loading compound...

Atypical antipsychotic

How it worksARIPIPRAZOLE LAUROXIL is a prodrug that turns into aripiprazole in the body. It works by acting as a partial helper for dopamine D2 and serotonin 1a receptors and a blocker for serotonin 2a receptors.

Brand names:ARISTADA INITIO KIT, ARISTADA

Used for

Schizophrenia in adults

Conditions

Schizophrenia

Class

AntipsychoticAtypical AntipsychoticAtypical antipsychoticCentral Nervous System

How to take

FormsExtended-release injectable suspension

RoutesIntramuscular injection

This medication must be given as an injection into a muscle (deltoid or gluteal) by a healthcare professional. Before starting ARISTADA, patients who have never taken oral aripiprazole must first establish tolerability with the oral version.

Dose adjustments may be needed for people who are poor metabolizers of certain enzymes (CYP2D6) or those taking specific other medications.

Missed dose: Dosing regimen adjustments may be required for missed doses.

Key warnings

ARIPIPRAZOLE LAUROXIL increases the risk of death in elderly patients with dementia-related psychosis. It is not approved to treat dementia-related psychosis.

·ARIPIPRAZOLE LAUROXIL increases the risk of death in elderly patients with dementia-related psychosis. It is not approved to treat dementia-related psychosis.
·Increased risk of stroke or death in elderly patients with dementia-related psychosis.
·Risk of Neuroleptic Malignant Syndrome (a life-threatening reaction).
·Risk of Tardive Dyskinesia (permanent movement disorders).
·Potential for compulsive behaviors such as pathological gambling.
·Risk of metabolic changes like weight gain and high blood sugar.

Do not use if

·People with a known allergy or hypersensitivity to aripiprazole should not use this medication.

Side effects

Common

Akathisia (a feeling of restlessness)Weight gainChanges in blood sugarChanges in cholesterolTremorsVomitingSleepiness

Serious

·Stroke or other brain blood vessel issues
·Neuroleptic Malignant Syndrome
·Tardive Dyskinesia (uncontrollable movements)
·Seizures
·Abnormal white blood cell counts
·Compulsive behaviors like gambling
·High blood sugar
·Low blood pressure when standing up

Seek help if

·Signs of Neuroleptic Malignant Syndrome
·Signs of Tardive Dyskinesia
·Signs of allergic reaction (anaphylaxis)
·Signs of stroke

Interactions

·Strong CYP3A4 inhibitors (like itraconazole or clarithromycin) can increase drug levels.
·Strong CYP3A4 inducers (like carbamazepine or rifampin) can decrease drug levels.
·Antihypertensive drugs may interact due to blood pressure effects.
·Other antipsychotics like Seroquel, Vraylar, and Uzedy are noted in interaction data.

Special populations

PregnancyBabies exposed to this drug during the third trimester of pregnancy may experience withdrawal symptoms or movement issues after birth. There is not enough data to confirm specific risks for birth defects or miscarriage.

PediatricThe safety and effectiveness of ARIPIPRAZOLE LAUROXIL in children and teenagers have not been tested.

GeriatricSafety in adults over 65 has not been evaluated. This drug should not be used to treat dementia-related psychosis due to an increased risk of death in that group.

Talk to your doctor

Monitor

·Weight
·Blood sugar (hyperglycemia)
·Blood lipids (dyslipidemia)
·White blood cell count
·Blood pressure and heart rate

Questions to ask

·Should I take oral aripiprazole before starting ARISTADA?
·How will this affect my blood sugar or cholesterol?
·Are there specific drug interactions I should know about?
·What are the risks if I have a history of seizures?

Pharmacokinetics

OnsetAppearance of aripiprazole in circulation starts from 5 to 6 days after injection.

DurationReleased for an additional 36 days following injection.

MetabolismAripiprazole lauroxil is a prodrug converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, then to aripiprazole.

Practical

OverdoseSymptoms of an overdose may include vomiting, sleepiness, tremors, confusion, convulsions, or a depressed level of consciousness.

StorageStore at room temperature between 20°C to 25°C (68°F to 77°F).

Ingredients

Inactive

sorbitan monolauratepolysorbate 20sodium chloridesodium phosphate dibasic anhydroussodium phosphate monobasic dihydratewater for injection

Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-25.