Prescription medicine
Aripiprazole lauroxil Brand names: Aristada
Aripiprazole lauroxil (Aristada) is a prescription medicine with an FDA approval on record since 2015. No generic is listed; pharmacies paid $993.60 per mL (Aristada ER 1,064 mg/3.9 mL syringe) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the aripiprazole lauroxil FDA label on DailyMed (effective January 28, 2025, Alkermes, Inc.); the NDA 207533 record on Drugs@FDA; every aripiprazole lauroxil label on DailyMed.
Highlights of the record
FDA label of January 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ( 5.1 ) ARISTADA is not approved for the treatment of patients with dementia-related psychosis.
Used for
From the label: indications and usageARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14 )].
Forms and strengths
- 441 mg/1.6ml
- 662 mg/2.4ml
- 675 mg/2.4ml
- 882 mg/3.2ml
- 1064 mg/3.9ml
Extended-release injection (suspension).
On the market
- Earliest approval on file
- October 5, 2015 Aristada, Alkermes Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 6, 2039 Aristada injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $993.60 per mL Aristada ER 1,064 mg/3.9 mL syringe
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,532 through July 30, 2026
What is aripiprazole lauroxil used for?
From the label: indications and usageARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14 )]. ARISTADA is an atypical antipsychotic indicated for the treatment of schizophrenia in adults ( 1 ).
Conditions named in the indications of aripiprazole lauroxil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (ARISTADA), Alkermes, Inc., effective January 28, 2025 (SPL set 17a8d11b-73b0-4833-a0b4-cf1ef85edefb), via openFDA; the full label on DailyMed
What does the patient leaflet for aripiprazole lauroxil say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ARISTADA?Each injection of ARISTADA must be administered by a healthcare professional only. ARISTADA may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. ARISTADA increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ARISTADA is not for the treatment of people with dementia-related psychosis.
From the patient leaflet: What should I avoid while receiving ARISTADA?Do not drive a car, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA affects you. ARISTADA may affect your judgment, thinking or motor skills. Avoid becoming too hot or dehydrated while you receive ARISTADA. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
Source: FDA drug label (ARISTADA), Alkermes, Inc., effective January 28, 2025 (SPL set 17a8d11b-73b0-4833-a0b4-cf1ef85edefb), via openFDA; the full label on DailyMed
Is there a generic for aripiprazole lauroxil (Aristada)?
No generic aripiprazole lauroxil is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 18 patents for Aristada injection: the compound patent runs to October 26, 2030, and the last listed entry to April 6, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for aripiprazole lauroxil (Aristada)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $993.60 per mL (Aristada ER 1,064 mg/3.9 mL syringe), up 6% from $933.31 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Aristada ER 1,064 mg/3.9 mL syringe (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Aristada ER 1,064 mg/3.9 mL syringe | Brand | $993.60 per mL | n/a | +6% |
| Aristada ER 441 mg/1.6 mL syrn | Brand | $1,007.59 per mL | n/a | +7% |
| Aristada ER 662 mg/2.4 mL syrn | Brand | $1,006.57 per mL | n/a | +7% |
| Aristada ER 882 mg/3.2 mL syrn | Brand | $1,004.18 per mL | n/a | +6% |
| Aristada initio ER 675 mg/2.4 | Brand | $1,026.91 per mL | n/a | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the aripiprazole lauroxil label say about other medicines?
The aripiprazole lauroxil label names 23 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aripiprazole | contraindications | CONTRAINDICATIONS ARISTADA is contraindicated in patients with a known hypersensitivity reaction to aripiprazole. |
| Carbamazepine | drug interactions | Strong CYP3A4 Inducers Clinical Impact: The concomitant use of oral aripiprazole and carbamazepine decreased the exposure of aripiprazole compared to the use of oral aripiprazole alone. Intervention: With concomitant use of ARISTADA with a strong CYP3A4 inducer for more than 2 weeks consider increasing the ARISTADA dose [see Dosage and Administration ()]. Examples: carbamazepine, rifampin |
| Carvedilol | drug interactions | Clinical Impact: Due to its alpha adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents. Intervention: Monitor blood pressure and adjust dose accordingly [see Warnings and Precautions ( 5.8 )]. Examples: carvedilol, lisinopril, prazosin Benzodiazepines |
| Clarithromycin | drug interactions | Strong CYP3A4 Inhibitors and CYP2D6 Inhibitors Clinical Impact: The concomitant use of oral aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of oral aripiprazole alone. … ARISTADA dose [see Dosage and Administration ()]. Examples: itraconazole, clarithromycin, quinidine, fluoxetine, paroxetine |
| Dextromethorphan | drug interactions | In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin, escitalopram), or CYP3A4 (e.g., dextromethorphan) when co-administered with ARISTADA. |
| Escitalopram | drug interactions | In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin, escitalopram), or CYP3A4 (e.g., dextromethorphan) when co-administered with ARISTADA. |
| Famotidine | drug interactions | Interactions with ARISTADA Based on pharmacokinetic studies with oral aripiprazole, no dosage adjustment of ARISTADA is required when administered concomitantly with famotidine, valproate, or lithium [see Clinical Pharmacology ( 12.3 )]. |
| Fluoxetine | drug interactions | Strong CYP3A4 Inhibitors and CYP2D6 Inhibitors Clinical Impact: The concomitant use of oral aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of oral aripiprazole alone. … and Administration ()]. Examples: itraconazole, clarithromycin, quinidine, fluoxetine, paroxetine |
| Itraconazole | drug interactions | Strong CYP3A4 Inhibitors and CYP2D6 Inhibitors Clinical Impact: The concomitant use of oral aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of oral aripiprazole alone. … weeks, reduce the ARISTADA dose [see Dosage and Administration ()]. Examples: itraconazole, clarithromycin, quinidine, fluoxetine, paroxetine |
| Lamotrigine | drug interactions | Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, or sertraline when co-administered with ARISTADA [see Clinical Pharmacology ( 12.3 )]. |
| Lisinopril | drug interactions | Clinical Impact: Due to its alpha adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents. Intervention: Monitor blood pressure and adjust dose accordingly [see Warnings and Precautions ( 5.8 )]. Examples: carvedilol, lisinopril, prazosin Benzodiazepines |
| Lithium | drug interactions | Interactions with ARISTADA Based on pharmacokinetic studies with oral aripiprazole, no dosage adjustment of ARISTADA is required when administered concomitantly with famotidine, valproate, or lithium [see Clinical Pharmacology ( 12.3 )]. |
| Lorazepam | drug interactions | Benzodiazepines Clinical Impact: The intensity of sedation was greater with the combination of oral aripiprazole and lorazepam as compared to that observed with aripiprazole alone. … Intervention: Monitor sedation and blood pressure. Adjust dose accordingly. Example: lorazepam |
| Olanzapine | warnings and precautions | In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly patients with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated patients. |
Every other medicine the aripiprazole lauroxil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Omeprazole | drug interactions | … paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin, escitalopram), or CYP3A4 (e.g., dextromethorphan) when co-administered with ARISTADA. |
| Paroxetine | drug interactions | Strong CYP3A4 Inhibitors and CYP2D6 Inhibitors Clinical Impact: The concomitant use of oral aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of oral aripiprazole alone. … Administration ()]. Examples: itraconazole, clarithromycin, quinidine, fluoxetine, paroxetine |
| Prazosin | drug interactions | Clinical Impact: Due to its alpha adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents. Intervention: Monitor blood pressure and adjust dose accordingly [see Warnings and Precautions ( 5.8 )]. Examples: carvedilol, lisinopril, prazosin Benzodiazepines |
| Quinidine | drug interactions | Strong CYP3A4 Inhibitors and CYP2D6 Inhibitors Clinical Impact: The concomitant use of oral aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of oral aripiprazole alone. … [see Dosage and Administration ()]. Examples: itraconazole, clarithromycin, quinidine, fluoxetine, paroxetine |
| Rifampin | drug interactions | Strong CYP3A4 Inducers Clinical Impact: The concomitant use of oral aripiprazole and carbamazepine decreased the exposure of aripiprazole compared to the use of oral aripiprazole alone. Intervention: With concomitant use of ARISTADA with a strong CYP3A4 inducer for more than 2 weeks consider increasing the ARISTADA dose [see Dosage and Administration ()]. Examples: carbamazepine, rifampin |
| Risperidone | warnings and precautions | In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly patients with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular … |
| Sertraline | drug interactions | Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, or sertraline when co-administered with ARISTADA [see Clinical Pharmacology ( 12.3 )]. |
| Venlafaxine | drug interactions | In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin … |
| Warfarin | drug interactions | In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin … |
Source: FDA drug label (ARISTADA), Alkermes, Inc., effective January 28, 2025 (SPL set 17a8d11b-73b0-4833-a0b4-cf1ef85edefb), via openFDA; the full label on DailyMed
What do FAERS reports show for aripiprazole lauroxil?
The FDA Adverse Event Reporting System holds 4,532 reports that list aripiprazole lauroxil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 81 are coded as a death and 523 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as aripiprazole lauroxil?
7 other medicines are given the same way (intramuscular) and in the same FDA class as aripiprazole lauroxil or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intramuscular) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Olanzapine | Schizophrenia | 12 labelers | $20.92 per vial 10 mg vial | No current entry |
| Paliperidone | Schizophrenia | none listed | $2,337.05 per mL 78 mg/0.5 mL | No current entry |
| Ziprasidone | Schizophrenia | 8 labelers | $21.81 per vial 20 mg/mL vial | No current entry |
| Risperidone | Schizophrenia | 1 labeler | $355.23 per vial 25 mg vial | No current entry |
| Aripiprazole | Schizophrenia | none listed | $1,782.93 per mL 960 mg/3.2 mL | No current entry |
| Haloperidol | Schizophrenia | 18 labelers | $15.60 per mL 100 mg/mL vial | A presentation being discontinued |
| Chlorpromazine | Schizophrenia | 13 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as aripiprazole lauroxil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to aripiprazole lauroxil
- 7 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Aripiprazole lauroxil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other