What the FDA labels say about taking them together
Aripiprazole and aripiprazole lauroxil
Aripiprazole lauroxil's FDA label of January 28, 2025 names aripiprazole in its contraindications section; aripiprazole's label does not name aripiprazole lauroxil itself but warns about its class (Atypical antipsychotics). The aripiprazole lauroxil label: “Concomitant use of oral aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of oral aripiprazole alone.”
Check it at the source: the aripiprazole FDA label on DailyMed (effective January 29, 2025, Otsuka America Pharmaceutical, Inc.); the aripiprazole lauroxil FDA label on DailyMed (effective January 28, 2025, Alkermes, Inc.).
What does the aripiprazole label say about aripiprazole lauroxil?
Aripiprazole's label does not name aripiprazole lauroxil itself; it warns about its class (Atypical antipsychotics):
Aripiprazole label, boxed warningINCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Aripiprazole label, boxed warningElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Source: FDA drug label (ABILIFY), Otsuka America Pharmaceutical, Inc., effective January 29, 2025 (SPL set c040bd1d-45b7-49f2-93ea-aed7220b30ac), via openFDA; the full label on DailyMed
What does the aripiprazole lauroxil label say about aripiprazole?
Aripiprazole lauroxil label, contraindicationsCONTRAINDICATIONS ARISTADA is contraindicated in patients with a known hypersensitivity reaction to aripiprazole.
Aripiprazole lauroxil label, drug interactionsStrong 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. Intervention: With concomitant use of ARISTADA with a strong CYP3A4 inhibitor or CYP2D6 inhibitor for more than 2 weeks, reduce the ARISTADA dose [see Dosage and Administration ()]. Examples: itraconazole, clarithromycin, quinidine, fluoxetine, paroxetine
Aripiprazole lauroxil label, warnings and precautionsProportion of Adult Patients with Shifts in Weight in the 12-Week, Placebo-Controlled, Fixed-Dose Schizophrenia Trial Placebo N = 207 (%) ARISTADA 441 mg N = 207 (%) 882 mg N = 208 (%) Weight Gain ≥7% increase from baseline 6 10 9 5.7 Pathological Gambling and Other Compulsive Behaviors Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole.
Aristada Initio label (Alkermes, Inc., January 28, 2025), drug interactionsStrong CYP3A4 Inhibitors and CYP2D6 Inhibitors Clinical Impact: Concomitant use of oral aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of oral aripiprazole alone. Intervention: Avoid concomitant use of ARISTADA INITIO with strong CYP3A4 or strong CYP2D6 inhibitors because the dosage of ARISTADA INITIO cannot be modified [see Dosage and Administration ()]. Examples: itraconazole, clarithromycin, quinidine, fluoxetine, paroxetine
Aristada Initio label (Alkermes, Inc., January 28, 2025), warnings and precautionsGambling and Other Compulsive Behaviors Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole.
Source: FDA drug label (Aristada Initio, NDA209830), Alkermes, Inc., effective January 28, 2025 (SPL set b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403), via openFDA
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
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Aripiprazole | Aripiprazole lauroxil | |
|---|---|---|
| Labeled for | Depression, Bipolar disorder, Schizophrenia | Schizophrenia |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $0.110 per tablet 5 mg tablet | $993.60 per mL 1,064 mg/3.9 mL syringe |
| Shortage now | No current entry | No current entry |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once