What the FDA labels say about taking them together
Aripiprazole lauroxil and paroxetine
Aripiprazole lauroxil's FDA label of January 28, 2025 names paroxetine in its drug interactions section; the paroxetine labels PlainMeds reads (4) do not name aripiprazole lauroxil. 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 lauroxil FDA label on DailyMed (effective January 28, 2025, Alkermes, Inc.); the paroxetine FDA label on DailyMed (effective February 12, 2026, Mylan Pharmaceuticals Inc.).
What does the aripiprazole lauroxil label say about paroxetine?
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
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
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
What does the paroxetine label say about aripiprazole lauroxil?
Paroxetine's label (effective February 12, 2026) and its 3 other brand-application labels do not name aripiprazole lauroxil in these sections. A label lists what its studies and reports found; it is not a complete list.
Source: FDA drug label (Paroxetine), Mylan Pharmaceuticals Inc., effective February 12, 2026 (SPL set 89dd7e24-85fc-4152-89ea-47ec2b48a1ed), 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 lauroxil | Paroxetine | |
|---|---|---|
| Labeled for | Schizophrenia | Depression, Anxiety, Menopause symptoms |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $993.60 per mL 1,064 mg/3.9 mL syringe | $0.0611 per tablet 20 mg tablet |
| 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