What the FDA labels say about taking them together
Aripiprazole lauroxil and itraconazole
Aripiprazole lauroxil's FDA label of January 28, 2025 names itraconazole in its drug interactions section; itraconazole'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 lauroxil FDA label on DailyMed (effective January 28, 2025, Alkermes, Inc.); the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.).
What does the aripiprazole lauroxil label say about itraconazole?
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 itraconazole label say about aripiprazole lauroxil?
Itraconazole's label does not name aripiprazole lauroxil itself; it warns about its class (Atypical antipsychotics):
Itraconazole label, drug interactionsAntipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions.
Source: FDA drug label (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), 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 | Itraconazole | |
|---|---|---|
| Labeled for | Schizophrenia | Fungal infections |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $993.60 per mL 1,064 mg/3.9 mL syringe | $0.910 per capsule 100 mg capsule |
| Shortage now | No current entry | A presentation being discontinued |
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