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What the FDA labels say about taking them together

Aripiprazole lauroxil and fluoxetine

Aripiprazole lauroxil's FDA label of January 28, 2025 names fluoxetine in its drug interactions section; fluoxetine'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 fluoxetine FDA label on DailyMed (effective January 8, 2026, Dista Products Company).

What does the aripiprazole lauroxil label say about fluoxetine?

Aripiprazole lauroxil label, 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. 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 interactions

Strong 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 fluoxetine label say about aripiprazole lauroxil?

Fluoxetine's label does not name aripiprazole lauroxil itself; it warns about its class (Atypical antipsychotics):

Fluoxetine label, drug interactions

Use PROZAC with caution in combination with other drugs that cause QT prolongation. These include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin);

Fluoxetine label, warnings and precautions

Avoid the concomitant use of drugs known to prolong the QT interval. These include specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol,); specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin);

Source: FDA drug label (Prozac), NDA018936 (Eli Lilly And Co), as published by Dista Products Company, effective January 8, 2026 (SPL set c88f33ed-6dfb-4c5e-bc01-d8e36dd97299), 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

0Aripiprazole lauroxil generic labelers
58Fluoxetine generic labelers
Aripiprazole lauroxilFluoxetine
Labeled forSchizophreniaDepression, Anxiety, Bipolar disorder
Boxed warningYesYes
Pharmacy cost (NADAC)$993.60 per mL 1,064 mg/3.9 mL syringe$0.0519 per capsule 40 mg capsule
Shortage nowNo current entryNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

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