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What the FDA labels say about taking them together

Clozapine and fluoxetine

Clozapine's FDA label of June 6, 2025 names fluoxetine in its drug interactions section, and fluoxetine's label names clozapine too. The fluoxetine label: “Elevation of blood levels of haloperidol and clozapine has been observed in patients receiving concomitant fluoxetine.”

Check it at the source: the clozapine FDA label on DailyMed (effective June 6, 2025, HLS Therapeutics (USA), Inc.); the fluoxetine FDA label on DailyMed (effective January 8, 2026, Dista Products Company).

What does the clozapine label say about fluoxetine?

Clozapine label, drug interactions

CYP2D6 and CYP3A4 Inhibitors Concomitant treatment with CLOZARIL and CYP2D6 or CYP3A4 inhibitors (e.g., cimetidine, escitalopram, erythromycin, paroxetine, bupropion, fluoxetine, quinidine, duloxetine, terbinafine, or sertraline) can increase clozapine levels and lead to adverse reactions [see Clinical Pharmacology ( 12.3 )].

Source: FDA drug label (Versacloz, NDA203479), TruPharma LLC, effective September 6, 2026 (SPL set 2592c9a8-fd74-4e0d-a895-b07b014cf355), via openFDA

Source: FDA drug label (Clozaril), NDA019758 (Heritage Life), as published by HLS Therapeutics (USA), Inc., effective June 6, 2025 (SPL set 90876802-0e3a-44c9-9ff7-1754dfbe736a), via openFDA; the full label on DailyMed

What does the fluoxetine label say about clozapine?

Fluoxetine label, drug interactions

Elevation of blood levels of haloperidol and clozapine has been observed in patients receiving concomitant fluoxetine.

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

11Clozapine generic labelers
58Fluoxetine generic labelers
ClozapineFluoxetine
Labeled forSchizophreniaDepression, Anxiety, Bipolar disorder
Boxed warningYesYes
Pharmacy cost (NADAC)$0.610 per tablet 100 mg tablet$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)

What next?