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What the FDA labels say about taking them together

Clozapine and paroxetine

Clozapine's FDA label of June 6, 2025 names paroxetine in its drug interactions section; the paroxetine labels PlainMeds reads (4) do not name clozapine. The clozapine label: “CYP2D6 and CYP3A4 Inhibitors Concomitant treatment with CLOZARIL and CYP2D6 or CYP3A4 inhibitors can increase clozapine levels and lead to adverse reactions.”

Check it at the source: the clozapine FDA label on DailyMed (effective June 6, 2025, HLS Therapeutics (USA), Inc.); the paroxetine FDA label on DailyMed (effective February 12, 2026, Mylan Pharmaceuticals Inc.).

What does the clozapine label say about paroxetine?

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 paroxetine label say about clozapine?

Paroxetine's label (effective February 12, 2026) and its 3 other brand-application labels do not name clozapine 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

11Clozapine generic labelers
45Paroxetine generic labelers
ClozapineParoxetine
Labeled forSchizophreniaDepression, Anxiety, Menopause symptoms
Boxed warningYesYes
Pharmacy cost (NADAC)$0.610 per tablet 100 mg tablet$0.0611 per tablet 20 mg tablet
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?