Skip to main content

What the FDA labels say about taking them together

Clozapine and sertraline

Clozapine's FDA label of June 6, 2025 names sertraline in its drug interactions section; sertraline's label does not name clozapine itself but warns about its class (Atypical antipsychotics). 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 sertraline FDA label on DailyMed (effective August 8, 2023, Viatris Specialty LLC).

What does the clozapine label say about sertraline?

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 sertraline label say about clozapine?

Sertraline's label does not name clozapine itself; it warns about its class (Atypical antipsychotics):

Sertraline label, drug interactions

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

Source: FDA drug label (Zoloft), Viatris Specialty LLC, effective August 8, 2023 (SPL set fda754f6-d0f3-4dce-a17a-927d64f912f7), 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
47Sertraline generic labelers
ClozapineSertraline
Labeled forSchizophreniaDepression, Anxiety
Boxed warningYesYes
Pharmacy cost (NADAC)$0.610 per tablet 100 mg tablet$0.0507 per tablet 100 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?