Prescription medicine
Clozapine Brand names: Clozaril, Versacloz
Clozapine (Clozaril) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $0.610 per clozapine 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the clozapine FDA label on DailyMed (effective June 6, 2025, HLS Therapeutics (USA), Inc.); the NDA 19758 record on Drugs@FDA; every clozapine label on DailyMed.
Highlights of the record
FDA label of June 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS, PERICARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
Severe Neutropenia CLOZARIL has caused severe neutropenia which is associated with an increased risk of serious and potentially fatal infections. Prior to initiating CLOZARIL treatment, obtain baseline ANC(s). CLOZARIL initiation is not recommended in patients with a baseline ANC less than 1500/μL (less than 1000/μL for those with Benign Ethnic Neutropenia (also known as Duffy-null associated neutrophil count)). See recommendations for dosage modifications based on ANC levels during CLOZARIL treatment [see Dosage and Administration ( 2.3 , 2.4 )]. Consider a hematology consultation before initiating CLOZARIL or during CLOZARIL treatment [see Warnings and Precautions ( 5.1 )]. Orthostatic Hypotension, Bradycardia, Syncope Orthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with CLOZARIL treatment. The risk is highest during the initial titration period, particularly with rapid dose escalation. These reactions can occur with the first dose, with doses as low as 12.5 mg per day, or when restarting patients who have had even a brief interruption in treatment with CLOZARIL. […]
Used for
From the label: indications and usageCLOZARIL is an atypical antipsychotic indicated for:
Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment.
Forms and strengths
- 12.5 mg
- 25 mg
- 50 mg
- 100 mg
- 150 mg
- 200 mg
- 50 mg/ml
Tablet; orally disintegrating tablet; suspension.
On the market
- Earliest approval on file
- September 26, 1989 Clozaril, Heritage Life; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first August 30, 1996; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 11 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- May 1, 2028 Versacloz oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.610 per tablet Clozapine 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2017 0 Class I among all firms' recalls; latest June 12, 2020
- FAERS reports
- 124,829 through July 30, 2026
What is clozapine used for?
From the label: indications and usageCLOZARIL is an atypical antipsychotic indicated for:
Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the risks of severe neutropenia and of seizure associated with its use, CLOZARIL should be used only in patients who have failed to respond adequately to standard antipsychotic treatment ( 1.1 )
Reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior. […]
Conditions named in the indications of clozapine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Atypical Antipsychotic.
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 patient leaflet for clozapine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about CLOZARIL?CLOZARIL can cause serious side effects including: • Severe neutropenia (low white blood cell (WBC) counts) that can lead to serious infections and death. Your healthcare provider will do WBC blood tests before starting treatment with CLOZARIL and weekly for the first 6 months. After your first 6 months of treatment, your healthcare provider will determine how frequent you will have blood tests. If you have symptoms of severe neutropenia or an infection, your healthcare provider will do more frequent WBC blood test(s) to check if CLOZARIL is causing your symptoms and may send you to see a blood specialist (hematologist). Tell your health care provider right away if you have any of the following symptoms or signs of neutropenia or infection: o feel like you have the flu • wounds that take a long time to heal o fever or chills • skin, throat, vaginal, urinary tract, or lung infection o feel extremely tired or weak • pain or burning while peeing o sores or ulcers inside your mouth, gums, or on your skin • unusual vaginal discharge or itching o sores or pain in or around your rectal area • abdominal pain or bloating • Orthostatic hypotension (decreased blood pressure), bradycardia (slow heart rate), or syncope (fainting) that can lead to death. You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Tell your healthcare provider right away if you feel dizzy or pass out. • Seizures. See “What should I avoid while taking CLOZARIL?” • Myocarditis (heart muscle inflammation), pericarditis (inflammation of outer layer of the heart) and cardiomyopathy (heart muscle weakness) that can lead to death. […]
From the patient leaflet: What should I avoid while taking CLOZARIL?You should not drink alcohol while taking CLOZARIL because it can increase your chances of getting serious side effects. • Do not drive, operate machinery, swim, climb, or do dangerous activities until you know how CLOZARIL affects you.
From the patient leaflet: How should I store CLOZARIL?Store CLOZARIL at room temperature between 68°F to 77°F (20°C to 25°C). Keep CLOZARIL and all medicines out of the reach of children.
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
Is there a generic for clozapine (Clozaril)?
The FDA approved the first generic clozapine on August 30, 1996. 13 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists clozapine from 11 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Clozaril tablets; a patent listed only for Versacloz oral suspension runs to May 1, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1989 earliest approval on file
- 1996 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clozapine (Clozaril)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.610 per Clozapine 100 mg tablet, up 5% from $0.580 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Clozapine 100 mg tablet (generic)
- Clozaril 25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clozapine 100 mg tablet | Generic | $0.610 per tablet | $18.31 | +5% |
| Clozapine 200 mg tablet | Generic | $0.969 per tablet | $29.07 | +8% |
| Clozapine 25 mg tablet | Generic | $0.242 per tablet | $7.27 | -9% |
| Clozapine 50 mg tablet | Generic | $0.542 per tablet | $16.25 | +6% |
| Clozapine ODT 100 mg tablet | Generic | $4.26 per tablet | $127.94 | -0.2% |
| Clozapine ODT 150 mg tablet | Generic | $14.97 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $449.13 | -10% |
| Clozapine ODT 200 mg tablet | Generic | $21.20 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $636.10 | +1% |
| Clozapine ODT 25 mg tablet | Generic | $1.66 per tablet | $49.74 | -11% |
| Clozaril 100 mg tablet | Brand | $16.83 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $504.99 | +3% |
| Clozaril 25 mg tablet | Brand | $6.54 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $196.34 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has clozapine been recalled?
The FDA's Enforcement Report lists 4 recalls naming clozapine since 2017: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2020 | Class II | Aurobindo Pharma USA Inc. | Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg. |
| September 21, 2018 | Class II | Teva Pharmaceuticals USA | Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing. |
| November 9, 2017 | Class II | Teva Pharmaceuticals USA | Failed Tablet/Capsule Specifications; potential presence of broken tablets. |
| April 24, 2017 | Class II | Teva Pharmaceuticals USA | Microbial Contamination of Non-Sterile Products |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clozapine label say about other medicines?
The clozapine label names 36 other medicines in its interaction, contraindication or warning sections. The labels of 25 other medicines name clozapine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | … sparfloxacin), Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class III antiarrhythmics (e.g., amiodarone, sotalol), and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus) [see Warnings and Precautions ( 5.9 )]. |
| Benztropine | drug interactions | Anticholinergic Drugs Concomitant treatment with clozapine and other drugs with anticholinergic activity (e.g., benztropine, cyclobenzaprine, diphenhydramine) can increase the risk for anticholinergic toxicity and severe gastrointestinal adverse reactions related to hypomotility. |
| Bupropion | 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 … |
| Caffeine | drug interactions | Moderate or weak CYP1A2 inhibitors include oral contraceptives and caffeine. |
| Carbamazepine | drug interactions | Discontinuation of CYP1A2 or CYP3A4 Inducers: Consider reducing CLOZARIL dose when CYP1A2 inducers (e.g., tobacco smoke) or CYP3A4 inducers (e.g., carbamazepine) are discontinued. |
| Chlorpromazine | drug interactions | Drugs that cause QT prolongation include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, thioridazine, mesoridazine, droperidol, and pimozide), specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin), Class 1A antiarrhythmics (e.g., quinidine, procainamide) or … |
| Cimetidine | 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 … |
| Ciprofloxacin | drug interactions | Concomitant use of Strong CYP1A2 Inhibitors: Reduce CLOZARIL dose to one-third when coadministered with strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, enoxacin). |
| Cyclobenzaprine | drug interactions | Anticholinergic Drugs Concomitant treatment with clozapine and other drugs with anticholinergic activity (e.g., benztropine, cyclobenzaprine, diphenhydramine) can increase the risk for anticholinergic toxicity and severe gastrointestinal adverse reactions related to hypomotility. |
| Diphenhydramine | drug interactions | Anticholinergic Drugs Concomitant treatment with clozapine and other drugs with anticholinergic activity (e.g., benztropine, cyclobenzaprine, diphenhydramine) can increase the risk for anticholinergic toxicity and severe gastrointestinal adverse reactions related to hypomotility. |
| Droperidol | drug interactions | Drugs that cause QT prolongation include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, thioridazine, mesoridazine, droperidol, and pimozide), specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin), Class 1A antiarrhythmics (e.g., quinidine, procainamide) or … |
| Duloxetine | 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 … |
| Erythromycin | 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 … |
| Escitalopram | 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 … |
Every other medicine the clozapine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Flecainide | drug interactions | Such drugs include specific antidepressants, phenothiazines, carbamazepine, and Type 1C antiarrhythmics (e.g., propafenone, flecainide, and encainide). |
| Fluoxetine | drug interactions | … (e.g., cimetidine, escitalopram, erythromycin, paroxetine, bupropion, fluoxetine, quinidine, duloxetine, terbinafine, or sertraline) can increase clozapine levels and lead to adverse reactions [see … |
| Fluvoxamine | drug interactions | Concomitant use of Strong CYP1A2 Inhibitors: Reduce CLOZARIL dose to one-third when coadministered with strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, enoxacin). |
| Gatifloxacin | drug interactions | … droperidol, and pimozide), specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin), Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class III antiarrhythmics … |
| Iloperidone | drug interactions | Drugs that cause QT prolongation include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, thioridazine, mesoridazine, droperidol, and pimozide), specific antibiotics (e.g. … |
| Mefloquine | drug interactions | … (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus) [see Warnings and Precautions ( 5.9 )]. |
| Methadone | drug interactions | … amiodarone, sotalol), and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus) [see Warnings and Precautions ( 5.9 )]. |
| Moxifloxacin | drug interactions | … pimozide), specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin), Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class III antiarrhythmics (e.g. … |
| Olanzapine | warnings and precautions | The median duration of exposure was 609, 728, and 42 days, in the CLOZARIL, olanzapine, and chlorpromazine group, respectively. |
| Paroxetine | drug interactions | CYP2D6 and CYP3A4 Inhibitors Concomitant treatment with CLOZARIL and CYP2D6 or CYP3A4 inhibitors (e.g., cimetidine, escitalopram, erythromycin, paroxetine, bupropion, fluoxetine, quinidine … |
| Phenytoin | drug interactions | Strong CYP3A4 inducers include carbamazepine, phenytoin, St. John’s wort, and rifampin. |
| Pimozide | drug interactions | … iloperidone, chlorpromazine, thioridazine, mesoridazine, droperidol, and pimozide), specific antibiotics (e.g., erythromycin, gatifloxacin, moxifloxacin, sparfloxacin), Class 1A antiarrhythmics … |
| Procainamide | drug interactions | … moxifloxacin, sparfloxacin), Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class III antiarrhythmics (e.g., amiodarone, sotalol), and others (e.g., pentamidine, levomethadyl acetate … |
| Propafenone | drug interactions | Such drugs include specific antidepressants, phenothiazines, carbamazepine, and Type 1C antiarrhythmics (e.g., propafenone, flecainide, and encainide). |
| Quinidine | drug interactions | … cimetidine, escitalopram, erythromycin, paroxetine, bupropion, fluoxetine, quinidine, duloxetine, terbinafine, or sertraline) can increase clozapine levels and lead to adverse reactions [see Clinical … |
| Rifampin | drug interactions | Strong CYP3A4 inducers include carbamazepine, phenytoin, St. John’s wort, and rifampin. |
| Sertraline | drug interactions | … paroxetine, bupropion, fluoxetine, quinidine, duloxetine, terbinafine, or sertraline) can increase clozapine levels and lead to adverse reactions [see Clinical Pharmacology ( 12.3 )]. |
| Sotalol | drug interactions | … quinidine, procainamide) or Class III antiarrhythmics (e.g., amiodarone, sotalol), and others (e.g., pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate … |
| Tacrolimus | drug interactions | … methadone, halofantrine, mefloquine, dolasetron mesylate, probucol or tacrolimus) [see Warnings and Precautions ( 5.9 )]. |
| Terbinafine | drug interactions | … erythromycin, paroxetine, bupropion, fluoxetine, quinidine, duloxetine, terbinafine, or sertraline) can increase clozapine levels and lead to adverse reactions [see Clinical Pharmacology ( 12.3 )]. |
| Thioridazine | drug interactions | Drugs that cause QT prolongation include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, thioridazine, mesoridazine, droperidol, and pimozide), specific antibiotics (e.g. … |
| Ziprasidone | drug interactions | Drugs that cause QT prolongation include: specific antipsychotics (e.g., ziprasidone, iloperidone, chlorpromazine, thioridazine, mesoridazine, droperidol, and pimozide), specific antibiotics (e.g. … |
Other labels that name clozapine
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 do FAERS reports show for clozapine?
The FDA Adverse Event Reporting System holds 124,829 reports that list clozapine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 22,310 are coded as a death and 54,629 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as clozapine?
20 other medicines are given the same way (oral) and in the same FDA class as clozapine or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Quetiapine | Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Aripiprazole | Schizophrenia | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Olanzapine | Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Risperidone | Schizophrenia | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Lurasidone | Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Ziprasidone | Schizophrenia | 16 labelers | $0.269 per capsule 20 mg capsule | No current entry |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
| Iloperidone | Schizophrenia | 1 labeler | $60.01 per tablet 12 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does clozapine compare with medicines for the same use?
6 side-by-side pages set clozapine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to clozapine
- 20 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Clozapine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other