This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: 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...
Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
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. ( 1.2 ) 1.1 Treatment-Resistant Schizophrenia CLOZARIL is indicated for the 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 [see Warnings and Precautions ( 5.1 , 5.4 )]. The effectiveness of CLOZARIL in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing CLOZARIL and chlorpromazine in patients w...
is contraindicated in patients with a history of hypersensitivity to clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, or Stevens-Johnson syndrome) or any other component of CLOZARIL [see Adverse Reactions ( 6.2 )]. Known hypersensitivity to clozapine or any other component of CLOZARIL. ( 4 )
• Severe neutropenia : See Boxed Warnings ( 5.1 ) • Gastrointestinal Hypomotility with Severe Complications : Severe gastrointestinal adverse reactions have occurred with the use of CLOZARIL. If constipation is identified, close monitoring and prompt treatment is advised. ( 5.7 ) • Eosinophilia : Assess for organ involvement (e.g., myocarditis, pancreatitis, hepatitis, colitis, nephritis). Discontinue if these occur. ( 5.8 ) • QT Interval Prolongation : Can be fatal. Consider additional risk factors for prolonged QT interval (disorders and drugs). ( 5.9 ) • Metabolic Changes : Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include: 1. Hyperglycemia and Diabetes Mellitus : Monitor for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes. ( 5.10 ) 2. Dyslipidemia : Undesirable alterations in lipids have occurred in patients treated with atypical antipsychotics. ( 5.10 ) 3. Weight Gain : Significant weight gain has occurred. Monitor weight gain. ( 5.10 ) • Neuroleptic Malignan...
The following adverse reactions are discussed in more detail in other sections of the labeling: • Severe Neutropenia [see Warnings and Precautions ( 5.1 )] • Orthostatic Hypotension, Bradycardia, and Syncope [see Warnings and Precautions ( 5.2 )] • Falls [see Warnings and Precautions ( 5.3 )] • Seizures [see Warnings and Precautions ( 5.4 )] • Myocarditis, Pericarditis, Cardiomyopathy, and Mitral Valve Incompetence [see Warnings and Precautions ( 5.5 )] • Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions ( 5.6 )] • Gastrointestinal Hypomotility with Severe Complications [See Warnings and Precautions ( 5.7) ] • Eosinophilia [see Warnings and Precautions ( 5.8 )] • QT Interval Prolongation [see Warnings and Precautions ( 5.9 )] • Metabolic Changes (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain) [see Warnings and Precautions ( 5.10 )] • Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.11 )] • Hepatotoxicity [see Warnings and Precautions ( 5.12 )] • Fever [see Warnings and Precautions ( 5.13 )] • Pulmonary Embolism [see Warnings and Precautions ( 5.14 )] • Anticholinergic Toxicity [see Warnings and...
Boxed Warning Dosage and Administration ( 2 ) Warnings and Precautions ( 5.1 ) 6/2025 6/2025 6/2025 Warnings and Precautions ( 5.5 ) 1/2025
Source: FDA SPL label for Clozaril (HLS Therapeutics (USA), Inc.), effective 20250606. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 9,057 | 9,558 | 8,659 | 13,919 | 13,134 | 11,703 | 8,284 | 3,393 |
19,493 reports blaming this drug for every million Medicare prescriptions filled, which is 7.0× the typical drug on this site. (23,021 reports in 2024–2026, against 1,180,978 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 06/2020 | 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. |
| 09/2018 | Class II | Teva Pharmaceuticals USA | Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $146,422 in payments to US physicians and hospitals tied to this drug across 165 transactions (clozapine $145,307, Clozaril $1,115).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Clozapine | 1,135,283 | $69 |
| Clozapine ODT | 36,574 | $454 |
| Clozaril | 8,193 | $1,444 |
| Versacloz | 928 | $1,454 |
2 drugs in the same class grade a letter or more higher than clozapine on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.