85/100 · Critical
Manufactured by HLS Therapeutics (USA), Inc.
High Safety Concerns with Clozapine Due to Serious Adverse Reactions
207,229 FDA adverse event reports analyzed
Last updated: 2026-05-12
CLOZAPINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by HLS Therapeutics (USA), Inc.. Based on analysis of 207,229 FDA adverse event reports, CLOZAPINE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for CLOZAPINE include NEUTROPENIA, HOSPITALISATION, DEATH, SCHIZOPHRENIA, WHITE BLOOD CELL COUNT INCREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CLOZAPINE.
Clozapine has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 207,229 adverse event reports for this medication, which is primarily manufactured by Hls Therapeutics (Usa), Inc..
The most commonly reported adverse events include Neutropenia, Hospitalisation, Death. Of classified reports, 94.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Neutropenia and agranulocytosis are the most serious and frequent adverse reactions.
Hospitalization and death are common, indicating severe health impacts. Drug interactions and overuse are significant safety signals.
Patients taking Clozapine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Clozapine requires strict monitoring for neutropenia and agranulocytosis, and caution is advised with other medications due to potential interactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Clozapine received a safety concern score of 85/100 (high concern). This is based on a 94.7% serious event ratio across 121,298 classified reports. The score accounts for 207,229 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 65,492, Female: 41,716, Unknown: 209. The most frequently reported age groups are age 56 (1,565 reports), age 47 (1,511 reports), age 58 (1,507 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 121,298 classified reports for CLOZAPINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Clozapine requires strict monitoring for neutropenia and agranulocytosis, and caution is advised with other medications due to potential interactions.
If you are taking Clozapine, here are important things to know. The most commonly reported side effects include neutropenia, hospitalisation, death, schizophrenia, white blood cell count increased. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Regularly monitor blood counts and report any signs of infection or fever. Do not stop or change the dosage without consulting a healthcare provider. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Clozapine is subject to strict FDA oversight and requires regular blood tests to monitor for severe side effects.
The FDA has received approximately 207,229 adverse event reports associated with Clozapine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Clozapine include Neutropenia, Hospitalisation, Death, Schizophrenia, White Blood Cell Count Increased. By volume, the top reported reactions are: Neutropenia (18,655 reports), Hospitalisation (12,101 reports), Death (11,402 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Clozapine.
Out of 121,298 classified reports, 114,824 (94.7%) were classified as serious and 6,474 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Clozapine break down by patient sex as follows: Male: 65,492, Female: 41,716, Unknown: 209. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Clozapine adverse events are: age 56: 1,565 reports, age 47: 1,511 reports, age 58: 1,507 reports, age 53: 1,482 reports, age 59: 1,474 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Clozapine adverse event reports is Hls Therapeutics (Usa), Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Clozapine include: White Blood Cell Count Decreased, Neutrophil Count Increased, Drug Ineffective, Malaise, Off Label Use. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Clozapine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Clozapine has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Neutropenia and agranulocytosis are the most serious and frequent adverse reactions.
Key safety signals identified in Clozapine's adverse event data include: Neutropenia and agranulocytosis. Hospitalization and death. Drug interactions. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Clozapine requires strict monitoring for neutropenia and agranulocytosis, and caution is advised with other medications due to potential interactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Clozapine.
Regularly monitor blood counts and report any signs of infection or fever. Do not stop or change the dosage without consulting a healthcare provider.
Clozapine has 207,229 adverse event reports on file with the FDA. Hospitalization and death are common, indicating severe health impacts. The volume of reports for Clozapine reflects both the drug's usage level and the vigilance of the reporting community.
Clozapine is subject to strict FDA oversight and requires regular blood tests to monitor for severe side effects. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with CLOZAPINE:
Drugs related to CLOZAPINE based on therapeutic use, drug class, or shared indications: