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CLOZARIL

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Clozaril Adverse Events Reported to the FDA Over Time

How are Clozaril adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Clozaril, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Clozaril is flagged as the suspect drug causing the adverse event.

Most Common Clozaril Adverse Events Reported to the FDA

What are the most common Clozaril adverse events reported to the FDA?

White Blood Cell Count Increased
2008 (2.08%)
White Blood Cell Count Decreased
1834 (1.9%)
Malaise
1550 (1.61%)
Death
1544 (1.6%)
Neutrophil Count Increased
1479 (1.54%)
Neutrophil Count Decreased
1478 (1.53%)
Haemoglobin Decreased
1230 (1.28%)
Tachycardia
1209 (1.26%)
Lower Respiratory Tract Infection
1084 (1.13%)
Pyrexia
1084 (1.13%)
Platelet Count Decreased
1026 (1.07%)
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Neutropenia
1018 (1.06%)
Vomiting
948 (.98%)
Pneumonia
891 (.93%)
Fall
885 (.92%)
Urinary Tract Infection
779 (.81%)
Psychotic Disorder
757 (.79%)
Somnolence
744 (.77%)
Dyspnoea
738 (.77%)
Mental Impairment
704 (.73%)
Antipsychotic Drug Level Increased
689 (.72%)
Overdose
669 (.69%)
C-reactive Protein Increased
652 (.68%)
Dizziness
643 (.67%)
Mental Disorder
635 (.66%)
Constipation
620 (.64%)
Confusional State
618 (.64%)
Heart Rate Increased
575 (.6%)
Convulsion
541 (.56%)
Schizophrenia
529 (.55%)
Blood Creatine Phosphokinase Increa...
512 (.53%)
Salivary Hypersecretion
512 (.53%)
Sedation
512 (.53%)
Infection
508 (.53%)
Diarrhoea
485 (.5%)
Platelet Count Increased
474 (.49%)
Alanine Aminotransferase Increased
461 (.48%)
Treatment Noncompliance
459 (.48%)
Agitation
454 (.47%)
Sinus Tachycardia
434 (.45%)
Electrocardiogram Qt Prolonged
431 (.45%)
Hypotension
429 (.45%)
Weight Decreased
428 (.44%)
Asthenia
413 (.43%)
Chest Pain
413 (.43%)
Diabetes Mellitus
407 (.42%)
Loss Of Consciousness
405 (.42%)
Eosinophil Count Increased
391 (.41%)
General Physical Health Deteriorati...
390 (.4%)
Fatigue
387 (.4%)
Circulatory Collapse
382 (.4%)
Hypertension
381 (.4%)
Myocardial Infarction
372 (.39%)
Body Temperature Increased
367 (.38%)
Liver Function Test Abnormal
356 (.37%)
Nausea
352 (.37%)
Cardiac Disorder
347 (.36%)
Blood Alkaline Phosphatase Increase...
343 (.36%)
Hepatitis C
341 (.35%)
Anaemia
324 (.34%)
Myocarditis
318 (.33%)
Influenza Like Illness
314 (.33%)
Anxiety
312 (.32%)
Dehydration
307 (.32%)
Weight Increased
303 (.31%)
Chronic Obstructive Pulmonary Disea...
301 (.31%)
Neuroleptic Malignant Syndrome
294 (.31%)
Agranulocytosis
292 (.3%)
Differential White Blood Cell Count...
292 (.3%)
Thrombocytopenia
292 (.3%)
Lung Neoplasm Malignant
290 (.3%)
Sepsis
284 (.29%)
Syncope
279 (.29%)
Drug Interaction
273 (.28%)
Hyperhidrosis
273 (.28%)
Headache
271 (.28%)
Abdominal Pain
262 (.27%)
Gamma-glutamyltransferase Increased
262 (.27%)
Leukopenia
261 (.27%)
Lymphocyte Count Decreased
258 (.27%)
Neoplasm Malignant
254 (.26%)
Orthostatic Hypotension
248 (.26%)
Blood Glucose Increased
243 (.25%)
Electrocardiogram Abnormal
242 (.25%)
Cough
241 (.25%)
Blood Pressure Increased
238 (.25%)
Haematocrit Decreased
238 (.25%)
Renal Impairment
235 (.24%)
Cerebrovascular Accident
233 (.24%)
Drug Level Increased
233 (.24%)
Monocyte Count Increased
230 (.24%)
Aggression
226 (.23%)
Obesity
225 (.23%)
Renal Failure
225 (.23%)
Red Blood Cell Count Decreased
223 (.23%)
Tremor
221 (.23%)
Troponin Increased
221 (.23%)
Cardiac Arrest
220 (.23%)
Hallucination, Auditory
216 (.22%)
Blood Creatinine Increased
213 (.22%)
Gait Disturbance
211 (.22%)

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This graph shows the top adverse events submitted to the FDA for Clozaril, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Clozaril is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Clozaril

What are the most common Clozaril adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Clozaril, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Clozaril is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Clozaril According to Those Reporting Adverse Events

Why are people taking Clozaril, according to those reporting adverse events to the FDA?

Schizophrenia
11937
Psychotic Disorder
372
Schizoaffective Disorder
345
Schizophrenia, Paranoid Type
312
Parkinsons Disease
113
Bipolar Disorder
100
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Product Used For Unknown Indication
52
Drug Use For Unknown Indication
44
Medication Error
33
Hallucination
23
Agitation
21
Depression
20
Schizophrenia, Disorganised Type
17
Dementia With Lewy Bodies
14
Dementia
13
Intentional Self-injury
12
Personality Disorder
10
Major Depression
10
Mania
10
Borderline Personality Disorder
10
Affective Disorder
9
Accidental Exposure
9
Obsessive-compulsive Disorder
8
Abnormal Behaviour
8
Schizophrenia, Undifferentiated Typ...
8
Schizoaffective Disorder Bipolar Ty...
8
Delusional Disorder, Unspecified Ty...
8
Schizophrenia, Catatonic Type
7
Constipation
7
Dyspepsia
7
Paranoia
7
Disease Recurrence
6
Hallucination, Auditory
6
Aggression
6
Post-traumatic Stress Disorder
6
Parkinsonism
5
Convulsion
5
Ill-defined Disorder
5
Tardive Dyskinesia
4
Catatonia
4
Confusional State
4
Delusional Disorder, Persecutory Ty...
4
Schizophrenia, Residual Type
4
Delusion
4
Bipolar I Disorder
4
Mental Disorder
4
Developmental Delay
3
Intermittent Explosive Disorder
3
Self Injurious Behaviour
3
Movement Disorder
3
Delirium
3

Drug Labels

LabelLabelerEffective
ClozarilCardinal Health09-NOV-12
ClozarilNovartis Pharmaceuticals Corporation30-MAR-13

Clozaril Case Reports

What Clozaril safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Clozaril. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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