Drug Safety Information for CLOZAPINE (Clozapine)
FDA Safety Communication for CLOZAPINE (CLOZAPINE) Rx Drug: FDA Link
Strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz) can progress to serious bowel problems Drug Safety Communication
REMS for Clozapine (CLOZAPINE) Rx Drug: FDA Link
Shared FDA Risk Evaluation and Mitigation Strategy
Safety-related Labeling Changes for VERSACLOZ (CLOZAPINE) Rx Drug: FDA Link
Safety-related Labeling Changes for FAZACLO ODT (CLOZAPINE) Rx Drug: FDA Link
Safety-related Labeling Changes for CLOZARIL (CLOZAPINE) Rx Drug: FDA Link
Adverse Drug Reactions for CLOZAPINE* (Clozapine)
These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).
Top 20 Adverse Effects Associated with CLOZAPINE
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Death | 3656 |
2 | White blood cell count increased | 2602 |
3 | Granulocytopenia | 2163 |
4 | Neutrophil count increased | 1880 |
5 | White blood cell count decreased | 1525 |
6 | Leukopenia | 1460 |
7 | Pyrexia | 1406 |
8 | Pneumonia | 1390 |
9 | Malaise | 1382 |
10 | Tachycardia | 1281 |
11 | Neutrophil count decreased | 1136 |
12 | Psychotic disorder | 1115 |
13 | Fall | 1089 |
14 | Neutropenia | 1067 |
15 | Vomiting | 1030 |
16 | Haemoglobin decreased | 1018 |
17 | Drug interaction | 943 |
18 | Somnolence* | 915 |
19 | Dyspnoea | 875 |
20 | Convulsion | 844 |
* This side effect also appears in "Top 10 Side Effects of CLOZAPINE " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking CLOZAPINE
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Schizophrenia* | 69856 |
2 | Schizophrenia, paranoid type* | 6586 |
3 | Product used for unknown indication | 5420 |
4 | Schizoaffective disorder* | 4822 |
5 | Psychotic disorder* | 4147 |
6 | Bipolar disorder | 1771 |
7 | Schizophrenia, disorganised type | 484 |
8 | Hallucination | 452 |
9 | Parkinson's disease | 373 |
10 | Depression | 310 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for CLOZAPINE
Total Reports Filed with FDA: 133420
Number of FDA Adverse Event Reports by Patient Age for CLOZAPINE
Total Reports Filed with FDA: 133420*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Clozapine (Versacloz, Clozaril, Fazaclo odt, Fazaclo, Clozapine (fazaclo), Leponex, Clozapine)
Charts are based on 133420 reports filed with the FDA between 2004 and June 2015.
Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.
Click to go back to search results and CLOZAPINE Reviews and Review Summary .
Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.