Clozaril Drug Warnings:

There have been 34 drug regulatory agency warnings from seven countries (Australia, Canada, Denmark, New Zealand, South Africa, United Kingdom and United States) on Clozaril (or clozapine). These include the following (note that some warnings cite more than one side effect, so the list below may not be equal to the total number of warnings):

13 warnings on Clozaril causing cardiovascular disorders
8 warnings on Clozaril causing death or increased risk of death
8 warnings on Clozaril causing heart problems
7 warnings on Clozaril causing gastrointestinal problems
6 warnings on Clozaril causing blood disorders
3 warnings on Clozaril causing blood pressure changes or high or low blood pressure
3 warnings on Clozaril causing weight gain
3 warnings on Clozaril causing liver problems
2 warnings on Clozaril causing nervous system disorders
2 warnings on Clozaril causing metabolic disorders
2 warnings on Clozaril causing newborn complications (including infant withdrawal symptoms)
2 warnings on Clozaril causing muscle problems
2 warnings on Clozaril causing sleep problems
2 warnings on Clozaril causing diabetes
1 warning on Clozaril causing involuntary movements
1 warning on Clozaril causing stroke
1 warning on Clozaril causing sexual dysfunction
1 warning on Clozaril causing Neuroleptic Malignant Syndrome (a life-threatening neurological disorder)
1 warning on Clozaril causing risk of fractures
1 warning on Clozaril causing sedation
1 warning on Clozaril causing pneumonia

Clozaril Drug Studies:

There have been 31 studies done in 15 countries (Australia, Bosnia and Herzegovina, Brazil, Canada, Denmark, France, Ireland, Italy, Netherlands, New Zealand, Switzerland, Taiwan, Turkey, United Kingdom and United States) on Clozaril (or clozapine). These include the following (note that some studies cite more than one side effect, so the list below may not be equal to the total number of studies):

7 studies on Clozaril causing cardiovascular disorders
6 studies on Clozaril causing death or increased risk of death
5 studies on Clozaril causing diabetes
5 studies on Clozaril causing metabolic disorders
3 studies on Clozaril causing heart problems
2 studies on Clozaril causing weight gain
2 studies on Clozaril causing skin conditions
2 studies on Clozaril causing newborn complications
2 studies on Clozaril causing heart attacks
2 studies on Clozaril causing pregnancy complications
2 studies on Clozaril causing gastrointestinal problems
1 study on Clozaril causing nervous system disorders
1 study on Clozaril causing involuntary movements
1 study on Clozaril causing muscle problems
1 study on Clozaril causing Neuroleptic Malignant Syndrome (a life-threatening neurological disorder)
1 study on Clozaril causing allergic reactions
1 study on Clozaril causing premature birth
1 study on Clozaril causing infant withdrawal symptoms
1 study on Clozaril causing brain shrinkage or other structural brain changes
1 study on Clozaril causing blood disorders
1 study on Clozaril causing coma
1 study on Clozaril causing birth defects

Adverse Reaction Reports Filed with the US FDA: There have been 18,554 adverse reactions reported to the US FDA in connection with Clozaril (clozapine).

The FDA estimates that less than 1% of all serious events are ever reported to it, so the actual number of side effects occurring are most certainly higher.

• 2,348 cases of death
• 1,494 cases of granulocytopenia (white blood cell disease)
• 918 cases of white blood cell count increased
• 899 cases of leukopenia (low white blood cell count)
• 853 cases of pyrexia (fever)
• 828 cases of pneumonia
• 783 cases of white blood cell count decreased
• 757 cases of malaise (unease or discomfort)
• 754 cases of tachycardia (rapid heart rate)
• 623 cases of neutrophil (type of white blood cell) count decreased

Documented Side Effects of Clozaril:
Source: Physicians Desk Reference, National Institutes of Health’s Medline Plus, and/or the drug label.