Leponex Adverse Reactions

Summary of the safety profile: The adverse effects of clozapine are most often predictable based on its pharmacological properties with the exception of agranulocytosis (see Precautions).
The most serious adverse reactions experienced with clozapine are agranulocytosis, seizure, cardiovascular effects and fever (see Precautions). The most common side effects are drowsiness/sedation, dizziness, tachycardia, constipation, and hypersalivation.
Data from the clinical trials experience showed that a varying proportion of clozapine-treated patients (from 7.1 to 15.6%) were discontinued due to an adverse event, including only those that could be reasonably attributed to clozapine. The more common events considered to be causes of discontinuation were leukopenia; somnolence; dizziness (excluding vertigo); and psychotic disorder.
Adverse drug reactions (ADRs) are listed by MedDRA system organ class (see Table 3). Within each system organ class, the adverse reactions are ranked by frequency, using the following convention: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.

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Very rare events of ventricular tachycardia, cardiac arrest and QT prolongation which may be associated with Torsades De Pointes have been observed although there is no conclusive causal relationship to the use of this medicine.
Adverse drug reactions from spontaneous reports and literature (frequency not known): The following adverse drug reactions (ADRs) were derived from post-marketing experience with clozapine (Leponex) via spontaneous case reports and literature cases and have been categorized according to MedDRA system organ class (see Table 4). Because these reactions have been reported voluntarily from a population of uncertain size and are subject to confounding factors, these post-marketing ADRs have been categorized with a frequency of "not known" since it is not possible to reliably estimate their frequency. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness.

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