BOXED WARNINGS: Due to the risk of agranulocytosis, a potentially life-threatening adverse event, clozapine should be reserved for (1) severely ill patients with schizophrenia who fail to respond adequately to standard drug treatment, or (2) patients with schizophrenia or schizoaffective disorder at risk of recurrent suicidal behaviour. Patients being treated with clozapine must have their blood tested for a baseline white blood cell (WBC) count and absolute neutrophil count (ANC) before initiation of treatment, and have regular WBC counts and ANCs during treatment and for at least 4 weeks after discontinuation of treatment.

Analyses of post-marketing safety databases suggest that clozapine is associated with an increased risk of fatal myocarditis, especially during the first month of therapy. In patients in whom myocarditis is suspected, clozapine treatment should be promptly discontinued.

Seizures have been associated with clozapine, with a greater likelihood at higher doses.

Orthostatic hypotension, a rapid drop in blood pressure that makes you feel faint or dizzy, with or without collapse, can occur with clozapine treatment. Rarely, collapse can be profound and be accompanied by respiratory and/or cardiac arrest. Orthostatic hypotension is more likely to occur during initial dosing, in association with a rapid dose escalation.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. FazaClo is not approved for the treatment of those patients.