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Tabulated list of adverse reactions: The incidences of ADRs associated with quetiapine therapy, are tabulated as follows (Table 1) according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group 1995). (See Tables 1a and 1b.)
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Click on icon to see table/diagram/imageCases of QT-prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and Torsades de Pointes have been reported with the use of antipsychotics and are considered class effects.
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with quetiapine treatment.
Paediatric population: The same ADRs described previously for adults should be considered for children and adolescents. The following table (Table 2) summarises ADRs that occur in a higher frequency category in children and adolescent patients (10-17 years of age) than in the adult population or ADRs that have not been identified in the adult population. (See Table 2.)
Click on icon to see table/diagram/imageReporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store.
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