Qtipine 25/Qtipine 100/Qtipine 300 Adverse Reactions

The most commonly reported Adverse Drug Reactions (ADRs) with quetiapine (≥10%): somnolence, dizziness, headache, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.
The incidences of ADRs associated with quetiapine therapy, are tabulated as follows (Tables 1 and 2) according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group 1995). (See Tables 1 and 2.)
Qtipine 25 and Qtipine 300: See Table 1.

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Qtipine 100: The frequencies of adverse events are ranked according to the following: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10,000, <1/1000), Very rare (<1/10,000), and Not known (cannot be estimated from the available data). (See Table 2.)

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Paediatric Population: The same ADRs described previously for adults should be considered for children and adolescents. The following table summarizes 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.
Table 3 shows ADRs in children and adolescents associated with quetiapine therapy that occur in a higher frequency than adults, or not identified in the adult population. The frequencies of adverse events are ranked according to the following: Very common (>1/10), Common (>1/100, <1/10), Uncommon (>1/1000, <1/100), Rare (>1/10,000, <1/1000) and Very rare (<1/10,000). (See Table 3.)

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Reporting of suspected adverse reactions: Qtipine 100: 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.