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The most commonly reported adverse drug reactions with quetiapine are somnolence, dizziness, dry mouth, mild asthenia, constipation, tachycardia, orthostatic hypotension, and dyspepsia. As with other antipsychotics, weight gain, syncope, neuroleptic malignant syndrome, leucopenia, neutropenia and peripheral oedema, have been associated with quetiapine.
Blood and lymphatic system disorders: Common: Leucopenia.
Uncommon: Thrombocytopenia.
Unknown: Neutropenia.
Immune system disorders: Uncommon: Hypersensitivity.
Very rare: Anaphylactic reaction.
Endocrine disorders: Common: Hyperprolactinaemia.
Metabolism and nutritional disorders: Common: Increased appetite.
Very rare: Diabetes mellitus.
Psychiatric disorders: Common: Abnormal dreams and nightmares.
Rare: Somnambulism and other related reactions.
Nervous system disorders: Very Common: Dizziness, somnolence, headache, extrapyramidal symptoms.
Common: Dysarthria.
Uncommon: Seizure, restless legs syndrome, tardive dyskinesia, syncope.
Cardiac disorders: Common: Tachycardia, palpitations.
Uncommon: Bradycardia.
Eye Disorders: Common: Vision blurred.
Renal and urinary disorders: Uncommon: Urinary retention.
Vascular disorders: Common: Orthostatic hypotension.
Respiratory, thoracic and mediastinal disorder: Common: Dyspnoea.
Uncommon: Rhinitis.
Gastrointestinal disorders: Very common: Dry mouth.
Common: Constipation, dyspepsia, vomiting.
Uncommon: Dysphagia.
Rare: Intestinal obstruction/ Ileus.
Hepato-biliary disorders: Rare: Jaundice.
Very rare: Hepatitis.
Skin and subcutaneous tissue disorders: Very rare: Angioedema, Stevens-Johnson syndrome.
Reproductive system and breast disorders: Rare: Priapism, galactorrhoea.
General disorders and administration site conditions: Very common: Withdrawal (discontinuation) symptoms.
Common: Mild asthenia, peripheral oedema, irritability, pyrexia.
Rare: Neuroleptic malignant syndrome, hypothermia.
Not known: Neonatal withdrawal.
Investigations: Very common: Elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased hemoglobin.
Common: Elevations in serum alanine aminotransferase (ALT), elevations in gamma-GT levels, decreased neutrophil count, eosinophils increased, blood glucose increased to hyperglycaemic levels, QT prolongation, elevations in serum prolactin, decreases in Total T4, decreases in Free T4, decreases in Total T3, increases in TSH.
Uncommon: Elevations in serum aspartate aminotransferase (AST), platelet count decreased, decreases in free T3.
Rare: Elevations in blood creatine phosphokinase, agranulocytosis.
Cases of QT prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and torsade de pointes have been reported with the use of neuroleptics and are considered class effects.
Quetiapine treatment was associated with small dose-related decreases in thyroid hormone levels, particularly total T4 and free T4. The reduction in total and free T4 was maximal within the first two to four weeks of quetiapine treatment, with no further reduction during long-term treatment. In nearly all cases, cessation of Quetiapine treatment was associated with a reversal of the effects on total and free T4, irrespective of the duration of treatment. Smaller decreases in total T3 and reverse T3 were seen only at higher doses. Levels of TBG were unchanged and in general, reciprocal increases in TSH were not observed, with no indication that Quetiapine causes clinically relevant hypothyroidism.
Children and adolescents (10 to 17 years of age): The same ADRs described previously for adults should be considered for children and adolescents. The following 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.
Metabolism and nutritional disorders: Very common: Increased appetite.
Investigations: Very common: Elevations in prolactin, increases in blood pressure.
Nervous system disorders: Common: Syncope.
General disorders and administration site conditions: Common: Irritability.
Respiratory, thoracic, and mediastinal disorders: Common: Rhinitis.
Gastrointestinal disorders: Very common: Vomiting.
