Apo-Quetiapine Adverse Reactions

The most commonly reported Adverse Drug Reactions (ADRs) 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 edema, have been associated with quetiapine.
The incidences of ADRs associated with quetiapine therapy, are tabulated as follows according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group; 1995). (See table.)

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Extrapyramidal Symptoms: The following clinical trials (monotherapy and combination therapy) included treatment with quetiapine.
In short-term, placebo-controlled clinical trials in schizophrenia and bipolar mania the aggregated incidence of extrapyramidal symptoms was similar to placebo (schizophrenia: 7.8% for quetiapine and 8.0% for placebo, bipolar mania: 11.2% for quetiapine and 11.4% for placebo). In long-term studies of schizophrenia and bipolar disorder the aggregated exposure adjusted incidence of treatment-emergent extrapyramidal symptoms was similar between quetiapine and placebo.
Thyroid Level: 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.
About 0.7% (26/3489) of quetiapine patients experienced Thyroid Stimulating Hormone (TSH) increases in monotherapy studies. Six of the patients with TSH increases needed replacement thyroid treatment. In the mania adjunct studies, 12% (24/196) of the quetiapine treated patients compared to 7% (15/203) placebo treated patients had elevated TSH levels.
As with other antipsychotics, quetiapine may be associated with weight gain, predominantly during the early weeks of treatment.
As with other antipsychotics, quetiapine may cause prolongation of the QTc interval, but in clinical trials, this was not associated with a persistent increase (see Precautions).
Acute withdrawal reactions have been reported (see Precautions).
Post-Market Adverse Reactions: Hepatic failure, including fatalities, has also been reported very rarely during the post-marketing period.
Based on post-marketing experience, there is a potential risk of somnambulisn (sleep walking) and sleep-related eating disorder with the use of atypical antipsychotics drugs, including quetiapine.