Quetiapine: Side Effects, Uses & Monitoring
Facts extracted from current FDA product labeling for Quetiapine. Educational only — not medical advice.
Reported adverse reactions
| Reaction | Highest frequency reported* |
|---|---|
| Headache | 21% |
| Agitation | 20% |
| Somnolence | 18% |
| Extrapyramidal symptoms | 12.9% |
| Dizziness | 11% |
| Fatigue | 10% |
| Nausea | 10% |
| Dry mouth | 9% |
| Constipation | 8% |
| Tremor | 8% |
| Dystonic event | 7.8% |
| Parkinsonism | 7.8% |
| Other extrapyramidal event | 7.8% |
| Pain | 7% |
| Tachycardia | 6% |
| Vomiting | 6% |
| Asthenia | 5% |
| Dyspepsia | 5% |
| Weight gain | 5% |
| Alt increased | 5% |
*Highest percentage across placebo-controlled trial tables summarized in current labeling.
Labeled uses
1.1 Schizophrenia Quetiapine tablets, USP are indicated for the treatment of schizophrenia. The efficacy of Quetiapine tablets, USP in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). The effectiveness of Quetiapine tablets, USP for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)]. 1.2 Bipolar Disorder Quetiapine tablets, USP are indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10-17 years) [see Clinical Studies (14.2)]. Quetiapine tablets, USP are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies (14.2)]. Quetiapine tablets, USP are indicated for the maintenance treatm…
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