Quetiapine: Side Effects, Uses & Monitoring
1.1 Schizophrenia Quetiapine tablets, USP are indicated for the treatment of schizophrenia.
- Data source
- FDA labeling via NIH DailyMed (label d323b6c0…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| 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 reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
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…
Conditions associated with Quetiapine in labeling
Frequently Asked Questions
What is Quetiapine used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Quetiapine?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Quetiapine. Individual risk varies.
Does Quetiapine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Quetiapine.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.