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Quetiapine Side Effects

The most commonly reported side effects of quetiapine include off label use, toxicity to various agents, and fatigue, based on 191,472 FDA adverse event reports from 2004 to 2025. 5.8% of reports found the drug to be ineffective.

#1 Reported: Off Label UseAll side effects ↓Top Co-Medication: OlanzapineDrug interactions ↓72% of Reports Are AdultDemographics ↓

Quetiapine side effects

Percentages show how often each reaction appears relative to total reports for quetiapine.

1
Drug Ineffective5.8%11,122
2
Off Label Use5.5%10,462
3
Toxicity To Various Agents5.1%9,701
4
Fatigue4.0%7,566
5
Diabetes Mellitus3.9%7,470
6
Drug Interaction3.8%7,214
7
Nausea3.4%6,570
8
Somnolence3.3%6,257
9
Pain3.1%6,023
10
Anxiety3.1%5,940
11
Depression3.1%5,864
12
Insomnia2.9%5,623
13
Weight Increased2.9%5,604
14
Dizziness2.9%5,591
15
Completed Suicide2.9%5,565

These are voluntary reports and do not establish that quetiapine caused these reactions.

Report severity

79.2%Serious151,622 reports
36.6%Hospitalizations70,126 reports
14.6%Fatal27,916 reports

Seriousness is determined by the reporter, not by OpenClaim.

Quetiapine drug interactions

Other drugs that appear in adverse event reports alongside quetiapine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Olanzapine5.1%9,728
2
Risperidone4.7%8,911
3
Aripiprazole4.3%8,286
4
Acetaminophen3.6%6,931
5
Venlafaxine3.3%6,326
6
Lamotrigine3.2%6,132
7
Sertraline-hydrochloride3.2%6,121
8
Lorazepam2.8%5,326
9
Adalimumab2.8%5,272
10
Clozapine2.7%5,136
11
Clonazepam2.7%5,086
12
Pregabalin2.6%5,009
13
Bupropion2.5%4,815
14
Oxycodone2.5%4,798
15
Pimavanserin2.4%4,627

Taken alongside

1
Acetaminophen7.8%14,881
2
Levothyroxine-sodium6.5%12,395
3
Clonazepam6.4%12,323
4
Lorazepam6.2%11,921
5
Gabapentin5.6%10,717
6
Aspirin5.4%10,430
7
Pantoprazole-sodium5.4%10,333
8
Ergocalciferol4.9%9,469
9
Sertraline-hydrochloride4.9%9,337
10
Atorvastatin-calcium4.6%8,846
11
Omeprazole4.6%8,725
12
Albuterol4.4%8,368
13
Trazodone-hydrochloride4.2%8,127
14
Lisinopril4.1%7,835
15
Metformin4.0%7,617

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports quetiapine side effects

54.9% of quetiapine adverse event reports involve female patients and 37.7% involve male patients. The largest age group is adult at 72%. These figures reflect who reports side effects, not underlying risk.

Sex

Female54.9%
Male37.7%
Unknown7.4%

Age group

< 21.4%
2–110.9%
12–173.3%
18–6471.6%
65+22.8%

What is quetiapine used for

Conditions and purposes for which patients were taking quetiapine when the adverse event was reported.

22q11.2 Deletion SyndromeAbdominal PainAbdominal Pain UpperAbnormal BehaviourAbnormal DreamsAbnormal Sleep-related EventAbortion SpontaneousAbuliaAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAccidental OverdoseAcute ManiaAcute Myocardial InfarctionAcute Psychosis

Showing 15 of 1,340 indications

Quetiapine brand names and reporting trend

Quetiapine is sold under the brand name Seroquel Xr.

Brand names

Seroquel Xr1,593

Quarterly reports (2004–2025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking quetiapine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.

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