Quetiapine fumarate: adverse event reports filed with FDA

19,568

reports as suspect product

0.1% of all reports · about 870 a year

1,697

reports, 12 months to June 2026

2,163 in the 12 months before

90.7%

marked serious by the reporter

70.7% across the class

23.7%

record death among outcomes, as reported

4,633 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Quetiapine fumarate reports recording the termmedian drug in atypical antipsychotic

1. Drug ineffectivethe medicine did not work as expected11.7%2,286
2. Toxicity to various agentspoisoning or toxic effect of one or more substances10.3%2,023
3. Off label useused for a purpose or in a way not on the label10%1,954
4. Drug interactionan interaction between medicines8.8%1,715
5. Completed suicidedeath by suicide7.7%1,514
6. Headachehead pain6.2%1,217
7. Suicide attempta suicide attempt6.2%1,210
8. Overdosea dose above the recommended amount6.2%1,208
9. Weight increasedweight gain6.1%1,191
10. Condition aggravatedthe condition being treated got worse6%1,182
11. Fatiguetiredness6%1,171
12. Painpain, site not specified5.9%1,150
13. Hypertensionhigh blood pressure5.5%1,082
14. Depressionlow mood5.5%1,072
15. Nauseafeeling sick5.3%1,037
16. Vomitingbeing sick5.2%1,023
17. Dizzinesslight-headedness or unsteadiness5%981
18. Pyrexiafever5%977
19. Rashskin rash5%973
20. Exposure during pregnancythe medicine was taken during pregnancy4.9%965
21. Somnolencedrowsiness4.8%931
22. Prescribed overdose4.7%920
23. Product use issuea problem in how the product was used4.7%919
24. Hepatic enzyme increasedraised liver enzymes4.7%910
25. Anxietyanxiety4.5%885
26. Sedationdrowsiness from a medicine4.5%878
27. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease4.4%859
28. Confusional stateconfusion4.4%857
29. Drug abusemisuse of a medicine4.3%847
30. Product use in unapproved indicationused for a purpose not on the label4.2%822

Top 30 of 2,038 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 37 drugs in the atypical antipsychotic class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 683,680 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 23.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 19,568 reports.

Drugs most often listed in the same reports

Other products listed in reports where Quetiapine fumarate is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the atypical antipsychotic class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Quetiapine fumarate as a suspect or interacting product; reports listing it only as a concomitant medication (10,289) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.