Seroquel: adverse event reports filed with FDA

52,272

reports as suspect product

0.3% of all reports · about 2,324 a year

265

reports, 12 months to June 2026

503 in the 12 months before

62.9%

marked serious by the reporter

70.7% across the class

6.6%

record death among outcomes, as reported

3,443 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 Seroquel reports recording the termmedian drug in atypical antipsychotic

1. Diabetes mellitusdiabetes13.9%7,270
2. Drug dose omissiona dose was missed10.4%5,447
3. Insomniadifficulty sleeping9%4,715
4. Type 2 diabetes mellitustype 2 diabetes7.4%3,855
5. Weight increasedweight gain6.4%3,363
6. Off label useused for a purpose or in a way not on the label6.3%3,317
7. Pancreatitisinflammation of the pancreas5.8%3,010
8. Somnolencedrowsiness5.2%2,700
9. Depressionlow mood4.2%2,221
10. Anxietyanxiety4.2%2,197
11. Feeling abnormalfeeling odd or not right4%2,075
12. Malaisegeneral feeling of being unwell3.8%2,009
13. Drug ineffectivethe medicine did not work as expected3.8%1,987
14. Suicidal ideationthoughts of suicide3.2%1,665
15. Fatiguetiredness3.2%1,654
16. Dizzinesslight-headedness or unsteadiness3.2%1,651
17. Suicide attempta suicide attempt2.8%1,481
18. Blood cholesterol increasedraised cholesterol2.8%1,453
19. Falla fall2.8%1,452
20. Nauseafeeling sick2.7%1,400
21. Deaththe patient died; cause not stated by this term2.6%1,366
22. Headachehead pain2.6%1,353
23. Tremorshaking2.6%1,337
24. Drug interactionan interaction between medicines2.4%1,271
25. Vomitingbeing sick2.3%1,227
26. Obesity2.3%1,211
27. Overdosea dose above the recommended amount2.3%1,181
28. Agitationrestlessness2.3%1,177
29. Ketoacidosis2.2%1,164
30. Confusional stateconfusion2.2%1,144

Top 30 of 2,761 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. 77.2% 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 52,272 reports.

Drugs most often listed in the same reports

Other products listed in reports where Seroquel 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 Seroquel as a suspect or interacting product; reports listing it only as a concomitant medication (35,224) 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.