Zyprexa: adverse event reports filed with FDA

26,469

reports as suspect product

0.1% of all reports · about 1,177 a year

121

reports, 12 months to June 2026

155 in the 12 months before

78.4%

marked serious by the reporter

70.7% across the class

11.4%

record death among outcomes, as reported

3,020 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 Zyprexa reports recording the termmedian drug in atypical antipsychotic

1. Diabetes mellitusdiabetes14.4%3,809
2. Weight increasedweight gain13.5%3,576
3. Off label useused for a purpose or in a way not on the label5.2%1,381
4. Pancreatitisinflammation of the pancreas5%1,336
5. Drug ineffectivethe medicine did not work as expected4.9%1,292
6. Hypertensionhigh blood pressure4.8%1,268
7. Overdosea dose above the recommended amount4.1%1,075
8. Metabolic disorder4%1,065
9. Suicide attempta suicide attempt3.9%1,032
10. Blood glucose increasedraised blood sugar reading3.8%1,019
11. Hyperglycaemiahigh blood sugar3.7%970
12. Sedationdrowsiness from a medicine3.5%937
13. Anxietyanxiety3.5%917
14. Somnolencedrowsiness3.5%916
15. Prescribed overdose3.3%869
16. General physical health deteriorationgeneral decline in health3.2%843
17. Blood triglycerides increased3.1%830
18. Insomniadifficulty sleeping3.1%809
19. Deaththe patient died; cause not stated by this term3%784
20. Injurya physical injury2.9%755
21. Blood cholesterol increasedraised cholesterol2.8%746
22. Dyskinesiainvoluntary movements2.8%744
23. Diabetic ketoacidosisa serious complication of diabetes with acid build-up2.8%732
24. Obesity2.7%724
25. Depressionlow mood2.7%707
26. Condition aggravatedthe condition being treated got worse2.7%705
27. Fatiguetiredness2.5%668
28. Tremorshaking2.5%666
29. Drug interactionan interaction between medicines2.5%663
30. Falla fall2.4%648

Top 30 of 2,259 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. 51.1% 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 26,469 reports.

Drugs most often listed in the same reports

Other products listed in reports where Zyprexa 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 Zyprexa as a suspect or interacting product; reports listing it only as a concomitant medication (12,726) 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.