Fluoxetine: adverse event reports filed with FDA

28,319

reports as suspect product

0.1% of all reports · about 1,259 a year

1,734

reports, 12 months to June 2026

1,804 in the 12 months before

93%

marked serious by the reporter

83.7% across the class

23.7%

record death among outcomes, as reported

6,718 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 Fluoxetine reports recording the termmedian drug in serotonin reuptake inhibitor

1. Toxicity to various agentspoisoning or toxic effect of one or more substances11%3,129
2. Completed suicidedeath by suicide10.7%3,044
3. Drug interactionan interaction between medicines10.6%2,999
4. Intentional overdosea deliberate overdose6.3%1,774
5. Drug ineffectivethe medicine did not work as expected6%1,686
6. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor5.9%1,668
7. Drug abusemisuse of a medicine4.5%1,265
8. Suicide attempta suicide attempt4.1%1,151
9. Suicidal ideationthoughts of suicide3.9%1,111
10. Anxietyanxiety3.9%1,097
11. Nauseafeeling sick3.5%987
12. Somnolencedrowsiness3.2%908
13. Depressionlow mood3.2%897
14. Overdosea dose above the recommended amount3.1%892
15. Tremorshaking3.1%890
16. Dizzinesslight-headedness or unsteadiness3%861
17. Off label useused for a purpose or in a way not on the label3%859
18. Condition aggravatedthe condition being treated got worse3%853
19. Vomitingbeing sick3%846
20. Electrocardiogram QT prolongeda QT prolongation on the ECG2.9%811
21. Cardiac arrestthe heart stopped2.8%785
22. Fatiguetiredness2.7%776
23. Deaththe patient died; cause not stated by this term2.7%768
24. Hypotensionlow blood pressure2.6%746
25. Agitationrestlessness2.6%745
26. Cardio-respiratory arrestthe heart and breathing stopped2.6%732
27. Headachehead pain2.6%728
28. Insomniadifficulty sleeping2.4%685
29. Confusional stateconfusion2.4%683
30. Dyspnoeashortness of breath2.2%637

Top 30 of 2,449 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 21 drugs in the serotonin reuptake inhibitor 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 273,115 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. 40.9% 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 28,319 reports.

Drugs most often listed in the same reports

Other products listed in reports where Fluoxetine 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 serotonin reuptake inhibitor 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 Fluoxetine as a suspect or interacting product; reports listing it only as a concomitant medication (39,115) 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.