Fluoxetine hydrochloride: adverse event reports filed with FDA

6,209

reports as suspect product

0% of all reports · about 278 a year

648

reports, 12 months to June 2026

622 in the 12 months before

91.9%

marked serious by the reporter

83.7% across the class

19%

record death among outcomes, as reported

1,177 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 hydrochloride reports recording the termmedian drug in serotonin reuptake inhibitor

1. Drug interactionan interaction between medicines12.1%750
2. Toxicity to various agentspoisoning or toxic effect of one or more substances10.9%674
3. Intentional overdosea deliberate overdose10.4%647
4. Suicide attempta suicide attempt8.4%524
5. Off label useused for a purpose or in a way not on the label7%433
6. Drug ineffectivethe medicine did not work as expected6.9%428
7. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor6.7%419
8. Completed suicidedeath by suicide6.5%403
9. Drug abusemisuse of a medicine5.8%358
10. Dizzinesslight-headedness or unsteadiness5.4%333
11. Headachehead pain5.1%316
12. Nauseafeeling sick4.9%307
13. Foetal exposure during pregnancythe unborn baby was exposed to the medicine4.8%300
14. Cardio-respiratory arrestthe heart and breathing stopped4.8%299
15. Somnolencedrowsiness4.8%298
16. Coma4.8%295
17. Dyspnoeashortness of breath4.5%279
18. Acute kidney injurysudden loss of kidney function4.4%271
19. Insomniadifficulty sleeping4.4%271
20. Falla fall4.3%270
21. Metabolic acidosistoo much acid in the body fluids4.2%258
22. Tachycardiafast heart rate4.1%256
23. Fatiguetiredness4%250
24. Diarrhoealoose or frequent stools3.9%244
25. Vomitingbeing sick3.8%233
26. Malaisegeneral feeling of being unwell3.6%226
27. Suicidal ideationthoughts of suicide3.6%223
28. Major depressionmajor depression3.6%222
29. Physical deconditioning3.5%216
30. Anxietyanxiety3.2%201

Top 30 of 1,148 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. 30.6% 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 6,209 reports.

Drugs most often listed in the same reports

Other products listed in reports where Fluoxetine hydrochloride 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 hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (6,583) 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.