Fluoxetine hcl: adverse event reports filed with FDA

1,013

reports as suspect product

0% of all reports · about 45 a year

4

reports, 12 months to June 2026

5 in the 12 months before

90.7%

marked serious by the reporter

83.7% across the class

21.8%

record death among outcomes, as reported

221 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 hcl reports recording the termmedian drug in serotonin reuptake inhibitor

1. Drug interactionan interaction between medicines10.2%103
2. Completed suicidedeath by suicide9.8%99
3. Drug exposure during pregnancythe medicine was taken during pregnancy6.2%63
4. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor5.3%54
5. Depressionlow mood4.8%49
6. Anxietyanxiety4.6%47
7. Suicide attempta suicide attempt4.2%43
8. Maternal exposure during pregnancythe mother took the medicine during pregnancy4%41
9. Cardiac arrestthe heart stopped3.9%40
10. Toxicity to various agentspoisoning or toxic effect of one or more substances3.6%36
11. Drug ineffectivethe medicine did not work as expected3.3%33
12. Overdosea dose above the recommended amount3.3%33
13. Suicidal ideationthoughts of suicide3.3%33
14. Insomniadifficulty sleeping3.1%31
15. Nauseafeeling sick3%30
16. Dizzinesslight-headedness or unsteadiness2.9%29
17. Tremorshaking2.9%29
18. Agitationrestlessness2.8%28
19. Drug hypersensitivityan allergic-type reaction to a medicine2.8%28
20. Vomitingbeing sick2.8%28
21. Condition aggravatedthe condition being treated got worse2.7%27
22. Respiratory arrestbreathing stopped2.7%27
23. Abortion spontaneousmiscarriage2.6%26
24. Aggressionaggressive behaviour2.5%25
25. Deaththe patient died; cause not stated by this term2.5%25
26. Fatiguetiredness2.5%25
27. Somnolencedrowsiness2.5%25
28. Dyspnoeashortness of breath2.1%21
29. Feeling abnormalfeeling odd or not right2.1%21
30. Headachehead pain2.1%21

Top 30 of 345 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. 36.6% 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 1,013 reports.

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 hcl as a suspect or interacting product; reports listing it only as a concomitant medication (4,323) 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.