Paroxetine: adverse event reports filed with FDA

16,204

reports as suspect product

0.1% of all reports · about 720 a year

1,170

reports, 12 months to June 2026

1,134 in the 12 months before

93%

marked serious by the reporter

83.7% across the class

18.6%

record death among outcomes, as reported

3,006 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 Paroxetine reports recording the termmedian drug in serotonin reuptake inhibitor

1. Drug interactionan interaction between medicines9.5%1,534
2. Toxicity to various agentspoisoning or toxic effect of one or more substances8.7%1,410
3. Drug abusemisuse of a medicine7%1,129
4. Drug ineffectivethe medicine did not work as expected6.3%1,022
5. Completed suicidedeath by suicide6%976
6. Anxietyanxiety5.4%879
7. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor5.4%878
8. Confusional stateconfusion5.4%877
9. Somnolencedrowsiness4.8%771
10. Suicidal ideationthoughts of suicide4.7%765
11. Nauseafeeling sick4.5%723
12. Tremorshaking4.2%673
13. Dizzinesslight-headedness or unsteadiness4.1%669
14. Depressionlow mood4.1%667
15. Agitationrestlessness4.1%660
16. Headachehead pain3.9%640
17. Fatiguetiredness3.9%638
18. Insomniadifficulty sleeping3.7%606
19. Vomitingbeing sick3.6%591
20. Suicide attempta suicide attempt3.6%590
21. Paraesthesiatingling or pins and needles3.3%534
22. Falla fall3.2%526
23. Hyperhidrosisexcessive sweating3.2%513
24. Drug withdrawal syndromesymptoms on stopping a medicine3.1%509
25. Hyponatraemialow blood sodium3.1%508
26. Intentional overdosea deliberate overdose3.1%501
27. Condition aggravatedthe condition being treated got worse3.1%498
28. Foetal exposure during pregnancythe unborn baby was exposed to the medicine3%488
29. Off label useused for a purpose or in a way not on the label2.9%471
30. Diarrhoealoose or frequent stools2.9%468

Top 30 of 1,956 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. 24.5% 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 16,204 reports.

Drugs most often listed in the same reports

Other products listed in reports where Paroxetine 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 Paroxetine as a suspect or interacting product; reports listing it only as a concomitant medication (17,628) 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.