Paroxetine hydrochloride: adverse event reports filed with FDA

8,935

reports as suspect product

0% of all reports · about 397 a year

268

reports, 12 months to June 2026

232 in the 12 months before

84.2%

marked serious by the reporter

83.7% across the class

14%

record death among outcomes, as reported

1,255 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 hydrochloride reports recording the termmedian drug in serotonin reuptake inhibitor

1. Suicidal ideationthoughts of suicide10.5%938
2. Anxietyanxiety10.3%924
3. Drug ineffectivethe medicine did not work as expected10.3%918
4. Drug withdrawal syndromesymptoms on stopping a medicine10%895
5. Dizzinesslight-headedness or unsteadiness8.7%773
6. Depressionlow mood8.6%767
7. Nauseafeeling sick8.3%739
8. Fatiguetiredness6.9%618
9. Confusional stateconfusion6.8%612
10. Tremorshaking6.8%605
11. Drug interactionan interaction between medicines6.7%603
12. Paraesthesiatingling or pins and needles6.6%594
13. Agitationrestlessness6.6%593
14. Headachehead pain6.4%574
15. Hyperhidrosisexcessive sweating6.1%543
16. Insomniadifficulty sleeping6%535
17. Completed suicidedeath by suicide5.3%478
18. Drug exposure during pregnancythe medicine was taken during pregnancy5.3%472
19. Aggressionaggressive behaviour5.2%462
20. Toxicity to various agentspoisoning or toxic effect of one or more substances4.8%425
21. Vomitingbeing sick4.7%423
22. Memory impairmentmemory problems4.7%420
23. Disturbance in attentiondifficulty concentrating4.6%410
24. Somnolencedrowsiness4.5%405
25. Diarrhoealoose or frequent stools4.5%399
26. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor4.4%396
27. Suicide attempta suicide attempt4.3%382
28. Panic attacka panic attack4.2%377
29. Weight increasedweight gain4.1%366
30. Nightmarenightmares4%355

Top 30 of 1,516 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. 33.3% 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 8,935 reports.

Drugs most often listed in the same reports

Other products listed in reports where Paroxetine 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 Paroxetine hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (8,852) 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.