Paxil: adverse event reports filed with FDA

24,193

reports as suspect product

0.1% of all reports · about 1,076 a year

56

reports, 12 months to June 2026

88 in the 12 months before

57%

marked serious by the reporter

83.7% across the class

4.4%

record death among outcomes, as reported

1,061 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 Paxil reports recording the termmedian drug in serotonin reuptake inhibitor

1. Drug withdrawal syndromesymptoms on stopping a medicine16.4%3,976
2. Drug exposure during pregnancythe medicine was taken during pregnancy13.1%3,161
3. Drug ineffectivethe medicine did not work as expected9.3%2,243
4. Dizzinesslight-headedness or unsteadiness8.8%2,122
5. Foetal exposure during pregnancythe unborn baby was exposed to the medicine8.8%2,121
6. Anxietyanxiety8.1%1,962
7. Nauseafeeling sick7.3%1,766
8. Suicidal ideationthoughts of suicide6.2%1,505
9. Headachehead pain5.8%1,393
10. Depressionlow mood5.7%1,380
11. Insomniadifficulty sleeping5.4%1,317
12. Paraesthesiatingling or pins and needles5.2%1,260
13. Atrial septal defect5.2%1,256
14. Fatiguetiredness4.7%1,148
15. Congenital anomalya condition present at birth4.7%1,142
16. Tremorshaking4.7%1,130
17. Weight increasedweight gain4.6%1,124
18. Agitationrestlessness3.9%943
19. Hyperhidrosisexcessive sweating3.9%938
20. Aggressionaggressive behaviour3.8%930
21. Feeling abnormalfeeling odd or not right3.8%928
22. Ventricular septal defect3.4%834
23. Vomitingbeing sick3.1%750
24. Cardiac murmur3.1%741
25. Confusional stateconfusion3.1%741
26. Patent ductus arteriosus3%727
27. Diarrhoealoose or frequent stools3%714
28. Disturbance in attentiondifficulty concentrating2.9%710
29. Somnolencedrowsiness2.8%686
30. Irritabilityirritability2.8%677

Top 30 of 1,924 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. 64.3% 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 24,193 reports.

Drugs most often listed in the same reports

Other products listed in reports where Paxil 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 Paxil as a suspect or interacting product; reports listing it only as a concomitant medication (24,434) 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.