Pristiq: adverse event reports filed with FDA

5,941

reports as suspect product

0% of all reports · about 333 a year

81

reports, 12 months to June 2026

127 in the 12 months before

41.8%

marked serious by the reporter

66.4% across the class

2.5%

record death among outcomes, as reported

149 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 Pristiq reports recording the termmedian drug in serotonin and norepinephrine reuptake inhibitor

1. Drug ineffectivethe medicine did not work as expected11.7%694
2. Feeling abnormalfeeling odd or not right9.1%539
3. Anxietyanxiety8.1%479
4. Dizzinesslight-headedness or unsteadiness7.7%460
5. Withdrawal syndrome7.4%439
6. Nauseafeeling sick7.4%438
7. Malaisegeneral feeling of being unwell6.9%409
8. Headachehead pain6.4%383
9. Depressionlow mood6.4%381
10. Insomniadifficulty sleeping4.9%294
11. Suicidal ideationthoughts of suicide4.8%283
12. Drug withdrawal syndromesymptoms on stopping a medicine4.7%280
13. Off label useused for a purpose or in a way not on the label4.5%266
14. Fatiguetiredness4.4%261
15. Intentional product misusedeliberate use not as intended4%236
16. Cryingcrying3.8%228
17. Painpain, site not specified3.4%202
18. Condition aggravatedthe condition being treated got worse3.2%192
19. Hyperhidrosisexcessive sweating2.9%174
20. Drug hypersensitivityan allergic-type reaction to a medicine2.9%170
21. Drug dependencedependence on a medicine2.8%164
22. Irritabilityirritability2.7%163
23. Tremorshaking2.7%158
24. Vomitingbeing sick2.6%152
25. Paraesthesiatingling or pins and needles2.5%148
26. Weight increasedweight gain2.3%137
27. Memory impairmentmemory problems2.3%136
28. Diarrhoealoose or frequent stools2.2%133
29. Nervousnessnervousness2.2%131
30. Somnolencedrowsiness2.1%125

Top 30 of 643 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 12 drugs in the serotonin and norepinephrine 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 171,115 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. 84.8% 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 5,941 reports.

Drugs most often listed in the same reports

Other products listed in reports where Pristiq 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 and norepinephrine 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 Pristiq as a suspect or interacting product; reports listing it only as a concomitant medication (6,666) 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.