Cymbalta: adverse event reports filed with FDA

52,279

reports as suspect product

0.3% of all reports · about 2,395 a year

346

reports, 12 months to June 2026

412 in the 12 months before

52.3%

marked serious by the reporter

66.4% across the class

3%

record death among outcomes, as reported

1,589 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 Cymbalta reports recording the termmedian drug in serotonin and norepinephrine reuptake inhibitor

1. Nauseafeeling sick14.8%7,758
2. Dizzinesslight-headedness or unsteadiness14.3%7,478
3. Drug withdrawal syndromesymptoms on stopping a medicine14%7,331
4. Insomniadifficulty sleeping11.1%5,814
5. Headachehead pain10.8%5,649
6. Fatiguetiredness10.6%5,523
7. Paraesthesiatingling or pins and needles10.1%5,304
8. Anxietyanxiety9.7%5,053
9. Suicidal ideationthoughts of suicide8%4,174
10. Hyperhidrosisexcessive sweating7.8%4,084
11. Agitationrestlessness7.3%3,813
12. Drug ineffectivethe medicine did not work as expected7.2%3,785
13. Irritabilityirritability7.2%3,746
14. Feeling abnormalfeeling odd or not right7%3,668
15. Diarrhoealoose or frequent stools6.6%3,436
16. Depressionlow mood6.2%3,226
17. Vomitingbeing sick6.2%3,218
18. Painpain, site not specified6.1%3,200
19. Confusional stateconfusion6.1%3,187
20. Vertigoa spinning sensation5.8%3,058
21. Off label useused for a purpose or in a way not on the label5.7%2,996
22. Tremorshaking5.2%2,733
23. Affect lability4.8%2,506
24. Dysphoria4.4%2,306
25. Somnolencedrowsiness4%2,098
26. Malaisegeneral feeling of being unwell3.8%2,007
27. Tinnitusringing in the ears3.5%1,804
28. Nightmarenightmares3.4%1,792
29. Lethargysluggishness3.3%1,736
30. Sensory disturbancea change in sensation3.1%1,624

Top 30 of 2,717 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. 74.3% 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 52,279 reports.

Drugs most often listed in the same reports

Other products listed in reports where Cymbalta 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 Cymbalta as a suspect or interacting product; reports listing it only as a concomitant medication (69,250) 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.