Zoloft: adverse event reports filed with FDA

21,311

reports as suspect product

0.1% of all reports · about 947 a year

295

reports, 12 months to June 2026

362 in the 12 months before

65.5%

marked serious by the reporter

83.7% across the class

6.1%

record death among outcomes, as reported

1,291 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 Zoloft reports recording the termmedian drug in serotonin reuptake inhibitor

1. Drug ineffectivethe medicine did not work as expected9.1%1,931
2. Anxietyanxiety7.3%1,566
3. Drug hypersensitivityan allergic-type reaction to a medicine6.6%1,409
4. Depressionlow mood6.4%1,357
5. Insomniadifficulty sleeping5.7%1,205
6. Feeling abnormalfeeling odd or not right5.2%1,098
7. Nauseafeeling sick5.1%1,095
8. Fatiguetiredness4.8%1,017
9. Headachehead pain4.7%1,000
10. Dizzinesslight-headedness or unsteadiness4.6%984
11. Suicidal ideationthoughts of suicide4.4%930
12. Maternal exposure during pregnancythe mother took the medicine during pregnancy3.8%819
13. Tremorshaking3.7%778
14. Suicide attempta suicide attempt3.4%719
15. Astheniaweakness or lack of energy3.3%713
16. Drug interactionan interaction between medicines3.1%667
17. Diarrhoealoose or frequent stools3.1%663
18. Weight increasedweight gain3.1%652
19. Somnolencedrowsiness3%647
20. Painpain, site not specified2.9%622
21. Malaisegeneral feeling of being unwell2.8%602
22. Vomitingbeing sick2.8%590
23. Dyspnoeashortness of breath2.5%527
24. Agitationrestlessness2.4%508
25. Irritabilityirritability2.4%502
26. Maternal exposure timing unspecified2.3%498
27. Condition aggravatedthe condition being treated got worse2.3%484
28. Cryingcrying2.3%483
29. Disturbance in attentiondifficulty concentrating2.2%477
30. Weight decreasedweight loss2.2%467

Top 30 of 2,215 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. 69.7% 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 21,311 reports.

Drugs most often listed in the same reports

Other products listed in reports where Zoloft 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 Zoloft as a suspect or interacting product; reports listing it only as a concomitant medication (59,466) 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.