Sertraline hydrochloride: adverse event reports filed with FDA

11,077

reports as suspect product

0.1% of all reports · about 504 a year

1,080

reports, 12 months to June 2026

938 in the 12 months before

85.2%

marked serious by the reporter

83.7% across the class

15.6%

record death among outcomes, as reported

1,731 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 Sertraline hydrochloride reports recording the termmedian drug in serotonin reuptake inhibitor

1. Drug interactionan interaction between medicines10.6%1,176
2. Depressionlow mood8.4%931
3. Drug ineffectivethe medicine did not work as expected7.4%816
4. Headachehead pain6.4%706
5. Nauseafeeling sick6.1%672
6. Toxicity to various agentspoisoning or toxic effect of one or more substances5.5%610
7. Dizzinesslight-headedness or unsteadiness5.4%600
8. Anxietyanxiety5.4%596
9. Diarrhoealoose or frequent stools4.7%518
10. Fatiguetiredness4.5%493
11. Off label useused for a purpose or in a way not on the label4.3%481
12. Dyspnoeashortness of breath4.3%478
13. Insomniadifficulty sleeping4.1%451
14. Vomitingbeing sick4%443
15. Malaisegeneral feeling of being unwell3.8%426
16. Somnolencedrowsiness3.6%402
17. Falla fall3.4%382
18. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor3.4%372
19. Intentional overdosea deliberate overdose3.3%363
20. Suicidal ideationthoughts of suicide3.3%361
21. Completed suicidedeath by suicide3.2%360
22. Condition aggravatedthe condition being treated got worse3.2%355
23. Suicide attempta suicide attempt3.2%350
24. Tremorshaking3%334
25. Astheniaweakness or lack of energy2.9%321
26. Coughcough2.8%313
27. Loss of personal independence in daily activities2.8%313
28. Decreased appetitereduced appetite2.8%310
29. Pruritusitching2.7%303
30. Tachycardiafast heart rate2.7%295

Top 30 of 1,666 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. 30.5% 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 11,077 reports.

Drugs most often listed in the same reports

Other products listed in reports where Sertraline 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 Sertraline hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (14,591) 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.