Trazodone hydrochloride: adverse event reports filed with FDA

4,213

reports as suspect product

0% of all reports · about 192 a year

364

reports, 12 months to June 2026

375 in the 12 months before

82.2%

marked serious by the reporter

83.7% across the class

21.9%

record death among outcomes, as reported

921 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 Trazodone hydrochloride reports recording the termmedian drug in serotonin reuptake inhibitor

1. Drug ineffectivethe medicine did not work as expected11.3%476
2. Completed suicidedeath by suicide8%338
3. Drug interactionan interaction between medicines8%335
4. Toxicity to various agentspoisoning or toxic effect of one or more substances7.2%304
5. Headachehead pain6.7%284
6. Drug abusemisuse of a medicine6.6%277
7. Off label useused for a purpose or in a way not on the label6%253
8. Painpain, site not specified5.5%230
9. Somnolencedrowsiness5.1%215
10. Product use in unapproved indicationused for a purpose not on the label4.8%202
11. Vomitingbeing sick4.8%202
12. Suicide attempta suicide attempt4.7%200
13. Sopor4.5%189
14. Insomniadifficulty sleeping4.4%184
15. Nauseafeeling sick4.2%179
16. Gastrooesophageal reflux diseaseacid reflux4.2%177
17. Migrainemigraine4.2%176
18. Dyspnoeashortness of breath4.1%173
19. Fatiguetiredness4.1%171
20. Dizzinesslight-headedness or unsteadiness4%169
21. Intentional overdosea deliberate overdose3.7%156
22. Drug hypersensitivityan allergic-type reaction to a medicine3.6%153
23. Confusional stateconfusion3.5%146
24. Astheniaweakness or lack of energy3.2%136
25. Memory impairmentmemory problems3.2%134
26. Cardio-respiratory arrestthe heart and breathing stopped3.1%132
27. Abdominal pain upperupper stomach pain3%128
28. Overdosea dose above the recommended amount2.9%121
29. Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor2.8%120
30. Falla fall2.8%118

Top 30 of 860 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. 47.3% 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 4,213 reports.

Drugs most often listed in the same reports

Other products listed in reports where Trazodone 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 Trazodone hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (11,744) 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.