Tramadol hydrochloride: adverse event reports filed with FDA

27,447

reports as suspect product

0.1% of all reports · about 1,253 a year

1,952

reports, 12 months to June 2026

2,250 in the 12 months before

92.4%

marked serious by the reporter

91.7% across the class

22.8%

record death among outcomes, as reported

6,267 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 Tramadol hydrochloride reports recording the termmedian drug in opioid agonist

1. Dependence28.5%7,822
2. Overdosea dose above the recommended amount14%3,833
3. Vomitingbeing sick10.4%2,841
4. Painpain, site not specified8.3%2,271
5. Drug dependencedependence on a medicine7.9%2,178
6. Nauseafeeling sick7.5%2,054
7. Drug ineffectivethe medicine did not work as expected7.5%2,047
8. Drug hypersensitivityan allergic-type reaction to a medicine7.3%1,990
9. Dyspnoeashortness of breath7%1,912
10. Wheezingwheezing6.6%1,809
11. Off label useused for a purpose or in a way not on the label6.5%1,794
12. Headachehead pain6.4%1,752
13. Pneumonialung infection6%1,643
14. Malaisegeneral feeling of being unwell5.9%1,619
15. Fatiguetiredness5.8%1,585
16. Toxicity to various agentspoisoning or toxic effect of one or more substances5.7%1,558
17. Asthmaasthma5.7%1,552
18. Dizzinesslight-headedness or unsteadiness5.6%1,546
19. Depressionlow mood5.6%1,539
20. Confusional stateconfusion5.4%1,490
21. Deaththe patient died; cause not stated by this term5.3%1,451
22. Arthralgiajoint pain5.3%1,448
23. Hypertensionhigh blood pressure5.1%1,399
24. Rashskin rash5%1,365
25. Diarrhoealoose or frequent stools4.6%1,266
26. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease4.6%1,261
27. Oedemaswelling from fluid4.5%1,248
28. Hypersensitivityan allergic-type reaction4.5%1,242
29. Weight increasedweight gain4.5%1,235
30. General physical health deteriorationgeneral decline in health4.5%1,229

Top 30 of 1,869 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 42 drugs in the opioid agonist 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 965,051 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. 47.1% 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 27,447 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tramadol 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 opioid agonist 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 Tramadol hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (10,478) 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.