Tramadol hydrochloride and acetaminophen: adverse event reports filed with FDA

557

reports as suspect product

0% of all reports · about 27 a year

22

reports, 12 months to June 2026

16 in the 12 months before

87.6%

marked serious by the reporter

91.7% across the class

14%

record death among outcomes, as reported

78 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 and acetaminophen reports recording the termmedian drug in opioid agonist

1. Nauseafeeling sick12.2%68
2. Off label useused for a purpose or in a way not on the label8.4%47
3. Drug ineffectivethe medicine did not work as expected7.4%41
4. Dizzinesslight-headedness or unsteadiness7%39
5. Vomitingbeing sick6.8%38
6. Malaisegeneral feeling of being unwell6.3%35
7. Dyspnoeashortness of breath5.6%31
8. Confusional stateconfusion4.5%25
9. Loss of consciousnesspassing out4.3%24
10. Somnolencedrowsiness4.3%24
11. Condition aggravatedthe condition being treated got worse4.1%23
12. Drug interactionan interaction between medicines4.1%23
13. Headachehead pain3.9%22
14. Drug hypersensitivityan allergic-type reaction to a medicine3.8%21
15. Drug intolerancethe medicine was not tolerated3.8%21
16. Fatiguetiredness3.8%21
17. Hand deformity3.8%21
18. Glossodynia3.6%20
19. Injurya physical injury3.6%20
20. Arthralgiajoint pain3.4%19
21. Arthropathy3.4%19
22. Dyspepsiaindigestion3.4%19
23. Falla fall3.4%19
24. Product use in unapproved indicationused for a purpose not on the label3.4%19
25. Decreased appetitereduced appetite3.2%18
26. Gait inability3.2%18
27. Hepatic enzyme increasedraised liver enzymes3.2%18
28. Infusion related reactiona reaction during or soon after an infusion3.2%18
29. Systemic lupus erythematosuslupus, an autoimmune disease3.2%18
30. Wound3.2%18

Top 30 of 315 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. 19.4% 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 557 reports.

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 and acetaminophen as a suspect or interacting product; reports listing it only as a concomitant medication (567) 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.