Oxycodone and acetaminophen: adverse event reports filed with FDA

24,919

reports as suspect product

0.1% of all reports · about 1,108 a year

112

reports, 12 months to June 2026

260 in the 12 months before

94%

marked serious by the reporter

91.7% across the class

19.8%

record death among outcomes, as reported

4,943 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 Oxycodone and acetaminophen reports recording the termmedian drug in opioid agonist

1. Drug dependencedependence on a medicine76.3%19,010
2. Overdosea dose above the recommended amount35%8,721
3. Painpain, site not specified16.4%4,082
4. Emotional distressemotional distress12.2%3,042
5. Deaththe patient died; cause not stated by this term9.5%2,360
6. Anxietyanxiety8.9%2,227
7. Foetal exposure during pregnancythe unborn baby was exposed to the medicine8.8%2,182
8. Learning disability8.7%2,180
9. Developmental delayslower development in a child8.3%2,077
10. Drug withdrawal syndrome neonatal8.3%2,073
11. Depressionlow mood7.6%1,891
12. Disability7.4%1,842
13. Drug withdrawal syndromesymptoms on stopping a medicine6.5%1,619
14. Drug abusemisuse of a medicine6%1,488
15. Drug ineffectivethe medicine did not work as expected5.6%1,407
16. Injurya physical injury4.7%1,166
17. Mental disorder4.1%1,010
18. Cardiac disorder3.7%918
19. Fatiguetiredness3.6%896
20. Dyspnoeashortness of breath3.3%826
21. Confusional stateconfusion3.2%789
22. Insomniadifficulty sleeping3.1%765
23. Pruritusitching3%747
24. Nauseafeeling sick3%744
25. Dependence2.9%732
26. Arthralgiajoint pain2.8%704
27. Headachehead pain2.8%701
28. Gastrointestinal disorder2.8%697
29. Infectionan infection, type not specified2.8%691
30. Road traffic accidenta road accident2.8%689

Top 30 of 1,565 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. 94.4% 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 24,919 reports.

Drugs most often listed in the same reports

Other products listed in reports where Oxycodone and acetaminophen 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 Oxycodone and acetaminophen as a suspect or interacting product; reports listing it only as a concomitant medication (9,234) 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.