Acetaminophen Oxycodone Hydrochloride Oxycodone Terephthalate: adverse event reports filed with FDA

5,914

reports as suspect product

0% of all reports · about 376 a year

53

reports, 12 months to June 2026

54 in the 12 months before

93.9%

marked serious by the reporter

57.4% across all reports

3.9%

record death among outcomes, as reported

230 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 Acetaminophen Oxycodone Hydrochloride Oxycodone Terephthalate reports recording the termall reports in the database

1. Drug dependencedependence on a medicine89.3%5,284
2. Painpain, site not specified71.5%4,230
3. Emotional distressemotional distress70.5%4,168
4. Drug withdrawal syndromesymptoms on stopping a medicine50.5%2,985
5. Overdosea dose above the recommended amount36.3%2,149
6. Anxietyanxiety9.6%565
7. Maternal exposure during pregnancythe mother took the medicine during pregnancy6.7%397
8. Depressionlow mood4%239
9. Mental disorder3.9%228
10. Drug abusemisuse of a medicine3.4%204
11. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2%118
12. Drug withdrawal syndrome neonatal1.9%113
13. Vomitingbeing sick1.6%97
14. Insomniadifficulty sleeping1.6%96
15. Injurya physical injury1.5%89
16. Amnesiamemory loss1.5%88
17. Unevaluable eventthe event could not be assessed1.4%84
18. Headachehead pain1.4%83
19. Learning disability1.4%80
20. General physical health deteriorationgeneral decline in health1.3%78
21. Illness1.2%72
22. Pruritusitching1.2%72
23. Withdrawal syndrome1.2%72
24. Off label useused for a purpose or in a way not on the label1.2%71
25. Sleep disordera sleep problem1.2%71
26. Nauseafeeling sick1.2%70
27. Fatiguetiredness1.2%69
28. Arthralgiajoint pain1.1%65
29. Diarrhoealoose or frequent stools1.1%64
30. Astheniaweakness or lack of energy1%60

Top 30 of 456 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 share of all reports in the database; 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 20,646,523 reports. 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. 95.6% 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 5,914 reports.

Drugs most often listed in the same reports

Other products listed in reports where Acetaminophen Oxycodone Hydrochloride Oxycodone Terephthalate 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."

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 Acetaminophen Oxycodone Hydrochloride Oxycodone Terephthalate as a suspect or interacting product; reports listing it only as a concomitant medication (706) 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.