Oxycodone: adverse event reports filed with FDA

35,671

reports as suspect product

0.2% of all reports · about 1,592 a year

2,853

reports, 12 months to June 2026

3,218 in the 12 months before

91.8%

marked serious by the reporter

91.7% across the class

44.4%

record death among outcomes, as reported

15,833 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 reports recording the termmedian drug in opioid agonist

1. Painpain, site not specified16.6%5,904
2. Drug dependencedependence on a medicine13.5%4,814
3. Drug ineffectivethe medicine did not work as expected12.8%4,572
4. Drug abusemisuse of a medicine11.9%4,258
5. Toxicity to various agentspoisoning or toxic effect of one or more substances10.8%3,863
6. Rashskin rash10.7%3,800
7. Fatiguetiredness10.4%3,700
8. Confusional stateconfusion10.2%3,651
9. Joint swellinga swollen joint9.7%3,450
10. Folliculitis9.1%3,238
11. Overdosea dose above the recommended amount9%3,224
12. Weight increasedweight gain9%3,224
13. Peripheral swellingswelling of the arms or legs9%3,208
14. Lower respiratory tract infectiona chest infection8.9%3,160
15. Swellingswelling8.8%3,131
16. Irritable bowel syndrome8.7%3,114
17. Arthralgiajoint pain8.7%3,104
18. Stomatitissore mouth8.7%3,103
19. Dyspnoeashortness of breath8.6%3,072
20. Pruritusitching8.6%3,065
21. Impaired healingslow healing8.6%3,055
22. Off label useused for a purpose or in a way not on the label8.4%2,998
23. Hypersensitivityan allergic-type reaction8.3%2,971
24. Nasopharyngitisa cold8.3%2,950
25. Pyrexiafever8.2%2,928
26. Blistera blister8.2%2,925
27. Systemic lupus erythematosuslupus, an autoimmune disease8.1%2,887
28. Muscle injury7.8%2,787
29. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease7.8%2,787
30. Sinusitissinus infection7.8%2,773

Top 30 of 2,188 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. 61.3% 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 35,671 reports.

Drugs most often listed in the same reports

Other products listed in reports where Oxycodone 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 as a suspect or interacting product; reports listing it only as a concomitant medication (72,662) 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.