Oxycodone hcl: adverse event reports filed with FDA

4,700

reports as suspect product

0% of all reports · about 209 a year

0

reports, 12 months to June 2026

0 in the 12 months before

92.4%

marked serious by the reporter

91.7% across the class

54.7%

record death among outcomes, as reported

2,573 reports · not verified by FDA

Reports by month, five years

No report listing Oxycodone hcl was received in the five years to June 2026; the latest was received in September 2015.

By year received

Reactions recorded in the reports

share of Oxycodone hcl reports recording the termmedian drug in opioid agonist

1. Respiratory arrestbreathing stopped13.3%625
2. Completed suicidedeath by suicide13.1%617
3. Cardiac arrestthe heart stopped12.7%599
4. Cardio-respiratory arrestthe heart and breathing stopped7.5%351
5. Drug abusemisuse of a medicine6.9%324
6. Deaththe patient died; cause not stated by this term6.3%297
7. Multiple drug overdose5.8%273
8. Drug toxicity5.3%248
9. Toxicity to various agentspoisoning or toxic effect of one or more substances5.2%246
10. Somnolencedrowsiness5.1%238
11. Poisoning5%236
12. Overdosea dose above the recommended amount4.9%231
13. Vomitingbeing sick4.7%220
14. Drug ineffectivethe medicine did not work as expected4.4%208
15. Drug abuser4.3%204
16. Nauseafeeling sick4.2%199
17. Confusional stateconfusion3.9%185
18. Drug interactionan interaction between medicines3.4%158
19. Constipationconstipation3.3%157
20. Painpain, site not specified3.3%157
21. Drug dependencedependence on a medicine3.3%155
22. Accidental overdosean accidental overdose3.1%147
23. Intentional drug misuse3.1%145
24. Coma2.8%131
25. Drug withdrawal syndromesymptoms on stopping a medicine2.3%110
26. Headachehead pain2.3%106
27. Loss of consciousnesspassing out2.1%100
28. Dyspnoeashortness of breath1.9%89
29. Falla fall1.8%86
30. Mental status changes1.8%86

Top 30 of 806 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. 69.6% 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 4,700 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 Oxycodone hcl as a suspect or interacting product; reports listing it only as a concomitant medication (9,645) 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.