Oxycodone hydrochloride: adverse event reports filed with FDA

113,220

reports as suspect product

0.6% of all reports · about 5,033 a year

2,598

reports, 12 months to June 2026

2,370 in the 12 months before

94.7%

marked serious by the reporter

91.7% across the class

33.1%

record death among outcomes, as reported

37,477 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 hydrochloride reports recording the termmedian drug in opioid agonist

1. Drug dependencedependence on a medicine55.8%63,208
2. Overdosea dose above the recommended amount29.5%33,455
3. Painpain, site not specified21.8%24,730
4. Emotional distressemotional distress19.4%21,962
5. Deaththe patient died; cause not stated by this term14.8%16,702
6. Drug withdrawal syndromesymptoms on stopping a medicine13.3%15,071
7. Toxicity to various agentspoisoning or toxic effect of one or more substances12.7%14,357
8. Drug abusemisuse of a medicine6.3%7,173
9. Anxietyanxiety4.8%5,416
10. Depressionlow mood4.1%4,674
11. Drug withdrawal syndrome neonatal4%4,527
12. Foetal exposure during pregnancythe unborn baby was exposed to the medicine3.4%3,887
13. Disability3.4%3,813
14. Learning disability3.2%3,664
15. Drug ineffectivethe medicine did not work as expected3.1%3,480
16. Developmental delayslower development in a child2.9%3,339
17. Injurya physical injury2.7%3,065
18. Mental disorder2.5%2,864
19. Maternal exposure during pregnancythe mother took the medicine during pregnancy2.2%2,510
20. Fatiguetiredness2.1%2,418
21. Nauseafeeling sick2.1%2,351
22. Vomitingbeing sick2%2,252
23. Insomniadifficulty sleeping1.9%2,195
24. Confusional stateconfusion1.9%2,194
25. Unevaluable eventthe event could not be assessed1.8%2,076
26. Dyspnoeashortness of breath1.8%2,074
27. Road traffic accidenta road accident1.8%1,999
28. Cardiac disorder1.8%1,995
29. General physical health deteriorationgeneral decline in health1.8%1,991
30. Arthralgiajoint pain1.7%1,932

Top 30 of 2,304 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. 91.8% 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 113,220 reports.

Drugs most often listed in the same reports

Other products listed in reports where Oxycodone hydrochloride 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 hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (18,980) 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.