OxyContin: adverse event reports filed with FDA

146,263

reports as suspect product

0.7% of all reports · about 6,502 a year

584

reports, 12 months to June 2026

636 in the 12 months before

94.6%

marked serious by the reporter

91.7% across the class

25.6%

record death among outcomes, as reported

37,398 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 OxyContin reports recording the termmedian drug in opioid agonist

1. Drug dependencedependence on a medicine63.9%93,483
2. Painpain, site not specified32.7%47,762
3. Overdosea dose above the recommended amount31%45,368
4. Emotional distressemotional distress30.7%44,930
5. Drug withdrawal syndromesymptoms on stopping a medicine24%35,134
6. Deaththe patient died; cause not stated by this term14.2%20,721
7. Toxicity to various agentspoisoning or toxic effect of one or more substances7.4%10,823
8. Drug abusemisuse of a medicine4.8%7,012
9. Depressionlow mood3.9%5,724
10. Anxietyanxiety3.8%5,553
11. Drug withdrawal syndrome neonatal2.9%4,269
12. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.4%3,453
13. Mental disorder2%2,918
14. Disability2%2,860
15. Learning disability1.9%2,840
16. Unevaluable eventthe event could not be assessed1.9%2,806
17. Drug ineffectivethe medicine did not work as expected1.8%2,626
18. Nauseafeeling sick1.8%2,568
19. Developmental delayslower development in a child1.7%2,513
20. Withdrawal syndrome1.5%2,164
21. Vomitingbeing sick1.4%2,086
22. Dependence1.4%2,060
23. Constipationconstipation1.4%1,993
24. Injurya physical injury1.3%1,895
25. Insomniadifficulty sleeping1.2%1,804
26. Suicidal ideationthoughts of suicide1.2%1,799
27. Drug abuser1.2%1,715
28. Cardiac disorder1.2%1,702
29. Somnolencedrowsiness1.1%1,675
30. Road traffic accidenta road accident1.1%1,627

Top 30 of 2,533 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% 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 146,263 reports.

Drugs most often listed in the same reports

Other products listed in reports where OxyContin 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 OxyContin as a suspect or interacting product; reports listing it only as a concomitant medication (28,876) 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.