Percocet: adverse event reports filed with FDA

57,793

reports as suspect product

0.3% of all reports · about 2,569 a year

198

reports, 12 months to June 2026

490 in the 12 months before

95.4%

marked serious by the reporter

91.7% across the class

42.6%

record death among outcomes, as reported

24,611 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 Percocet reports recording the termmedian drug in opioid agonist

1. Dependence32.5%18,771
2. Overdosea dose above the recommended amount26.9%15,551
3. Deaththe patient died; cause not stated by this term26.2%15,162
4. Toxicity to various agentspoisoning or toxic effect of one or more substances16.3%9,426
5. Drug dependencedependence on a medicine14.8%8,557
6. Ill-defined disordera condition that was not clearly described10.1%5,836
7. Drug withdrawal syndrome neonatal5.6%3,252
8. Drug abusemisuse of a medicine5.1%2,949
9. Withdrawal syndrome4.9%2,844
10. Painpain, site not specified4.5%2,607
11. Foetal exposure during pregnancythe unborn baby was exposed to the medicine4.2%2,405
12. Drug withdrawal syndromesymptoms on stopping a medicine3.9%2,255
13. Depressionlow mood3%1,757
14. Emotional distressemotional distress2.7%1,572
15. Anxietyanxiety2.2%1,246
16. Developmental delayslower development in a child1.9%1,072
17. Drug hypersensitivityan allergic-type reaction to a medicine1.8%1,044
18. Drug ineffectivethe medicine did not work as expected1.5%853
19. Maternal exposure during pregnancythe mother took the medicine during pregnancy1.3%764
20. Accidental overdosean accidental overdose1.3%759
21. Vomitingbeing sick1.2%715
22. Nauseafeeling sick1.2%692
23. Insomniadifficulty sleeping1.1%646
24. Drug diversion1.1%631
25. Learning disability1%582
26. Gastrointestinal disorder1%566
27. Headachehead pain0.9%522
28. Mental disorder0.9%518
29. Constipationconstipation0.9%501
30. Asthmaasthma0.9%498

Top 30 of 1,403 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. 98.2% 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 57,793 reports.

Drugs most often listed in the same reports

Other products listed in reports where Percocet 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 Percocet as a suspect or interacting product; reports listing it only as a concomitant medication (38,242) 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.