Endocet: adverse event reports filed with FDA

9,991

reports as suspect product

0.1% of all reports · about 446 a year

146

reports, 12 months to June 2026

176 in the 12 months before

97.6%

marked serious by the reporter

91.7% across the class

12.5%

record death among outcomes, as reported

1,246 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 Endocet reports recording the termmedian drug in opioid agonist

1. Dependence84.7%8,458
2. Overdosea dose above the recommended amount37.4%3,732
3. Ill-defined disordera condition that was not clearly described24.6%2,455
4. Deaththe patient died; cause not stated by this term11.2%1,122
5. Withdrawal syndrome9.5%947
6. Drug dependencedependence on a medicine4.1%407
7. Drug ineffectivethe medicine did not work as expected4.1%405
8. Sedationdrowsiness from a medicine3.7%370
9. Hyperhidrosisexcessive sweating3.7%368
10. Nauseafeeling sick3.6%358
11. Nightmarenightmares3.6%357
12. Depressionlow mood3.1%314
13. Off label useused for a purpose or in a way not on the label3%298
14. Nephrolithiasiskidney stones2.9%294
15. Product use in unapproved indicationused for a purpose not on the label2.9%293
16. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.6%260
17. Drug withdrawal syndrome neonatal2.5%248
18. Anxietyanxiety2.3%227
19. Painpain, site not specified1.5%153
20. Drug withdrawal syndromesymptoms on stopping a medicine1.1%108
21. Emotional distressemotional distress1%100
22. Drug abusemisuse of a medicine0.7%70
23. Constipationconstipation0.7%69
24. Product prescribing issue0.7%68
25. Disability0.7%66
26. Suicide attempta suicide attempt0.7%66
27. Amnesiamemory loss0.7%65
28. Maternal exposure during pregnancythe mother took the medicine during pregnancy0.6%60
29. Mental disorder0.6%58
30. Post-traumatic stress disorder0.6%58

Top 30 of 380 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. 95.1% 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 9,991 reports.

Drugs most often listed in the same reports

Other products listed in reports where Endocet 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 Endocet as a suspect or interacting product; reports listing it only as a concomitant medication (1,501) 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.