Nucynta: adverse event reports filed with FDA

27,575

reports as suspect product

0.1% of all reports · about 1,622 a year

127

reports, 12 months to June 2026

244 in the 12 months before

90.4%

marked serious by the reporter

91.7% across the class

71%

record death among outcomes, as reported

19,571 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 Nucynta reports recording the termmedian drug in opioid agonist

1. Deaththe patient died; cause not stated by this term41.6%11,461
2. Toxicity to various agentspoisoning or toxic effect of one or more substances33.4%9,218
3. Overdosea dose above the recommended amount21%5,801
4. Drug abusemisuse of a medicine4.9%1,363
5. Drug dependencedependence on a medicine3.5%952
6. Drug withdrawal syndrome neonatal3.4%930
7. Accidental overdosean accidental overdose2.3%636
8. Drug ineffectivethe medicine did not work as expected2.2%601
9. Medication errora mistake in prescribing, dispensing or taking a medicine1.6%453
10. Painpain, site not specified1.4%394
11. Intentional product misusedeliberate use not as intended1.2%340
12. Nauseafeeling sick1%287
13. Drug withdrawal syndromesymptoms on stopping a medicine0.9%253
14. Drug dose omissiona dose was missed0.8%218
15. Dizzinesslight-headedness or unsteadiness0.7%202
16. Feeling abnormalfeeling odd or not right0.7%191
17. Headachehead pain0.6%172
18. Somnolencedrowsiness0.6%170
19. Dependence0.6%165
20. Vomitingbeing sick0.6%163
21. Insomniadifficulty sleeping0.5%149
22. Drug diversion0.5%145
23. Adverse eventan unwanted medical event, type not specified0.5%138
24. Depressionlow mood0.5%135
25. Product quality issuea problem with the product itself0.5%132
26. Withdrawal syndrome0.5%131
27. Malaisegeneral feeling of being unwell0.5%130
28. Hallucinationseeing or hearing things that are not there0.5%128
29. Hepatitis Chepatitis C infection0.5%126
30. Product use in unapproved indicationused for a purpose not on the label0.5%126

Top 30 of 527 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. 98.1% 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 27,575 reports.

Drugs most often listed in the same reports

Other products listed in reports where Nucynta 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 Nucynta as a suspect or interacting product; reports listing it only as a concomitant medication (2,318) 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.