Nucynta ERtapentadol
30,405 adverse event reports submitted to the FDA (2005–2026)
Top Reported Adverse Events
The most frequently reported events in association with Nucynta ER in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Death 11,544 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Toxicity to Various Agents 9,292 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Overdose 5,817 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Drug Abuse 1,414 reports
A report that a medication was used in a way other than prescribed, or for non-medical reasons. The term describes a pattern of use, not a judgment about the person.
Full definition in the glossary →Drug Dependence 977 reports
A report that the body or mind has come to rely on a medication, so that stopping it causes difficulty. The term describes a physical or psychological state, not a judgment about the person.
Full definition in the glossary →Drug Withdrawal Syndrome Neonatal 932 reports
Withdrawal symptoms in a newborn whose mother took certain medications during pregnancy.
Full definition in the glossary →Drug Ineffective 814 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →- Accidental Overdose 656 reports
Pain 608 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Nausea 526 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Intentional Product Misuse 362 reports
A report that a medication was deliberately used in a way other than directed. This is a usage category describing what happened, not a judgment.
Full definition in the glossary →Fatigue 335 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Headache 334 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Dizziness 322 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Somnolence 277 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 4,076 |
| Male | 2,160 |
| Unknown | 24 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 133 |
| 18-34 | 301 |
| 35-49 | 792 |
| 50-64 | 1,309 |
| 65-74 | 589 |
| 75+ | 414 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Nucynta ER. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Death | 19,901 |
| Other Serious | 7,566 |
| Hospitalization | 3,390 |
| Non-Serious | 3,305 |
| Life-Threatening | 231 |
| Disability | 135 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Nucynta ER. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2005 | 1 |
| 2008 | 2 |
| 2009 | 95 |
| 2010 | 142 |
| 2011 | 298 |
| 2012 | 395 |
| 2013 | 296 |
| 2014 | 299 |
| 2015 | 1,331 |
| 2016 | 994 |
| 2017 | 2,380 |
| 2018 | 21,533 |
| 2019 | 540 |
| 2020 | 468 |
| 2021 | 312 |
| 2022 | 290 |
| 2023 | 342 |
| 2024 | 366 |
| 2025 | 300 |
| 2026 (partial) | 21 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Nucynta ER
In FDA adverse event reports that mention Nucynta ER, these medications appeared most often in the same report.
- Oxymorphone (5,260 reports)
- Gabapentin (990 reports)
- Pregabalin (918 reports)
- Fentanyl (898 reports)
- Duloxetine (775 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026