tapentadol Side Effects
Also known as: Nucynta
Analysis of 33,054 adverse event reports submitted to the FDA from 2005 to 2025.
Total Reports
33,054
Death-Related
20,529
62.1% of reports
Hospitalizations
4,458
13.5% of reports
Top Indication
Pain
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 20,529 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 11,633 |
| TOXICITY TO VARIOUS AGENTS | 8,078 |
| OVERDOSE | 5,602 |
| DRUG ABUSE | 1,213 |
| ACCIDENTAL OVERDOSE | 677 |
| DRUG DEPENDENCE | 648 |
| INTENTIONAL PRODUCT MISUSE | 327 |
| COMPLETED SUICIDE | 193 |
| DRUG DIVERSION | 109 |
| DRUG INTERACTION | 95 |
| MALIGNANT NEOPLASM PROGRESSION | 70 |
| PNEUMONIA | 66 |
| NAUSEA | 53 |
| CARDIAC ARREST | 49 |
| CONFUSIONAL STATE | 42 |
| CARDIO-RESPIRATORY ARREST | 36 |
| DECREASED APPETITE | 36 |
| PNEUMONIA ASPIRATION | 36 |
| ACCIDENT | 35 |
| CONSTIPATION | 34 |
Reactions in Hospitalization Reports
Top reactions in 4,458 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| TOXICITY TO VARIOUS AGENTS | 1,497 |
| DRUG ABUSE | 414 |
| DEATH | 332 |
| OVERDOSE | 239 |
| NAUSEA | 183 |
| PAIN | 164 |
| FALL | 151 |
| VOMITING | 150 |
| DRUG INEFFECTIVE | 140 |
| DRUG DEPENDENCE | 131 |
| SOMNOLENCE | 122 |
| ASTHENIA | 121 |
| CONFUSIONAL STATE | 121 |
| DRUG INTERACTION | 119 |
| DYSPNOEA | 116 |
| SEROTONIN SYNDROME | 112 |
| DIARRHOEA | 107 |
| PYREXIA | 103 |
| FATIGUE | 101 |
| OFF LABEL USE | 96 |
Nearby — Related Medications
What the FAERS Data Reveals About tapentadol Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 33,054 voluntary reports linked to tapentadol and its brand equivalents (Nucynta), spanning 2005 through 2025. Of those, 20,529 (62.1%) listed death as an outcome and 4,458 (13.5%) involved hospitalization. The most common indication reported alongside adverse events was Pain.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 63% were female and 36% male; age distribution skews toward 45-64, with 2,412 reports in that bracket. The single most reported reaction is death with 11,641 submissions, followed by toxicity to various agents and overdose.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.