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Tapentadol Side Effects

The most commonly reported side effects of tapentadol include death, toxicity to various agents, and overdose, based on 33,847 FDA adverse event reports from 2004 to 2025. 2.9% of reports found the drug to be ineffective.

Tapentadol side effects

Percentages show how often each reaction appears relative to total reports for tapentadol.

1
Death34.4%11,650
2
Toxicity To Various Agents28.7%9,714
3
Overdose17.4%5,883
4
Drug Abuse4.6%1,546
5
Drug Dependence3.1%1,063
6
Drug Ineffective2.9%996
7
Drug Withdrawal Syndrome Neonatal2.8%944
8
Pain2.2%739
9
Accidental Overdose2.1%702
10
Nausea2.0%690
11
Fatigue1.2%423
12
Intentional Product Misuse1.2%400
13
Vomiting1.2%393
14
Headache1.2%390
15
Somnolence1.1%383

These are voluntary reports and do not establish that tapentadol caused these reactions.

Report severity

89.8%Serious30,395 reports
14.4%Hospitalizations4,861 reports
61.1%Fatal20,677 reports

Seriousness is determined by the reporter, not by OpenClaim.

Tapentadol drug interactions

Other drugs that appear in adverse event reports alongside tapentadol. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Oxycodone68.6%23,205
2
Acetaminophen68.3%23,103
3
Fentanyl67.8%22,960
4
Morphine-sulfate67.1%22,699
5
Hydromorphone-hydrochloride67.0%22,681
6
Oxymorphone-hydrochloride66.7%22,584
7
Aspirin66.4%22,477
8
Buprenorphine65.2%22,071
9
Hydrocodone63.8%21,608
10
Ibuprofen19.4%6,582
11
Methadone-hydrochloride2.6%886
12
Tramadol-hydrochloride2.3%781
13
Pregabalin1.8%600
14
Sodium-oxybate1.1%368
15
Duloxetine-hydrochloride1.1%365

Taken alongside

1
Acetaminophen3.8%1,295
2
Pregabalin3.2%1,083
3
Gabapentin3.0%1,007
4
Oxycodone2.7%910
5
Duloxetine-hydrochloride2.3%784
6
Aspirin2.2%753
7
Ergocalciferol2.2%748
8
Omeprazole2.2%744
9
Levothyroxine-sodium2.1%702
10
Atorvastatin-calcium1.7%572
11
Furosemide1.7%563
12
Pantoprazole-sodium1.7%560
13
Amlodipine1.6%528
14
Albuterol1.5%512
15
Ondansetron1.5%496

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports tapentadol side effects

17.3% of tapentadol adverse event reports involve female patients and 10.2% involve male patients. The largest age group is adult at 63%. These figures reflect who reports side effects, not underlying risk.

Sex

Female17.3%
Male10.2%
Unknown72.5%

Age group

< 22.3%
2–110.4%
12–170.6%
18–6462.9%
65+33.7%

What is tapentadol used for

Conditions and purposes for which patients were taking tapentadol when the adverse event was reported.

Abdominal PainAbdominal Pain UpperAccident At WorkAccidental Drug Intake By ChildAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAcneAnalgesiaAnalgesic TherapyAnkylosing SpondylitisAntidepressant TherapyAnxietyArachnoiditisArthralgia

Showing 15 of 478 indications

Tapentadol brand names and reporting trend

Tapentadol is sold under brand names including Tapentadol, Nucynta.

Brand names

Tapentadol5,207
Nucynta233

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking tapentadol with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.