MID-VOLUME · DEATH-HEAVY

tapentadol Side Effects

tapentadol (also sold as Nucynta) sits MID-VOLUME #180 of 524 by FAERS report count. Lead signal: DEATH-HEAVY - 62.1% of FAERS reports list death as an outcome (20,529 of 33,054). Demographics and serious-outcome tables follow.

Data updated 2026-05-15

33,054
FAERS reports

FDA Adverse Event Reporting System extract for tapentadol. Stamp set CASELOAD · DEATH-HEAVY · HOSP-MID. How figures are compiled.

tapentadol: 62.1% of FAERS reports list death as an outcome (20,529 of 33,054). Caseload stamp CASELOAD; volume band MID-VOLUME #180 of 524 by FAERS report count.

Mid-book FAERS page for tapentadol (Nucynta) (33,054 reports). Signature DEATH-HEAVY. Dominant age band on file: 45-64. Educational reference only.

Counts from the openFDA FAERS extract (2005–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.

DEATH leads 11,641 of 33,054 reports

DEATH
11,641
TOXICITY TO VARIOUS AGENTS
9,719
OVERDOSE
5,886
DRUG ABUSE
1,549
DRUG DEPENDENCE
1,063
DRUG WITHDRAWAL SYNDROME NEONATAL
944
PAIN
743
NAUSEA
713
ACCIDENTAL OVERDOSE
705
FATIGUE
433
HEADACHE
408
DIZZINESS
403
INTENTIONAL PRODUCT MISUSE
398
SOMNOLENCE
386
VOMITING
382
DRUG INTERACTION
353
DYSPNOEA
353
CONSTIPATION
322
FALL
317

Who reports · age peak 45-64 (SEX-BALANCED)

Sex coding · SEX-BALANCED

Female 5,453 (63%)
Male 3,147 (36%)
Unknown 29

Age peak 45-64 (2,412 reports)

0-17 176 (3%)
18-44 1,173 (21%)
45-64 2,412 (43%)
65-74 977 (18%)
75+ 843 (15%)

FAERS filings rising toward 2025

2005 2025

Reactions in Death Reports

Death-mentioned subset is HEAVY here (20,529 reports, 62.1%). Top co-reported reactions in that subset - voluntary, not causal.

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

Hospitalization mid-share (4,458, 13.5%). Co-reported reactions:

Reaction Reports
TOXICITY TO VARIOUS AGENTS 1,497
DRUG ABUSE 414
DEATH 332
OVERDOSE 239
NAUSEA 183
PAIN 164
FALL 151
VOMITING 150
DRUG DEPENDENCE 131
SOMNOLENCE 122
ASTHENIA 121
CONFUSIONAL STATE 121
DRUG INTERACTION 119
DYSPNOEA 116
SEROTONIN SYNDROME 112
DIARRHOEA 107
PYREXIA 103
FATIGUE 101
How to read tapentadol FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-MID)

FAERS holds 33,054 voluntary reports linked to tapentadol (Nucynta), 2005-2025. Death is listed on 20,529 (62.1%). Hospitalization appears on 4,458 (13.5%). Top co-reported indication: Pain.

Mid-volume extract - treat DEATH-HEAVY · HOSP-MID as signal-detection rates next to 62.1% of FAERS reports list death as an outcome (20,529 of 33,054).

Read with tapentadol

Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.