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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ACETAMINOPHEN\TRAMADOL: 5,548 Adverse Event Reports & Safety Profile

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5,548
Total FAERS Reports
573 (10.3%)
Deaths Reported
2,486
Hospitalizations
5,548
As Primary/Secondary Suspect
437
Life-Threatening
219
Disabilities

Active Ingredient: ACETAMINOPHEN\TRAMADOL HYDROCHLORIDE ·

First Report: 1997 · Latest Report: 20250718

What Are the Most Common ACETAMINOPHEN\TRAMADOL Side Effects?

#1 Most Reported
Nausea
685 reports (12.3%)
#2 Most Reported
Drug ineffective
662 reports (11.9%)
#3 Most Reported
Vomiting
619 reports (11.2%)

All ACETAMINOPHEN\TRAMADOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Nausea 685 12.4% 63 229
Drug ineffective 662 11.9% 79 220
Vomiting 619 11.2% 96 309
Off label use 570 10.3% 126 181
Pain 407 7.3% 73 177
Malaise 374 6.7% 76 162
Product use in unapproved indication 366 6.6% 65 102
Hyperhidrosis 365 6.6% 5 19
Dyspnoea 360 6.5% 79 184
Somnolence 344 6.2% 13 150
Suicide attempt 321 5.8% 1 173
Sedation 320 5.8% 1 20
Intentional overdose 316 5.7% 7 187
Dizziness 315 5.7% 70 153
Fall 305 5.5% 50 220
Drug hypersensitivity 303 5.5% 53 66
Nightmare 300 5.4% 0 3
Confusional state 272 4.9% 86 208
Headache 271 4.9% 55 129
Condition aggravated 237 4.3% 112 161

Who Reports ACETAMINOPHEN\TRAMADOL Side Effects? Age & Gender Data

Gender: 58.1% female, 41.9% male. Average age: 59.8 years. Most reports from: JP. View detailed demographics →

Is ACETAMINOPHEN\TRAMADOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2001 1 0 0
2002 3 1 0
2003 3 0 0
2005 6 1 2
2006 3 2 2
2007 5 0 2
2008 5 0 3
2009 10 0 8
2010 19 0 17
2011 18 1 10
2012 35 5 13
2013 85 9 43
2014 226 16 135
2015 308 25 176
2016 419 69 239
2017 413 32 234
2018 367 47 211
2019 273 15 138
2020 268 9 164
2021 252 8 143
2022 180 12 86
2023 140 4 89
2024 45 4 12
2025 60 2 39

View full timeline →

What Is ACETAMINOPHEN\TRAMADOL Used For?

IndicationReports
Product used for unknown indication 2,173
Pain 1,270
Migraine 280
Back pain 254
Arthralgia 123
Analgesic therapy 107
Rheumatoid arthritis 58
Suicide attempt 47
Osteoarthritis 43
Neuralgia 41

ACETAMINOPHEN\TRAMADOL vs Alternatives: Which Is Safer?

ACETAMINOPHEN\TRAMADOL vs ACETAZOLAMIDE ACETAMINOPHEN\TRAMADOL vs ACETYLCYSTEINE ACETAMINOPHEN\TRAMADOL vs ACETYLLEUCINE ACETAMINOPHEN\TRAMADOL vs ACETYLLEUCINE, L- ACETAMINOPHEN\TRAMADOL vs ACETYLSALICYLIC ACID ACETAMINOPHEN\TRAMADOL vs ACITRETIN ACETAMINOPHEN\TRAMADOL vs ACLARUBICIN ACETAMINOPHEN\TRAMADOL vs ACLASTA ACETAMINOPHEN\TRAMADOL vs ACLIDINIUM ACETAMINOPHEN\TRAMADOL vs ACLIDINIUM\FORMOTEROL

Official FDA Label for ACETAMINOPHEN\TRAMADOL

Official prescribing information from the FDA-approved drug label.