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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.

TRAMADOL\TRAMADOL: 3,933 Adverse Event Reports & Safety Profile

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3,933
Total FAERS Reports
856 (21.8%)
Deaths Reported
1,314
Hospitalizations
3,933
As Primary/Secondary Suspect
363
Life-Threatening
181
Disabilities

Active Ingredient: TRAMADOL\TRAMADOL HYDROCHLORIDE ·

First Report: 19950130 · Latest Report: 20240909

What Are the Most Common TRAMADOL\TRAMADOL Side Effects?

#1 Most Reported
Drug dependence
624 reports (15.9%)
#2 Most Reported
Drug abuse
385 reports (9.8%)
#3 Most Reported
Overdose
351 reports (8.9%)

All TRAMADOL\TRAMADOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug dependence 624 15.9% 61 110
Drug abuse 385 9.8% 128 129
Overdose 351 8.9% 103 108
Toxicity to various agents 328 8.3% 190 123
Drug use disorder 320 8.1% 13 78
Pain 265 6.7% 30 87
Drug ineffective 243 6.2% 24 78
Nausea 236 6.0% 34 106
Vomiting 234 6.0% 34 116
Death 225 5.7% 224 7
Headache 196 5.0% 43 97
Coma 194 4.9% 46 95
Somnolence 191 4.9% 41 65
Off label use 174 4.4% 35 89
Fall 161 4.1% 34 84
Fatigue 159 4.0% 44 88
Completed suicide 142 3.6% 142 32
Dyspnoea 141 3.6% 28 66
Poisoning deliberate 139 3.5% 37 77
Confusional state 138 3.5% 42 78

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

Gender: 53.4% female, 46.6% male. Average age: 46.5 years. Most reports from: FR. View detailed demographics →

Is TRAMADOL\TRAMADOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 1 0
2002 1 1 0
2003 3 0 2
2005 3 0 1
2007 10 6 2
2008 9 2 1
2009 11 2 6
2010 4 0 1
2011 5 0 0
2012 13 7 5
2013 6 0 2
2014 5 0 3
2015 19 7 15
2016 22 9 10
2017 39 15 10
2018 35 5 18
2019 41 5 18
2020 51 7 16
2021 118 48 53
2022 211 112 75
2023 608 32 298
2024 368 9 171

View full timeline →

What Is TRAMADOL\TRAMADOL Used For?

IndicationReports
Product used for unknown indication 2,406
Pain 409
Back pain 147
Analgesic therapy 47
Arthralgia 41
Pain in extremity 37
Headache 35
Neuralgia 28
Procedural pain 26
Cancer pain 20

TRAMADOL\TRAMADOL vs Alternatives: Which Is Safer?

TRAMADOL\TRAMADOL vs TRAMETINIB TRAMADOL\TRAMADOL vs TRAMETINIB DIMETHYL SULFOXIDE TRAMADOL\TRAMADOL vs TRANDOLAPRIL TRAMADOL\TRAMADOL vs TRANDOLAPRIL\VERAPAMIL TRAMADOL\TRAMADOL vs TRANEXAMIC ACID TRAMADOL\TRAMADOL vs TRANYLCYPROMINE TRAMADOL\TRAMADOL vs TRASTUZUMAB TRAMADOL\TRAMADOL vs TRASTUZUMAB-ANNS TRAMADOL\TRAMADOL vs TRASTUZUMAB DERUXTECAN TRAMADOL\TRAMADOL vs TRASTUZUMAB-DKST

Official FDA Label for TRAMADOL\TRAMADOL

Official prescribing information from the FDA-approved drug label.