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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\IBUPROFEN: 3,006 Adverse Event Reports & Safety Profile

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3,006
Total FAERS Reports
21 (0.7%)
Deaths Reported
59
Hospitalizations
3,006
As Primary/Secondary Suspect
31
Life-Threatening
35
Disabilities

First Report: 20000101 · Latest Report: 20280701

What Are the Most Common ACETAMINOPHEN\IBUPROFEN Side Effects?

#1 Most Reported
Product use in unapproved indication
1,730 reports (57.6%)
#2 Most Reported
Drug effective for unapproved indication
1,620 reports (53.9%)
#3 Most Reported
Drug ineffective
397 reports (13.2%)

All ACETAMINOPHEN\IBUPROFEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product use in unapproved indication 1,730 57.6% 12 14
Drug effective for unapproved indication 1,620 53.9% 0 0
Drug ineffective 397 13.2% 8 11
Drug effect less than expected 163 5.4% 0 0
Therapeutic product effect incomplete 159 5.3% 1 1
Drug ineffective for unapproved indication 97 3.2% 0 0
Therapeutic response unexpected 91 3.0% 0 0
Abdominal discomfort 76 2.5% 16 18
Incorrect dose administered 53 1.8% 0 0
Abdominal pain upper 52 1.7% 16 20
Hypersensitivity 48 1.6% 16 20
Pruritus 43 1.4% 16 18
Off label use 41 1.4% 17 19
Dyspnoea 39 1.3% 17 21
Inappropriate schedule of product administration 39 1.3% 1 1
Rash 39 1.3% 16 22
Product use issue 38 1.3% 15 16
Fatigue 36 1.2% 11 14
Discomfort 35 1.2% 16 18
Stomatitis 35 1.2% 21 23

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

Gender: 70.0% female, 30.0% male. Average age: 54.7 years. Most reports from: US. View detailed demographics →

Is ACETAMINOPHEN\IBUPROFEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2011 1 0 1
2015 1 0 1
2017 1 0 0
2018 7 0 6
2019 1 0 1
2020 17 0 0
2021 23 0 4
2022 15 0 0
2023 130 0 1
2024 16 0 3
2025 18 0 2
2028 1 0 0

View full timeline →

What Is ACETAMINOPHEN\IBUPROFEN Used For?

IndicationReports
Migraine 673
Pain 656
Headache 560
Back pain 513
Product used for unknown indication 425
Inflammation 152
Arthralgia 124
Pyrexia 102
Dysmenorrhoea 92
Myalgia 80

ACETAMINOPHEN\IBUPROFEN vs Alternatives: Which Is Safer?

ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\METHOCARBAMOL ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\OPIUM ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\OXYCODONE ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\OXYCODONE\OXYCODONE ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\PROPOXYPHENE ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\PSEUDOEPHEDRINE ACETAMINOPHEN\IBUPROFEN vs ACETAMINOPHEN\TRAMADOL ACETAMINOPHEN\IBUPROFEN vs ACETAZOLAMIDE ACETAMINOPHEN\IBUPROFEN vs ACETYLCYSTEINE

Official FDA Label for ACETAMINOPHEN\IBUPROFEN

Official prescribing information from the FDA-approved drug label.