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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.

IBUPROFEN\IBUPROFEN: 189 Adverse Event Reports & Safety Profile

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189
Total FAERS Reports
13 (6.9%)
Deaths Reported
39
Hospitalizations
189
As Primary/Secondary Suspect
18
Life-Threatening
12
Disabilities

Active Ingredient: IBUPROFEN\IBUPROFEN SODIUM ·

First Report: 20180101 · Latest Report: 20240922

What Are the Most Common IBUPROFEN\IBUPROFEN Side Effects?

#1 Most Reported
Drug ineffective
44 reports (23.3%)
#2 Most Reported
Product use in unapproved indication
37 reports (19.6%)
#3 Most Reported
Off label use
30 reports (15.9%)

All IBUPROFEN\IBUPROFEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 44 23.3% 5 5
Product use in unapproved indication 37 19.6% 5 6
Off label use 30 15.9% 6 11
Headache 17 9.0% 8 13
Dizziness 15 7.9% 6 9
Dyspnoea 14 7.4% 8 12
Gastrointestinal disorder 14 7.4% 7 9
Malaise 14 7.4% 10 13
Abdominal discomfort 13 6.9% 9 9
Vomiting 13 6.9% 8 11
Abdominal pain upper 12 6.4% 6 6
Diarrhoea 12 6.4% 8 9
Drug hypersensitivity 12 6.4% 7 9
Fatigue 12 6.4% 7 8
Hypertension 12 6.4% 8 8
Hypoaesthesia 12 6.4% 9 10
Nausea 12 6.4% 2 5
Peripheral swelling 12 6.4% 8 8
Rheumatoid arthritis 12 6.4% 7 7
Wrong technique in product usage process 12 6.4% 0 0

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

Gender: 58.6% female, 41.4% male. Average age: 52.2 years. Most reports from: US. View detailed demographics →

Is IBUPROFEN\IBUPROFEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 2 0 1
2019 1 0 1
2021 1 0 0
2022 2 0 0
2023 2 0 2
2024 18 0 4

View full timeline →

What Is IBUPROFEN\IBUPROFEN Used For?

IndicationReports
Product used for unknown indication 79
Pain 26
Headache 16
Arthralgia 10
Migraine 8
Rheumatoid arthritis 8
Premedication 7
Inflammation 6
Myalgia 5

IBUPROFEN\IBUPROFEN vs Alternatives: Which Is Safer?

IBUPROFEN\IBUPROFEN vs IBUPROFEN\PHENYLEPHRINE IBUPROFEN\IBUPROFEN vs IBUPROFEN\PSEUDOEPHEDRINE IBUPROFEN\IBUPROFEN vs ICATIBANT IBUPROFEN\IBUPROFEN vs ICHTHAMMOL\ZINC IBUPROFEN\IBUPROFEN vs ICLUSIG IBUPROFEN\IBUPROFEN vs ICODEXTRIN IBUPROFEN\IBUPROFEN vs ICOSAPENT IBUPROFEN\IBUPROFEN vs ICOSAPENT ETHYL IBUPROFEN\IBUPROFEN vs IDARUBICIN IBUPROFEN\IBUPROFEN vs IDARUCIZUMAB

Official FDA Label for IBUPROFEN\IBUPROFEN

Official prescribing information from the FDA-approved drug label.