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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.

CODEINE\IBUPROFEN: 153 Adverse Event Reports & Safety Profile

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153
Total FAERS Reports
75 (49.0%)
Deaths Reported
60
Hospitalizations
153
As Primary/Secondary Suspect
26
Life-Threatening
1
Disabilities

Active Ingredient: CODEINE PHOSPHATE\IBUPROFEN ·

First Report: 20101218 · Latest Report: 20250906

What Are the Most Common CODEINE\IBUPROFEN Side Effects?

#1 Most Reported
Overdose
42 reports (27.5%)
#2 Most Reported
Hepatic cytolysis
33 reports (21.6%)
#3 Most Reported
Coma
33 reports (21.6%)

All CODEINE\IBUPROFEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Overdose 42 27.5% 34 16
Coma 33 21.6% 23 24
Hepatic cytolysis 33 21.6% 33 20
Cardio-respiratory arrest 27 17.7% 27 12
Myocarditis 27 17.7% 27 14
Toxicity to various agents 26 17.0% 25 18
Drug abuse 25 16.3% 14 17
Somnolence 25 16.3% 25 14
Intentional overdose 24 15.7% 12 3
Drug dependence 22 14.4% 2 1
Hyperglycaemia 22 14.4% 22 14
Respiratory depression 22 14.4% 22 14
Cardiac disorder 21 13.7% 21 15
Encephalopathy 21 13.7% 21 14
Cardiomyopathy 20 13.1% 20 14
Confusional state 20 13.1% 20 13
Accidental poisoning 19 12.4% 19 14
Labelled drug-drug interaction issue 19 12.4% 19 14
Metabolic acidosis 19 12.4% 18 0
Myocardial infarction 19 12.4% 19 14

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

Gender: 44.6% female, 55.4% male. Average age: 37.9 years. Most reports from: GB. View detailed demographics →

Is CODEINE\IBUPROFEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 1 1 0
2011 2 1 0
2014 13 1 12
2015 7 6 1
2016 29 29 20
2017 1 0 0
2018 3 1 2
2019 1 0 0
2020 1 0 1
2021 2 0 2
2022 9 0 7
2023 3 0 2
2024 10 0 0
2025 3 0 2

View full timeline →

What Is CODEINE\IBUPROFEN Used For?

IndicationReports
Product used for unknown indication 70
Back pain 17
Self-medication 12
Drug dependence 8
Poisoning deliberate 7
Pain 6

CODEINE\IBUPROFEN vs Alternatives: Which Is Safer?

CODEINE\IBUPROFEN vs CODEINE\PROMETHAZINE CODEINE\IBUPROFEN vs COLCHICINE CODEINE\IBUPROFEN vs COLCHICINE\DICYCLOMINE CODEINE\IBUPROFEN vs COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE CODEINE\IBUPROFEN vs COLESEVELAM CODEINE\IBUPROFEN vs COLESTIPOL CODEINE\IBUPROFEN vs COLISTIMETHATE CODEINE\IBUPROFEN vs COLISTIN CODEINE\IBUPROFEN vs COLLAGENASE CLOSTRIDIUM HISTOLYTICUM CODEINE\IBUPROFEN vs COLLAGENASE CLOSTRIDIUM HISTOLYTICUM-AAES

Official FDA Label for CODEINE\IBUPROFEN

Official prescribing information from the FDA-approved drug label.