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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\GUAIFENESIN: 1,005 Adverse Event Reports & Safety Profile

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1,005
Total FAERS Reports
149 (14.8%)
Deaths Reported
38
Hospitalizations
1,005
As Primary/Secondary Suspect
4
Life-Threatening
3
Disabilities

Active Ingredient: CODEINE PHOSPHATE\GUAIFENESIN ·

First Report: 19900101 · Latest Report: 20240603

What Are the Most Common CODEINE\GUAIFENESIN Side Effects?

#1 Most Reported
Dependence
816 reports (81.2%)
#2 Most Reported
Overdose
501 reports (49.9%)
#3 Most Reported
Death
115 reports (11.4%)

All CODEINE\GUAIFENESIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dependence 816 81.2% 103 5
Overdose 501 49.9% 91 3
Death 115 11.4% 115 1
Drug ineffective 53 5.3% 9 3
Pain 51 5.1% 10 0
Drug hypersensitivity 47 4.7% 8 0
Rash 45 4.5% 9 1
Nausea 42 4.2% 2 1
Drug intolerance 41 4.1% 9 0
Psoriasis 40 4.0% 9 0
Treatment failure 40 4.0% 9 0
Upper respiratory tract infection 40 4.0% 9 0
Hypertension 39 3.9% 9 2
Ill-defined disorder 39 3.9% 4 0
Joint swelling 39 3.9% 9 0
Vomiting 38 3.8% 0 0
Pyrexia 37 3.7% 9 2
Rheumatoid arthritis 36 3.6% 9 0
Thrombocytopenia 36 3.6% 9 0
Depression 35 3.5% 4 1

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

Gender: 54.0% female, 46.0% male. Average age: 56.1 years. Most reports from: US. View detailed demographics →

Is CODEINE\GUAIFENESIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 0
2006 2 0 0
2009 1 0 1
2010 1 0 0
2012 5 1 0
2013 4 0 1
2014 8 0 2
2015 15 6 6
2016 11 0 3
2017 13 4 3
2018 6 0 0
2019 8 1 2
2020 3 0 1
2021 1 0 0
2022 3 0 2
2023 3 1 2
2024 2 0 1

View full timeline →

What Is CODEINE\GUAIFENESIN Used For?

IndicationReports
Product used for unknown indication 142
Cough 45
Pain 10

CODEINE\GUAIFENESIN vs Alternatives: Which Is Safer?

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

Official FDA Label for CODEINE\GUAIFENESIN

Official prescribing information from the FDA-approved drug label.