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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\PROMETHAZINE: 3,733 Adverse Event Reports & Safety Profile

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3,733
Total FAERS Reports
188 (5.0%)
Deaths Reported
23
Hospitalizations
3,733
As Primary/Secondary Suspect
2
Life-Threatening
6
Disabilities

Active Ingredient: CODEINE PHOSPHATE\PROMETHAZINE HYDROCHLORIDE ·

First Report: 19990101 · Latest Report: 20250616

What Are the Most Common CODEINE\PROMETHAZINE Side Effects?

#1 Most Reported
Dependence
3,521 reports (94.3%)
#2 Most Reported
Overdose
707 reports (18.9%)
#3 Most Reported
Back pain
421 reports (11.3%)

All CODEINE\PROMETHAZINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dependence 3,521 94.3% 146 5
Overdose 707 18.9% 131 12
Back pain 421 11.3% 0 0
Back injury 239 6.4% 0 0
Pain 169 4.5% 6 2
Death 163 4.4% 162 1
Arthralgia 122 3.3% 2 1
Road traffic accident 86 2.3% 2 2
Ill-defined disorder 83 2.2% 1 1
Spinal operation 77 2.1% 0 0
Neck pain 65 1.7% 0 0
Pain in extremity 54 1.5% 0 0
Depression 53 1.4% 6 3
Withdrawal syndrome 53 1.4% 3 2
Anxiety 51 1.4% 8 3
Intervertebral disc protrusion 50 1.3% 0 2
Joint injury 48 1.3% 0 0
Arthritis 37 1.0% 0 0
Knee operation 34 0.9% 0 0
Limb injury 34 0.9% 0 0

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

Gender: 46.4% female, 53.6% male. Average age: 44.5 years. Most reports from: US. View detailed demographics →

Is CODEINE\PROMETHAZINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 2 1 0
2007 1 0 1
2008 2 0 0
2009 1 0 1
2010 2 1 0
2013 4 2 1
2014 5 0 1
2015 7 2 1
2016 15 3 2
2017 10 2 2
2018 3 0 1
2019 5 2 0
2020 5 0 0
2021 11 3 0
2022 3 0 0
2023 3 0 1
2024 1 0 0
2025 2 0 0

View full timeline →

What Is CODEINE\PROMETHAZINE Used For?

IndicationReports
Product used for unknown indication 183
Cough 30
Pain 11

CODEINE\PROMETHAZINE vs Alternatives: Which Is Safer?

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

Official FDA Label for CODEINE\PROMETHAZINE

Official prescribing information from the FDA-approved drug label.