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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\CODEINE\PROMETHAZINE: 35 Adverse Event Reports & Safety Profile

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35
Total FAERS Reports
2 (5.7%)
Deaths Reported
26
Hospitalizations
35
As Primary/Secondary Suspect

Active Ingredient: ACETAMINOPHEN\CODEINE PHOSPHATE\PROMETHAZINE HYDROCHLORIDE ·

First Report: 20150523 · Latest Report: 20230101

What Are the Most Common ACETAMINOPHEN\CODEINE\PROMETHAZINE Side Effects?

#1 Most Reported
Linear iga disease
8 reports (22.9%)
#2 Most Reported
Erythema multiforme
7 reports (20.0%)
#3 Most Reported
Cerebrovascular accident
6 reports (17.1%)

All ACETAMINOPHEN\CODEINE\PROMETHAZINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Linear iga disease 8 22.9% 0 7
Erythema multiforme 7 20.0% 0 6
Cerebrovascular accident 6 17.1% 1 4

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

Gender: 52.0% female, 48.0% male. Average age: 45.0 years. Most reports from: ZA. View detailed demographics →

Is ACETAMINOPHEN\CODEINE\PROMETHAZINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2015 1 0 1
2017 2 2 0
2021 1 0 1
2022 1 0 0
2023 1 0 1

View full timeline →

What Is ACETAMINOPHEN\CODEINE\PROMETHAZINE Used For?

IndicationReports
Pain 17
Product used for unknown indication 10

Official FDA Label for ACETAMINOPHEN\CODEINE\PROMETHAZINE

Official prescribing information from the FDA-approved drug label.