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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\PSEUDOEPHEDRINE: 185 Adverse Event Reports & Safety Profile

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185
Total FAERS Reports
21 (11.4%)
Deaths Reported
131
Hospitalizations
185
As Primary/Secondary Suspect
38
Life-Threatening
34
Disabilities

First Report: 19990914 · Latest Report: 20230819

What Are the Most Common ACETAMINOPHEN\PSEUDOEPHEDRINE Side Effects?

#1 Most Reported
Drug ineffective
106 reports (57.3%)
#2 Most Reported
Pyrexia
91 reports (49.2%)
#3 Most Reported
Infusion related reaction
91 reports (49.2%)

All ACETAMINOPHEN\PSEUDOEPHEDRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 106 57.3% 11 94
Infusion related reaction 91 49.2% 11 91
Pyrexia 91 49.2% 12 91
Pain 89 48.1% 9 89
Off label use 88 47.6% 12 88
Headache 87 47.0% 12 82
Macular degeneration 85 46.0% 0 78
Nausea 82 44.3% 8 80
Rectal haemorrhage 81 43.8% 8 81
Abdominal pain 79 42.7% 9 78
Malaise 78 42.2% 7 78
Colitis ulcerative 77 41.6% 8 77
Therapeutic product effect incomplete 77 41.6% 1 77
Weight decreased 76 41.1% 6 76
Dyspepsia 75 40.5% 4 75
Frequent bowel movements 74 40.0% 6 74
Female genital tract fistula 73 39.5% 0 73
Erythema 72 38.9% 3 71
Haematochezia 72 38.9% 0 72
Radiculopathy 72 38.9% 0 72

Who Reports ACETAMINOPHEN\PSEUDOEPHEDRINE Side Effects? Age & Gender Data

Gender: 75.7% female, 24.3% male. Average age: 56.3 years. Most reports from: CA. View detailed demographics →

Is ACETAMINOPHEN\PSEUDOEPHEDRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 0
2010 1 0 1
2012 3 0 1
2013 1 0 0
2014 1 0 1
2015 5 0 3
2016 3 0 2
2017 2 0 1
2018 4 0 2
2019 2 0 0
2022 3 0 2
2023 3 0 0

View full timeline →

What Is ACETAMINOPHEN\PSEUDOEPHEDRINE Used For?

IndicationReports
Product used for unknown indication 140
Nasopharyngitis 7
Headache 6

ACETAMINOPHEN\PSEUDOEPHEDRINE vs Alternatives: Which Is Safer?

ACETAMINOPHEN\PSEUDOEPHEDRINE vs ACETAMINOPHEN\TRAMADOL ACETAMINOPHEN\PSEUDOEPHEDRINE vs ACETAZOLAMIDE ACETAMINOPHEN\PSEUDOEPHEDRINE vs ACETYLCYSTEINE ACETAMINOPHEN\PSEUDOEPHEDRINE vs ACETYLLEUCINE ACETAMINOPHEN\PSEUDOEPHEDRINE vs ACETYLLEUCINE, L- ACETAMINOPHEN\PSEUDOEPHEDRINE vs ACETYLSALICYLIC ACID ACETAMINOPHEN\PSEUDOEPHEDRINE vs ACITRETIN ACETAMINOPHEN\PSEUDOEPHEDRINE vs ACLARUBICIN ACETAMINOPHEN\PSEUDOEPHEDRINE vs ACLASTA ACETAMINOPHEN\PSEUDOEPHEDRINE vs ACLIDINIUM

Official FDA Label for ACETAMINOPHEN\PSEUDOEPHEDRINE

Official prescribing information from the FDA-approved drug label.