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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.

LORATADINE\PSEUDOEPHEDRINE: 5,192 Adverse Event Reports & Safety Profile

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5,192
Total FAERS Reports
4 (0.1%)
Deaths Reported
84
Hospitalizations
5,192
As Primary/Secondary Suspect
12
Life-Threatening
11
Disabilities

Active Ingredient: LORATADINE\PSEUDOEPHEDRINE SULFATE ·

First Report: 19750101 · Latest Report: 20250905

What Are the Most Common LORATADINE\PSEUDOEPHEDRINE Side Effects?

#1 Most Reported
Drug ineffective
1,489 reports (28.7%)
#2 Most Reported
Insomnia
585 reports (11.3%)
#3 Most Reported
Product use issue
392 reports (7.6%)

All LORATADINE\PSEUDOEPHEDRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 1,489 28.7% 0 6
Insomnia 585 11.3% 0 8
Product use issue 392 7.6% 0 0
Drug effect decreased 320 6.2% 0 0
Somnolence 251 4.8% 0 30
Dizziness 219 4.2% 1 5
Off label use 169 3.3% 0 10
Dry mouth 157 3.0% 1 2
Headache 153 3.0% 0 9
Palpitations 151 2.9% 0 2
Product use in unapproved indication 140 2.7% 0 1
Extra dose administered 139 2.7% 0 0
Feeling abnormal 134 2.6% 0 1
Feeling jittery 130 2.5% 0 2
Expired product administered 103 2.0% 0 0
Therapeutic response unexpected 98 1.9% 0 0
Nervousness 96 1.9% 0 1
Wrong technique in product usage process 94 1.8% 0 0
Heart rate increased 93 1.8% 1 5
Nausea 93 1.8% 1 4

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

Gender: 69.9% female, 30.1% male. Average age: 50.5 years. Most reports from: US. View detailed demographics →

Is LORATADINE\PSEUDOEPHEDRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 3 0 0
2001 1 0 0
2002 4 0 0
2003 1 0 0
2005 2 0 0
2006 1 0 0
2007 2 0 0
2008 4 1 0
2009 2 0 0
2010 6 0 0
2011 2 0 0
2012 9 0 3
2013 12 0 2
2014 159 0 1
2015 319 0 4
2016 296 0 4
2017 305 0 4
2018 242 0 1
2019 160 0 1
2020 90 0 3
2021 76 0 7
2022 59 0 1
2023 65 0 3
2024 34 0 1
2025 15 0 1

View full timeline →

What Is LORATADINE\PSEUDOEPHEDRINE Used For?

IndicationReports
Hypersensitivity 1,682
Nasopharyngitis 1,083
Product used for unknown indication 1,056
Seasonal allergy 455
Nasal congestion 337
Rhinorrhoea 244
Sneezing 207
Eye pruritus 140
Respiratory tract congestion 127
Lacrimation increased 115

LORATADINE\PSEUDOEPHEDRINE vs Alternatives: Which Is Safer?

LORATADINE\PSEUDOEPHEDRINE vs LORAZEPAM LORATADINE\PSEUDOEPHEDRINE vs LORCASERIN LORATADINE\PSEUDOEPHEDRINE vs LORLATINIB LORATADINE\PSEUDOEPHEDRINE vs LORMETAZEPAM LORATADINE\PSEUDOEPHEDRINE vs LORNOXICAM LORATADINE\PSEUDOEPHEDRINE vs LOSARTAN LORATADINE\PSEUDOEPHEDRINE vs LOSARTAN\LOSARTAN LORATADINE\PSEUDOEPHEDRINE vs LOTEPREDNOL ETABONATE LORATADINE\PSEUDOEPHEDRINE vs LOTEPREDNOL ETABONATE\TOBRAMYCIN LORATADINE\PSEUDOEPHEDRINE vs LOTILANER

Official FDA Label for LORATADINE\PSEUDOEPHEDRINE

Official prescribing information from the FDA-approved drug label.