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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.

CETIRIZINE\PSEUDOEPHEDRINE: 6,294 Adverse Event Reports & Safety Profile

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6,294
Total FAERS Reports
2,361 (37.5%)
Deaths Reported
2,599
Hospitalizations
6,294
As Primary/Secondary Suspect
2,729
Life-Threatening
3,208
Disabilities

Active Ingredient: CETIRIZINE HYDROCHLORIDE\PSEUDOEPHEDRINE HYDROCHLORIDE ·

First Report: 19750807 · Latest Report: 20250701

What Are the Most Common CETIRIZINE\PSEUDOEPHEDRINE Side Effects?

#1 Most Reported
Systemic lupus erythematosus
3,075 reports (48.9%)
#2 Most Reported
Drug ineffective
3,044 reports (48.4%)
#3 Most Reported
Rheumatoid arthritis
3,037 reports (48.3%)

All CETIRIZINE\PSEUDOEPHEDRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Systemic lupus erythematosus 3,075 48.9% 1,171 1,337
Drug ineffective 3,044 48.4% 834 1,042
Rheumatoid arthritis 3,037 48.3% 1,147 1,317
Pain 3,002 47.7% 991 1,150
Pemphigus 3,001 47.7% 1,020 1,220
Fatigue 2,966 47.1% 1,159 1,282
Glossodynia 2,941 46.7% 1,181 1,315
Alopecia 2,879 45.7% 961 1,162
Abdominal discomfort 2,872 45.6% 994 1,195
Rash 2,824 44.9% 1,153 1,298
Hand deformity 2,806 44.6% 1,181 1,310
Wound 2,770 44.0% 1,148 1,310
Swelling 2,743 43.6% 1,107 1,284
Infusion related reaction 2,635 41.9% 1,161 1,283
Joint swelling 2,580 41.0% 1,177 1,279
Synovitis 2,576 40.9% 1,127 1,294
Pericarditis 2,537 40.3% 992 1,194
Off label use 2,531 40.2% 1,240 1,373
Arthropathy 2,528 40.2% 896 1,097
Hepatic enzyme increased 2,479 39.4% 1,118 1,238

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

Gender: 94.7% female, 5.3% male. Average age: 47.0 years. Most reports from: CA. View detailed demographics →

Is CETIRIZINE\PSEUDOEPHEDRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2004 1 0 0
2008 3 2 2
2011 6 1 1
2012 3 0 2
2013 9 0 1
2014 57 0 3
2015 127 19 34
2016 79 0 5
2017 90 2 13
2018 49 0 5
2019 43 0 4
2020 31 0 2
2021 23 0 1
2022 30 0 3
2023 45 4 11
2024 21 0 2
2025 9 0 1

View full timeline →

What Is CETIRIZINE\PSEUDOEPHEDRINE Used For?

IndicationReports
Rheumatoid arthritis 3,854
Product used for unknown indication 1,640
Off label use 531
Multiple allergies 316
Hypersensitivity 153
Nasal congestion 126
Seasonal allergy 120
Sinus congestion 93
Foetal exposure during pregnancy 92
Rhinorrhoea 58

CETIRIZINE\PSEUDOEPHEDRINE vs Alternatives: Which Is Safer?

CETIRIZINE\PSEUDOEPHEDRINE vs CETRIMIDE CETIRIZINE\PSEUDOEPHEDRINE vs CETRORELIX CETIRIZINE\PSEUDOEPHEDRINE vs CETUXIMAB CETIRIZINE\PSEUDOEPHEDRINE vs CETYLPYRIDINIUM CETIRIZINE\PSEUDOEPHEDRINE vs CEVIMELINE CETIRIZINE\PSEUDOEPHEDRINE vs CHAMPIX CETIRIZINE\PSEUDOEPHEDRINE vs CHANTIX CETIRIZINE\PSEUDOEPHEDRINE vs CHENODIOL CETIRIZINE\PSEUDOEPHEDRINE vs CHLORAL HYDRATE CETIRIZINE\PSEUDOEPHEDRINE vs CHLORAMBUCIL

Official FDA Label for CETIRIZINE\PSEUDOEPHEDRINE

Official prescribing information from the FDA-approved drug label.