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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.

XYLOMETAZOLINE: 539 Adverse Event Reports & Safety Profile

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539
Total FAERS Reports
217 (40.3%)
Deaths Reported
254
Hospitalizations
539
As Primary/Secondary Suspect
164
Life-Threatening
185
Disabilities
Lydia Co., Ltd.
Manufacturer

Route: NASAL · Manufacturer: Lydia Co., Ltd. · HUMAN OTC DRUG · FDA Label: Available

First Report: 1966 · Latest Report: 20240218

What Are the Most Common XYLOMETAZOLINE Side Effects?

#1 Most Reported
Off label use
161 reports (29.9%)
#2 Most Reported
Nausea
155 reports (28.8%)
#3 Most Reported
Abdominal distension
155 reports (28.8%)

All XYLOMETAZOLINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 161 29.9% 151 126
Abdominal distension 155 28.8% 155 114
Nausea 155 28.8% 141 110
Hyponatraemia 154 28.6% 154 112
Stress 152 28.2% 151 109
Multiple organ dysfunction syndrome 151 28.0% 151 109
Abdominal pain 149 27.6% 146 107
General physical health deterioration 148 27.5% 147 106
Appendicitis 147 27.3% 147 106
Vomiting 147 27.3% 139 102
Appendicolith 146 27.1% 146 105
Ascites 146 27.1% 146 105
Constipation 146 27.1% 143 104
Condition aggravated 145 26.9% 141 115
Sepsis 144 26.7% 144 101
Somnolence 144 26.7% 140 113
Cardiogenic shock 142 26.4% 142 101
Ventricular fibrillation 139 25.8% 139 107
Drug dependence 131 24.3% 1 1
Dry mouth 131 24.3% 129 102

Who Reports XYLOMETAZOLINE Side Effects? Age & Gender Data

Gender: 26.7% female, 73.3% male. Average age: 70.4 years. Most reports from: CA. View detailed demographics →

Is XYLOMETAZOLINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 0
2004 1 0 0
2005 1 0 0
2006 3 0 0
2009 1 0 0
2010 2 0 2
2011 9 0 0
2013 5 0 0
2014 9 0 4
2015 14 0 4
2016 3 1 0
2017 6 0 6
2018 7 0 6
2019 2 0 1
2020 47 47 41
2021 17 8 10
2022 4 0 2
2023 6 0 5
2024 3 0 0

View full timeline →

What Is XYLOMETAZOLINE Used For?

IndicationReports
Dyspnoea 188
Product used for unknown indication 155
Nasal congestion 83
Nasopharyngitis 9
Rhinitis allergic 9
Hypersensitivity 8
Nutritional supplementation 8
Bronchitis 6
Multiple allergies 5
Nasal obstruction 5

XYLOMETAZOLINE vs Alternatives: Which Is Safer?

XYLOMETAZOLINE vs XYREM XYLOMETAZOLINE vs XYREM , /ML XYLOMETAZOLINE vs YASMIN XYLOMETAZOLINE vs YAZ XYLOMETAZOLINE vs YTTRIUM Y-90 XYLOMETAZOLINE vs ZAFIRLUKAST XYLOMETAZOLINE vs ZALCITABINE XYLOMETAZOLINE vs ZALEPLON XYLOMETAZOLINE vs ZANAMIVIR XYLOMETAZOLINE vs ZANIDATAMAB

Official FDA Label for XYLOMETAZOLINE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Adults and children 7 years and older: Spray into the nose 3 times a day

Dosage & Administration

for nasal use

Warnings

■ When using this product Stop use and ask a doctor if nervousness, diziness, or sleepness occur. Pain, nasal congestion or cough gets worse or lasts more than 7 days. fever gets worse or lasts more than 3 days New symtoms occur. keep out of reach of children. In case of overdose, get medical help or contact a poison contral center right away. If pregnant or breast-feeding, ask a health professional before use.

Active Ingredient

Xylometazoline Hydrochloride

Inactive Ingredients

l-menthol, eucalyptus oil, etc