IPRATROPIUM\XYLOMETAZOLINE: 95 Adverse Event Reports & Safety Profile

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Total FAERS Reports

82 (86.3%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Active Ingredient: IPRATROPIUM BROMIDE\XYLOMETAZOLINE HYDROCHLORIDE ·

First Report: 20180205 · Latest Report: 20240614

What Are the Most Common IPRATROPIUM\XYLOMETAZOLINE Side Effects?

#1 Most Reported

Stress

74 reports (77.9%)

#2 Most Reported

Hyponatraemia

73 reports (76.8%)

#3 Most Reported

Ascites

73 reports (76.8%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Stress	74	77.9%	74	44
Appendicitis	73	76.8%	73	43
Ascites	73	76.8%	73	43
Hyponatraemia	73	76.8%	73	43
Appendicolith	72	75.8%	72	42
Cardiogenic shock	72	75.8%	72	42
General physical health deterioration	72	75.8%	72	42
Multiple organ dysfunction syndrome	72	75.8%	72	42
Ventricular fibrillation	72	75.8%	72	43
Abdominal distension	70	73.7%	70	46
Sepsis	70	73.7%	70	40
Vomiting	68	71.6%	68	44
Abdominal pain	67	70.5%	67	43
Off label use	67	70.5%	67	41
Constipation	66	69.5%	66	42
Nausea	65	68.4%	65	41
Blood phosphorus increased	55	57.9%	55	41
Condition aggravated	49	51.6%	49	39
Somnolence	49	51.6%	49	40
Dry mouth	48	50.5%	48	39

Gender: 3.5% female, 96.5% male. Average age: 79.0 years. Most reports from: CA. View detailed demographics →

Year	Reports	Deaths	Hosp.
2018	1	0	0
2020	10	10	10
2021	3	3	1
2024	2	0	0

Indication	Reports
Dyspnoea	77
Product used for unknown indication	12

Official prescribing information from the FDA-approved drug label.